Who is the manufacturer of Clarius AI?

Clarius Mobile Health Corp. filed the 510(k) submission for Clarius AI (K222406).

What is the FDA product code for Clarius AI?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Clarius AI?

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

Does Clarius AI use AI or machine learning?

Yes. Clarius AI (K222406) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Clarius AI?

LVivo Software Application (K200232).

Who can help prepare an FDA 510(k) submission like Clarius AI?

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 Clarius AI 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.

Clarius AI

K222406 · Clarius Mobile Health Corp. · QIH · Jan 23, 2023 · Radiology

Device Facts

Record ID	K222406
Device Name	Clarius AI
Applicant	Clarius Mobile Health Corp.
Product Code	QIH · Radiology
Decision Date	Jan 23, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K222406 · Jan 23, 2023	Clarius AI	Clarius Mobile Health Corp.	Retrospective analysis of anonymized ultrasound images from clinical partners in outpatient clinics	Retrospective analysis of clinical ultrasound images was used to verify that the device's automated tendon thickness measurements and segmentation masks were non-inferior to manual measurements performed by expert clinicians.	Retrospective analysis; Clinical ultrasound images; Tendon thickness measurement; Verification study

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Verification testing of Clarius AI; Retrospective analysis	Ultrasound images of Achilles' tendons, plantar fascia, and patellar tendons; Sample Size: 2,503 ultrasound images/frames from 73 subjects; Number of Sites: Not specified (collected by clinical partners in outpatient clinics)	Manual measurements performed by licensed clinicians with musculoskeletal ultrasound experience	Tendon thickness measurement accuracy and segmentation mask alignment

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Tendon thickness measurement	U-Net with MobileNetV2 backbone	Difference between auto-measurements and manual measurements no greater than clinically significant margin (20%)	Mean difference 0.03% (95% CI -0.05% to -0.01%); p-value 9.0 x 10^-7	20,287 images from 73 subjects; images captured in-house and by clinical partners.	1 (clinical scientist)	Retrospective analysis of 2,503 ultrasound images from 73 subjects.	>1 (licensed clinicians)

Indications for Use

Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L 7 and L15). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical iudgment.

Device Story

Clarius AI is a software application integrated into the Clarius Ultrasound Scanner system; it processes real-time ultrasound images of musculoskeletal structures (Achilles' tendon, plantar fascia, patellar tendon). The device uses an AI image segmentation algorithm to identify tendon boundaries; it displays a transparency overlay on the ultrasound image. When imaging is paused, the software calculates the greatest tendon thickness in pixels and automatically places measurement calipers; it outputs the thickness in millimeters. The clinician reviews the output and may manually adjust the calipers. The device is used in clinical settings (hospitals, clinics) by trained healthcare professionals. It assists in clinical management by providing quantitative measurements; the clinician retains ultimate responsibility for clinical decisions. The device benefits patients by providing standardized, semi-automated measurements of musculoskeletal structures.

Clinical Evidence

Bench testing and retrospective analysis only. Training dataset: 20,287 images. Validation study: 73 subjects, 2,503 images. Performance: 96% average Dice score, 94% mean IoU for tendon segmentation. Verification testing compared AI auto-measurements to expert manual measurements; results showed non-inferiority (p=9.0 x 10^-7) with an equivalence margin of 20%. Mean difference between differences was 0.03% (95% CI: -0.05 to -0.01).

Technological Characteristics

Ultrasound image processing software; utilizes non-adaptive machine learning (U-Net with MobileNetV2 backbone). Operates on Clarius Ultrasound App (iOS/Android) using L7 and L15 transducers. Connectivity: Clarius Cloud storage. Standards: IEC 62304 (software lifecycle), ISO 14971 (risk management), NEMA PS 3.1-3.20 (DICOM), IEC 62366-1 (usability).

Indications for Use

Indicated for adult patients; intended for use by trained healthcare professionals to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by Clarius L7 and L15 scanners.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

LVivo Software Application (K200232)

Reference Devices

CoLumbo (K220497)
Al-Rad Companion (Musculoskeletal) (K193267)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". Clarius Mobile Health Corp. Agatha Szeliga Director, Regulatory Affairs 130-2985 Virtual Way Vancouver, British Columbia V5M 4X7 Canada Re: K222406 January 23, 2023 Trade/Device Name: Clarius AI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: December 16, 2022 Received: December 21, 2022 Dear Agatha Szeliga: 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 (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 located 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. 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 {1}------------------------------------------------ 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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). Sincerely, Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222406 Device Name Clarius AI #### Indications for Use (Describe) Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L 7 and L15). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical iudgment. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:inline-block"> </div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block"> </div> 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}------------------------------------------------ This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92. | Subject Device Trade Name: | Clarius Al | |-----------------------------|--------------------------------------------------| | Subject Device Model: | MSK | | Device Classification Name: | Automated Radiological Image Processing Software | ## Regulation Number, Name and Product Code: | Regulation Number | Regulation Name | Product Code | |-------------------------------|-------------------------------------------------------------------------------------|--------------| | 21 CFR § 892.2050 | Medical Image Management and Processing System | QIH | | FDA 510(k) Review Panel: | Radiology | | | Classification: | Class II | | | Manufacturer: | Clarius Mobile Health Corp. 130-2985 Virtual Way Vancouver, BC V5M 4X7 Canada | | | Contact Name: | Agatha Szeliga Director, Regulatory Affairs agatha.szeliga@clarius.com | | | Date 510(k) Summary Prepared: | December 15, 2022 | | ## Predicate Device Information: | Device Trade Name: | LVivo Software Application | |-----------------------------|--------------------------------------------------| | 510(k) Reference: | K200232 | | Manufacturer Name: | DiA Imaging Analysis Ltd | | Regulation Name: | Medical Image Management and Processing System | | Device Classification Name: | Automated Radiological Image Processing Software | | Product Code(s): | QiH | | Regulation Number: | 21 CFR § 892.2050 | | Regulatory Class: | Class II | Note: The predicate device has not been subject to a design-related recall. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Clarius Ultrasound logo. The logo consists of an orange icon that resembles three concentric letter C's, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal. ## Reference Device #1 Information: | Device Trade Name: | CoLumbo | |-----------------------------|--------------------------------------------------| | 510(k) Reference: | K220497 | | Manufacturer Name: | Smart Soft Healthcare AD | | Regulation Name: | Medical Image Management and Processing System | | Device Classification Name: | Automated Radiological Image Processing Software | | Product Code(s): | QIH | | Regulation Number: | 21 CFR § 892.2050 | | Regulatory Class: | Class II | ## Reference Device #2 Information: | Device Trade Name: | Al-Rad Companion (Musculoskeletal) | |-----------------------------|-------------------------------------| | 510(k) Reference: | K193267 | | Manufacturer Name: | Siemens Medical Solutions USA, Inc. | | Regulation Name: | Computed tomography x-ray system | | Device Classification Name: | Computed tomography x-ray system | | Product Code(s): | JAK | | Regulation Number: | 21 CFR § 892.1750 | | Regulatory Class: | Class II | ## Device Description Clarius AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (Al), including non-adaptive machine learning algorithms, and is incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering in musculoskeletal (MSK) ultrasound imaging applications. Clarius Al (MSK model) is intended for use by trained healthcare practitioners for non-invasive measurements of ultrasound data from musculoskeletal (MSK) ultrasound imaging acquired by the Clarius Ultrasound Scanner system using an artificial intelligence (AI) image segmentation algorithm. Clarius AI (MSK model) is intended to semi-automatically place adjustable calipers and provide supplementary information to the user regarding tendon thickness measurements (i.e., foot/plantar fascia, ankle/Achilles' tendon, knee/patellar tendon). Clarius Al is intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Al is indicated for use in adult patients only. During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (e.g., foot, ankle, knee), in which the Clarius Al will engage to segment the correlating tendon. Clarius Al analyzes ultrasound images in real-time and outputs probabilities for each pixel within the image for determination of the particular tendon thickness. The combination of all the pixels meeting a programmed threshold will render an overlay being displayed on top of the ultrasound image with a pre-programmed transparency so that the ultrasound greyscale is still visible. Once the user has obtained the best view, imaging can be manually paused, in which the Clarius Al will further analyze the tendon segmentation to determine the greatest thickness, in number of {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three concentric letter C's, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal. pixels, and subsequently place two measurement calipers that correspond to the top and bottom of the tendon at its thickest region, outputting a value in millimeters. The user can then manually alter the measurement calipers to make any necessary adjustments if desired. Clarius Al does not perform any functions that could not be accomplished manually by a trained and qualified user. Clarius AI (MSK model) is incorporated into the Clarius App software and is intended for use with the following Clarius Ultrasound Scanner system transducers (previously 510(k)-cleared in K180799, K192107, and K213436): | Clarius Ultrasound Transducers | L7 and L15 | |--------------------------------|---------------------------------------------------------------------------------------------------| | Clarius App Software | Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android | ## Indications for Use for Clarius AI (MSK) Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L7 and L15). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical iudgment. ## Comparison of the Subject Device and Legally Marketed Devices for Demonstration of Substantial Equivalence The following table provides a comparison of the subject device, Clarius Al, to the predicate device and reference devices. A comparison of the subject device to the predicate and reference devices shows that the subject device has similar indications for use, is based on a similar Al algorithm, and provides automated radiological image processing with segmentation and measurement of anatomical structures, comparable to the legally marketed devices referenced herein. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three concentric letter C's, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal. ## Table 1 - Comparison of the Subject Device to the Legally Marketed Devices | Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE (if subject device differs from predicate device) | |---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Clarius Al | LVivo Software Application | Columbo | Al-Rad Companion (Musculoskeletal) | | | 510(k) Holder/ Manufacturer | Clarius Mobile Health Corp. | DiA Imaging Analysis Ltd | Smart Soft Healthcare AD | Siemens Medical Solutions USA, Inc. | Not applicable | | Submission Reference | Current Submission | K200232 | K220497 | K193267 | Not applicable | | Product Code(s) | QIH | QIH | QIH | JAK | Same as predicate device and reference device #1 | | Device Classification Name | Automated Radiological Image Processing Software | Automated Radiological Image Processing Software | Automated Radiological Image Processing Software | Computed tomography x-ray system | Same as predicate device and reference device #1 | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1750 | Same as predicate device and reference device #1 | | Regulation Name | Medical Image Management and Processing System | Medical Image Management and Processing System | Medical Image Management and Processing System | Computed tomography x-ray system | Same as predicate device and reference device #1 | | Intended Use | Non-invasive processing of ultrasound images using automatic image segmentation and measurement of anatomical structures utilizing artificial intelligence algorithms. | Non-invasive processing of ultrasound images using automatic image segmentation and measurement of anatomical structures utilizing artificial intelligence algorithms. | Non-invasive processing of MR images using automatic image segmentation and measurement of anatomical structures utilizing artificial intelligence algorithms. | Non-invasive processing of CT images using automatic image segmentation and measurement of anatomical structures utilizing artificial intelligence algorithms. | Same as predicate device and similar to reference devices | | Indications for Use | Clarius Al is intended for use by trained healthcare professionals to semi- automatically place | LVivo platform is intended for non- invasive processing of ultrasound images to detect, measure, and | Columbo is an image post-processing and measurement software tool that provides quantitative | Al-Rad Companion (Musculoskeletal) is an image processing software that provides quantitative and | Clarius Al indications for use are similar to the predicate device's indications for use as both devices are | | Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE (if subject device differs from predicate device) | | | Clarius Al | LVivo Software Application | CoLumbo | Al-Rad Companion (Musculoskeletal) | | | | calipers for non-invasive anatomical measurements on ultrasound data acquired by the Clarius Ultrasound Scanner. | calculate relevant medical parameters of structures and function of patients with suspected disease. | spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements: -Feature segmentation; -Feature measurement; Threshold based labeling of out of range measurement; and -Export of measurement results to a written report for user's review, revise and approval. CoLumbo does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to | qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of musculoskeletal disease. It provides the following functionality: -Segmentation of vertebrae -Labelling of vertebrae -Measurements of heights in each vertebra and indication if they are critically different -Measurement of mean Hounsfield value in volume of interest within vertebra. Only DICOM images of adult patients are considered to be valid input. | indicated for non-invasive processing of ultrasound data/ images for measurements of anatomical structures. | | Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE (if subject device differs from predicate device) | | | Clarius Al | LVivo Software Application | CoLumbo | Al-Rad Companion (Musculoskeletal) | | | | | | more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for confirming/ modifying settings, reviewing and verifying the software- generated measurements, inspecting out-of- range measurements, and approving draft report content using their medical judgment and discretion. The device is intended to be used only by hospitals and other medical institutions. Only DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are considered to be valid input. Columbo does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post- | | | | Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE (if subject device | | | Clarius Al | LVivo Software Application | CoLumbo | Al-Rad Companion (Musculoskeletal) | differs from predicate device) | | Radiological application/ Supported modality | Ultrasound | Ultrasound | operational complications, scoliosis, tumors, infections, fractures. | CT | Same as predicate device | | Principle of Operation/ Technology | Ultrasound image processing software implementing artificial intelligence including non-adaptive machine learning algorithms trained with clinical and/or artificial data intended for non- invasive segmentation and measurements of ultrasound data. | Ultrasound image processing software implementing artificial intelligence including non-adaptive machine learning algorithms trained with clinical and/or artificial data intended for non- invasive segmentation and measurements of ultrasound data. | Radiological image processing software implementing artificial intelligence including non-adaptive machine learning algorithms trained with clinical and/or artificial data intended for non- invasive segmentation and measurements of MR data | Radiological image processing software implementing artificial intelligence including non-adaptive machine learning algorithms trained with clinical and/or artificial data intended for non- invasive segmentation and measurements of CT data | Same as predicate device | | Segmentation | Yes - Segmentation of anatomical structures (tendons) | Yes - Segmentation of anatomical structures (LV, RV, bladder) | Yes - Segmentation of anatomical structures (spinal vertebrae) | Yes - Segmentation of anatomical structures (spinal vertebrae) | Similar to predicate device and reference devices | | Measurement | Yes - Measurement of anatomical structures (tendons) | Yes - Measurement of anatomical structures (LV, RV, bladder) | Yes - Measurement of anatomical structures (spinal vertebrae) | Yes - Measurement of anatomical structures (spinal vertebrae) | Similar to predicate device and reference devices | | Al Algorithm | Image segmentation, anatomical identification, and measurement utilizing the machine learning- based algorithm Exception U-Net | Image segmentation for border detection. Algorithm combines image processing and Deep Learning Neural Network for analysis. | Deep Convolutional Image-to-Image Neural Network | 3D Deep Image-to- Image Network | Similar to predicate device and reference devices | | Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE (if subject device differs from predicate device) | | | Clarius Al | LVivo Software Application | CoLumbo | Al-Rad Companion (Musculoskeletal)…

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