Who is the manufacturer of Velmeni for Dentists (V4D)?

Velmeni, Inc. filed the 510(k) submission for Velmeni for Dentists (V4D) (K240003).

What is the FDA product code for Velmeni for Dentists (V4D)?

MYN. It is classified under 21 CFR 892.2070 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Velmeni for Dentists (V4D)?

510(k) clearance (submission type: Traditional).

Does Velmeni for Dentists (V4D) use AI or machine learning?

Yes. Velmeni for Dentists (V4D) (K240003) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Velmeni for Dentists (V4D)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Velmeni for Dentists (V4D) get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Velmeni for Dentists (V4D)

Q: What are the predicate devices for Velmeni for Dentists (V4D)?

Overjet Caries Assist (K222746).

K240003 · Velmeni, Inc. · MYN · Aug 30, 2024 · Radiology

Device Facts

Record ID	K240003
Device Name	Velmeni for Dentists (V4D)
Applicant	Velmeni, Inc.
Product Code	MYN · Radiology
Decision Date	Aug 30, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2070
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Dental Caries Detection (standalone)	Neural network-based computer algorithm	—	Bitewing: 72.8% sensitivity; Periapical: 70.6% sensitivity; Panoramic: 68.3% sensitivity	—	—	Standalone performance study: 600 bitewing, 597 periapical, and 600 panoramic images.	3 (US licensed dentists) + 1 (oral radiologist)
Dental Caries Detection (reader improvement)	Neural network-based computer algorithm	—	Bitewing: 80.3% (aided) vs 67.5% (unaided) sensitivity; Periapical: 73.4% (aided) vs 48.7% (unaided) sensitivity; Panoramic: 27.2% (aided) vs 15.1% (unaided) sensitivity	—	—	Multi-reader fully crossed reader improvement study: 600 bitewing, 597 periapical, and 600 panoramic images.	12 (US licensed dentists) + 3 (US licensed dentists) + 1 (oral radiologist)
Dental Restorations, Fixed Prostheses, and Implants Detection (standalone)	Neural network-based computer algorithm	—	Fixed Prosthesis: 92.1% (BW), 81.0% (PA), 74.5% (PAN) sensitivity; Implant: 81.1% (BW), 94.5% (PA), 79.6% (PAN) sensitivity; Restoration: 88.1% (BW), 76.8% (PA), 72.6% (PAN) sensitivity	—	—	Standalone performance study: 600 bitewing, 597 periapical, and 600 panoramic images.	3 (US licensed dentists) + 1 (oral radiologist)
Dental Restorations, Fixed Prostheses, and Implants Detection (reader improvement)	Neural network-based computer algorithm	—	Fixed Prosthesis: 95.7% (BW), 91.1% (PA), 88.8% (PAN) aided sensitivity; Implant: 93.2% (BW), 95.9% (PA), 88.3% (PAN) aided sensitivity; Restoration: 90.8% (BW), 90.6% (PA), 73.0% (PAN) aided sensitivity	—	—	Multi-reader fully crossed reader improvement study: 600 bitewing, 597 periapical, and 600 panoramic images.	12 (US licensed dentists) + 3 (US licensed dentists) + 1 (oral radiologist)

Indications for Use

VELMENI for DENTISTS (V4D) is a concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for dentists in examining radiographs of patients' teeth. This device is not intended as a replacement for a complete examination by the dentist or their clinical judgment that considers other relevant information from the image, patient history, or actual in vivo clinical assessment. Final diagnoses and patient treatment plans are the responsibility of the dentist.

Device Story

V4D is a cloud-hosted, concurrent-read CADe software for dentists. It accepts digital bitewing, periapical, and panoramic radiographs (JPG, PNG, DCM, DEX, RVG) as input. The device uses a machine learning engine to analyze images, performing tooth numbering, condition detection (caries, restorations, fixed prostheses, implants), and segmentation. Results are returned to the user interface as graphical overlays (segmentation or bounding boxes) on the radiograph. The system includes a web interface, backend API, and an AI-worker module. It integrates with third-party patient management/imaging software via the Velmeni Bridge. Dentists use the output as a second reader to assist in clinical assessment; the device does not replace professional judgment or complete examination. Benefits include improved sensitivity in detecting dental conditions, aiding in diagnosis and treatment planning.

Clinical Evidence

Performance evaluated via standalone testing (600 bitewing, 597 periapical, 600 panoramic images) and a multi-reader, fully crossed reader improvement study (12 US dentists). Standalone testing measured sensitivity, specificity, and Dice coefficients. Reader study compared aided vs. unaided performance using wAFROC AUC, sensitivity, and specificity. Results demonstrated clear clinical benefit for bitewing and periapical views across all features, with improved sensitivity. Panoramic view showed smaller absolute benefit for caries sensitivity.

Technological Characteristics

Software-only medical image analyzer. Uses neural network-based machine learning algorithms. Cloud-hosted architecture. Inputs: digital bitewing, periapical, and panoramic radiographs (JPG, PNG, DCM, DEX, RVG). Outputs: graphical overlays (segmentation/bounding boxes) on radiographs. No patient-contacting components; no electrical/EMC requirements.

Indications for Use

Indicated for dentists to assist in clinical detection of dental caries, fillings/restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older.

Regulatory Classification

Identification

Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) A detailed description of the image analysis algorithms including a description of the algorithm inputs and outputs, each major component or block, and algorithm limitations. (ii) A detailed description of pre-specified performance testing methods and dataset(s) used to assess whether the device will improve reader performance as intended and to characterize the standalone device performance. Performance testing includes one or more standalone tests, side-by-side comparisons, or a reader study, as applicable. (iii) Results from performance testing that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures ( *e.g.,* receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain a sufficient number of cases from important cohorts (*e.g.,* subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Appropriate software documentation ( *e.g.,* device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results; and cybersecurity).(2) Labeling must include the following: (i) A detailed description of the patient population for which the device is indicated for use. (ii) A detailed description of the intended reading protocol. (iii) A detailed description of the intended user and user training that addresses appropriate reading protocols for the device. (iv) A detailed description of the device inputs and outputs. (v) A detailed description of compatible imaging hardware and imaging protocols. (vi) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level ( *e.g.,* poor image quality or for certain subpopulations), as applicable.(vii) Device operating instructions. (viii) A detailed summary of the performance testing, including: test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

Predicate Devices

Overjet Caries Assist (K222746)

Reference Devices

Second Opinion (K210365)
Denti.Al Detect (K230144)

Submission Summary (Full Text)

{0}------------------------------------------------ August 30, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text. Velmeni Inc. °/o Mini Suri CEO 333 West Maude Avenue Suite 207 SUNNYVALE, CA 94085 Re: K240003 Trade/Device Name: Velmeni for Dentists (V4D) Regulation Number: 21 CFR 892.2070 Regulation Name: Medical Image Analyzer Regulatory Class: Class II Product Code: MYN Dated: August 1, 2024 Received: August 1, 2024 Dear Mini Suri: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerelv. Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) K240003 Device Name VELMENI for DENTISTS (V4D) #### Indications for Use (Describe) VELMENI for DENTISTS (V4D) is a concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for dentists in examining radiographs of patients' teeth. This device is not intended as a replacement for a complete examination by the dentist or their clinical judgment that considers other relevant information from the image, patient history, or actual in vivo clinical assessment. Final diagnoses and patient treatment plans are the responsibility of the dentist. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # VELMENI for DENTISTS (V4D) ## 510(k) Summary K240003 In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the following 510(k) Summary for VELMENI for DENTISTS (V4D) is provided: #### Submitter Information | Submitter: | Velmeni Inc. 333 West Maude Avenue, STE 207 Sunnyvale, CA 94085 Phone: 201-289-3500 | |------------|----------------------------------------------------------------------------------------------| |------------|----------------------------------------------------------------------------------------------| June 29, 2023 Date Prepared: Contact Person: Mini Suri, CEO Velmeni Inc. Phone: 201-289-3500 Email: mini@velmeni.com #### Identification of the Device | Trade Name: | VELMENI for DENTISTS (V4D) | |----------------------|-----------------------------------------| | Common Name: | Medical image analyzer | | Classification Name | Medical image analyzer 21CFR892.2070 | | Product Code: | MYN | | Device Class: | Class II | | Predicate Device(s) | | | Predicate Device(s): | Overjet Caries Assist (K222746) | | Reference Device: | Second Opinion (K210365) | | Reference Device: | Denti.Al Detect (K230144) | ### Intended Use/ Indications for Use VELMENI for DENTISTS (V4D) is a concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for dentists in examining radiographs of patients' teeth. This device is not intended as a replacement for a complete examination by the dentist or their clinical judgment that considers other relevant information from the image, patient history, or actual in vivo clinical assessment. Final diagnoses and patient treatment plans are the responsibility of the dentist. {4}------------------------------------------------ # Device Description V4D software medical device comprises of the following key components: - Web Application Interface delivers front-end capabilities and is the point of interaction between the device and the user. - Machine Learning (ML) Engine delivers V4D's core ML capabilities through the radiograph type classifier, condition detection module, tooth numbering module, and merging module. - Backend API allows interaction between all the components, as defined in this section, in order to fulfill the user's requests on the web application interface. - Queue receives and stores messages from Backend API to send to Al-Worker. ● - Al-Worker accepts radiograph analysis requests from Backend API via the Queue, ● passes gray scale radiographs to the ML Engine in the supported extensions (jpeg and png), and returns the ML analysis results to the Backend API. - Database and File Storage store critical information related to the application, including ● user data, patient profiles, analysis results, radiographs, and associated data. The following non-medical interfaces are also available with VELMENI for DENTISTS (V4D): - . VELMENI BRIDGE (VB) acts as a conduit enabling data and information exchange between Backend API and third-party software like Patient Management or Imaging Software - Rejection Review (RR) module captures the ML-detected conditions rejected by dental ● professionals to aid in future product development and to be evaluated in accordance with VELMENIs post-market surveillance procedure. # Substantial Equivalence The proposed VELMENI for DENTISTS (V4D) has similar indications for use to, and uses the same fundamental technology as, the legally marketed predicate device to which substantial equivalence is claimed, the Overiet Caries Assist (K2222746) device. Reference devices are included for comparison for detection features and image types. | Specification | Proposed Device: Velmeni For Dentists (V4D) | Predicate Device: Overjet Caries Assist K222746 | Reference Device: Denti.Al Detect K230144 | Reference Device: Second Opinion K210365 | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Velmeni Inc. | Overjet Inc. | Denti.Al Technology Inc. | Pearl Inc. | | Classification | 892.2070 | 892.2070 | 892.2070 | 892.2070 | | Product Code | MYN | MYN | MYN | MYN | | Specification | Proposed Device: Velmeni For Dentists (V4D) | Predicate Device: Overjet Caries Assist K222746 | Reference Device: Denti.Al Detect K230144 | Reference Device: Second Opinion K210365 | | Image Modality | Radiograph | Radiograph | Radiograph | Radiograph | | Intended Use | To aid in clinical detection of pathologic and/or non-pathological dental features in radiographs of permanent teeth | To aid in clinical detection of pathologic and/or non- pathological dental features in radiographs of permanent teeth | To aid in clinical detection of pathologic and/or non-pathological dental features in radiographs of permanent teeth | To aid in clinical detection of pathologic and/or non-pathological dental features in radiographs of permanent teeth | | Indications | Velmeni for Dentists (V4D) is a concurrent-read, computer-assisted detection software intended to assist dentist in the clinical detection of dental caries, fillings/ restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for dentists in examining radiographs of patients' teeth. This device is not intended as a replacement for a complete examination by the dentist or their clinical judgment that considers other relevant | The Overjet Caries Assist (OCA) is a radiological, automated, concurrent read, computer- assisted detection software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of tooth surface suspected of being carious. The device is not intended as a replacement for complete dentist's review or their clinical judgment that takes into account other relevant information from the image, | Denti.Al Detect is a Computer- Assisted Detection (CADe) software device intended to be used by dental professionals, comprising dentists and dental specialists, while reading extraoral and intraoral 2D dental radiographs. The device aims to assist in detecting and highlighting uncategorized regions of interest (ROIs) within the teeth area, which include caries and periapical radiolucency, as a second reader. The device is also intended to aid in the measurements of mesial and distal bone levels associated with each tooth. The device is aimed | Second Opinion® is a computer aided detection ("CADe") software to identify and mark regions in relation to suspected dental findings which include Caries, Discrepancy at the margin of an existing restoration, Calculus, Periapical radiolucency, Crown (metal, including zirconia & non-metal), Filling (metal & non- metal), Root canal, Bridge, and Implants. It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older as a | | Specification | Propos ed Device: Velmeni For Dentists (V4D) | Predicate Device: Overjet Caries Assist K222746 | Reference Device: Denti.Al Detect K230144 | Reference Device: Second Opinion K210365 | | | information from the image, patient history, or actual in vivo clinical assessment. Final diagnosis and patient treatment plans are the responsibility of the dentist. | patient history, and actual in vivo clinical assessment. | to be used with images from the patients of 22 years age and older without remaining primary dentition. The device is not intended to replace a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history. | second reader. | | Intended Body Part | Dental/teeth | Dental/teeth | Dental/teeth | Dental/teeth | | End User | Licensed Dental Professional | Dentist | Dental Professional | Dental Clinicians | | Patient Population | Patients requiring dental services, all sexes, at least 15 years of age, and with permanent dentition | Patients requiring dental services, all sexes, at least 12 years of age, and with permanent dentition | Patients requiring dental services, all sexes, at least 22 years of age or older | Patients requiring dental services, all sexes, at least 12 years of age or older | | Prescriptio n or OTC | Prescription Use | Prescription Use | Prescription Use | Prescription Use | | Reader Workflow | Concurrent Read | Concurrent Read | Second Read | Second Read | | Image Source | JPG, JPEG, PNG or DCM, DEX, and RVG | JPG, PNG, EOP, JIF, DICOM | JPEG, JPG, TIFF, TIF, PNG, BMP, DICOM | RVG, DICOM, JPEG, TIFF, PNG | | Cloud Hosted Software | Yes | Yes | Yes | Yes | | Data Input | Digital intraoral files of bitewing and periapical radiographs and digital extraoral files of panoramic radiograph | Digital files of bitewing and periapical radiographs | Intraoral (bitewing and periapical) Extraoral (panoramic) | Digital intraoral files of bitewing and periapical radiographs | | Model | Machine Learning | Machine Learning | Machine Learning | Machine Learning | | Tooth Numbering | Yes | Yes | Unknown | Unknown | | Detection | Caries, restorations, fixed prostheses, and implants | Caries | Caries and periapical radiolucency | Caries, margin discrepancy-MD, calculus. periapical radiolucency-PR, crown, bridges, implants, root canals, and fillings | | Segmentation | Yes | Yes | Regions of Interest (ROIs) | No | | Bounding Boxes | Yes | Unknown | Unknown | Yes | Table 1. Comparison of the Proposed Device. Predicate Device and Reference Devices {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ # Technological Characteristics As shown in Table 1 above, the proposed VELMENI for DENTISTS (V4D) device and the predicate device have similar indications for use and uses the same fundamental technology (i.e., machine learning technology). Differences in technological characteristics include that each device uses its own proprietary algorithm to analyze digital radiographs. The proposed device's output is not limited to caries but includes restorations, fixed prostheses, and implants. Reference devices were identified because they demonstrate the Agency's familiarity with computer-assisted technology and the ability to identify and detect conditions beyond caries and in radiographs other than bitewing and periapical. The differences in technological characteristics do not raise new or different questions of safety or effectiveness. The proposed device and the predicate device are technologically equivalent as follows: - Both devices are designed to process digital bitewing and periapical radiographs. - Both devices use neural network-based computer algorithms. ● - Both devices mark detections within the user interface with a graphical overlay on the radiograph. - . Both devices produce near-instantaneous detection results. - Both devices are for prescription use. ● - Both devices utilize cloud-hosted solutions. ● {8}------------------------------------------------ The proposed device and the predicate device are technologically different as follows: - The proposed device can detect other dental features (i.e., restorations, fixed prostheses, . and implants) in addition to dental caries. The ability to detect other dental features has been cleared in other devices within this same requlation and product code. - The proposed device is capable of making detections in panoramic radiographs in addition to the bitewing and periapical radiographs. The ability to detect dental features in panoramic radiographs has been cleared in other devices within the same requlation and product code. - The proposed device will be used on patient images from 15 years old or older with permanent teeth. The use of the device in patients as young as 12 years of age with permanent teeth has already been cleared within the predicate device. - . Once suspected findings are detected in a radiograph, the proposed device overlays the radiograph with segmentation on the radiograph or alternatively a bounding box outlining the detected regions of suspected caries, restorations, fixed prosthesis, and implants, while predicate device does so with segmented polygons outlining the detected regions of suspected caries or fills suspected caries. - . The proposed device utilizes a different list of compatibility of image types as compared to the predicate device. # Performance Data # Biocompatibilitv Testing: There are no direct or indirect patient-contacting components of the proposed device. Therefore, patient contact information and biocompatibility testing are not applicable for this device. # Electrical Safety and Electromagnetic Compatibility (EMC): The proposed device is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type. Therefore, electrical safety and EMC testing is not applicable for this device. # Software Verification and Validation Tests: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submission for Device Software Functions." Verification of the software was conducted to ensure that the product works as designed. Validation was conducted to validate the design and the performance of the device to meet user needs and intended uses. VELMENI FOR DENTISTS (V4D) passed all verification and validation software tests. Overall, the VELMENI for DENTISTS (V4D) was found to be safe and effective for all intended users, uses, and use environments. # Animal Testing: Animal studies were not necessary to establish the substantial equivalence of this device. # Bench Testing and Clinical Testing: Velmeni Inc. conducted performance testing according to FDA's Guidance for Industry and Food and Drug Administration Staff, "Computer-Assisted Detection Devices Applied to Radiology Images and Radiological Device Data- Premarket Notification (510(k)) Submissions," as part of the development of VELMENI for DENTISTS (V4D). Performance testing included standalone testing and clinical reader evaluation. {9}------------------------------------------------ #### Standalone Performance . Stan…

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