Ortho AI

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Ortho AI LLC Jonathan Vigdorchik Orthopaedic Surgeon 155 East 76th Street Apt 2H New York, NY 10021 January 2, 2025 Re: K241696 Trade/Device Name: Ortho AI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: November 26, 2024 Received: November 27, 2024 Dear Jonathan Vigdorchik: 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" {1}------------------------------------------------ (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). 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 (OS) 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 medical devices and radiation-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-regulatory {2}------------------------------------------------ assistance/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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) K241696 Device Name Ortho Al Indications for Use (Describe) Ortho AI is an image-processing software indicated to assist in making measurements for a total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery. It is intended to assist in the measurement of x-ray images by measuring lengths, angles and position of implants relative to the bone structures of interest provided, that the points of interest can be identified from radiology images. The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. The software is not for primary image interpretation. The software is not for use on mobile phones. Intended patient population: Adult patients >=22 years old, with appropriate imaging, undergoing primary hip replacement, primary knee replacement, and lumbar spine surgery. Intended user population: orthopaedic surgeons who perform hip and knee replacement, and orthopaedic/neurosurgeons who perform lumbar spine surgery. 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." {4}------------------------------------------------ #### 510(k) Summary | Device Trade Name: | Ortho AI | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Ortho AI<br>155 East 76th Street Apt 2H<br>New York, NY 10021<br>Phone: 314-662-3222 | | Contact: | Jonathan Vigdorchik<br>Ortho AI LLC<br>155 East 76th Street<br>Apt 2H<br>New York, NY 10021<br>Phone: 314-662-3222<br>jonnyvmd@gmail.com | | Prepared By: | MCRA, LLC<br>803 7th St NW<br>Washington, DC 20001<br>Office: 202.552.5800 | | Date Prepared: | November 25, 2024 | | Device Trade Name: | Ortho AI | | Classification: | 892.2050 Medical image management and processing system | | Class: | Class II | | Product Code: | QIH | | Predicate Device: | KOALA - K192109 | | Classification: | 892.2050 Medical image management and processing system | | Class: | Class II | | Product Code: | QIH | ### Indications for Use: Ortho AI is an image-processing software indicated to assist in making measurements for a total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery. It is intended to assist in the measurement of x-ray images by measuring lengths, angles and position of implants relative to the bone structures of interest, provided that the points of interest can be identified from radiology images. The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. The software is not for primary image interpretation. The software is not for use on mobile phones. {5}------------------------------------------------ Intended patient population: Adult patients >= 22 years old, with appropriate imaging, undergoing primary hip replacement, primary knee replacement, and lumbar spine surgery. Intended user population: orthopaedic surgeons who perform hip and knee replacement, and orthopaedic/neurosurgeons who perform lumbar spine surgery. ### Device Description: Ortho AI is a software as a medical device (SaMD) system that provides preoperative planning data for hip replacement surgery, knee replacement surgery, and lumbar spinal fusion surgery using AI/ML models that are semi-automated and interpretable. The software guides the user through a predetermined workflow that begins with the use of preoperative radiographic images as input to the software. As part of this initial preoperative workflow, the software places digital annotations on these preoperative images, which can be modified by the user (semi-automated). The software additionally includes functionality to store user, patient, and case information. ### Software/firmware input As a non-invasive software as a medical device (SaMD) system, Ortho AI requires, as input, preoperative radiographic images of the pelvis, knee, or spine. Input mages may be one of a large number of standard image formats that are supported (.jpg, .bmp, etc.), a DICOM image. The image can also be uploaded intraoperatively from a fluoroscopic c-arm via a direct cable connection. Images must be uploaded by a healthcare professional. ### Software/firmware output The software output will be an HTML page that displays the processed image in JPEG format. The output displays the measurements of angles and length of anatomical structures that are essential for preoperative planning for the anatomical site displayed in the image. The output can only be viewed by a healthcare professional. ### Software functions Ortho AI is a software-only device intended to be used by healthcare professionals for the preoperative and intraoperative planning of total hip replacement surgery, partial/total knee replacement surgery, or lumbar spine surgery. The software semi-automates templating/planning for surgery. In the standard of care pre-operative planning procedure, a healthcare provider templates manually or digitally on a radiograph by drawing lines, making angular measurements, and sizing implants using acetate or digital templates. The Ortho AI software will semi-automate the above listed tasks by taking a radiological image as input and delivering key measurements of the surgeon's interest through an AI algorithm. These landmarks are then editable by the user. | Feature | Subject Device | Predicate Device | Comparison | |--------------------------------------------|----------------------------------------------------|----------------------------------------------------|------------| | 510(k) Number | K241696 | K192109 | N/A | | Name | Ortho AI | IB Lab's KOALA<br>Software | N/A | | Classification<br>Name and<br>Product Code | System, Image<br>Processing,<br>Radiological (QIH) | System, Image<br>Processing,<br>Radiological (LLZ) | Same | ### Substantial Equivalence: {6}------------------------------------------------ | Runs on Server | Yes | Yes | Same | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Image input | JPEG, PNG, BMP,<br>DICOM | DICOM compliant<br>images collected in other<br>devices in either digitally<br>computed (CR) or<br>directly digital (DX)<br>formats. | Similar. The subject<br>device is validated to<br>additionally analyze other<br>standard image formats<br>and does not raise new<br>questions about safety or<br>effectiveness. | | Imaging<br>processing | Landmark detection, user<br>can edit landmark | Knee detection;<br>Landmark detection;<br>Joint space detection | Same | | Anatomical<br>Area | Knee, Hip, Lumbar Spine | Leg | Similar. The subject<br>device is intended to be<br>used on the knee, hip, and<br>lumbar spine while the<br>predicate device is only<br>for the leg. This<br>difference in specific<br>anatomic locations does<br>not raise new types of<br>questions for safety or<br>effectiveness. | | Measurement | Length and angle | Length and angle | Same | | Way of<br>Measurement | Semi-automatic (AI<br>driven) | Automatic (AI driven) | Similar. The subject<br>device requires the user<br>to review and edit the<br>device output as<br>necessary while the<br>predicate device does not<br>as a fully automatic<br>device. | | Intended User | Trained Professional | Trained Professional | Same | | Indications for<br>Use | Ortho AI is an image-<br>processing software<br>indicated to assist in<br>making measurements for<br>a total hip arthroplasty,<br>total knee arthroplasty,<br>and lumbar spine fusion<br>surgery.<br><br>It is intended to assist in<br>the measurement of x-ray<br>images by measuring<br>lengths, angles and<br>position of implants<br>relative to the bone<br>structures of interest,<br>provided that the points<br>of interest can be | IB Lab KOALA is a<br>radiological fully-<br>automated image<br>processing software<br>device of either computed<br>(CR) or directly digital<br>(DX) images intended to<br>aid medical professionals<br>in the measurement of<br>minimum joint space<br>width; the assessment of<br>the presence or absence<br>of sclerosis, joint space<br>narrowing, and<br>osteophytes based<br>OARSI criteria for these<br>parameters; and the<br>presence or absence of | The subject device<br>performs measurements<br>of lengths and angles on<br>hip, knee, and lumbar<br>spine images. The<br>predicate device performs<br>length and angle<br>measurements on leg<br>images. This difference in<br>specific anatomic<br>locations does not raise<br>new questions for safety<br>or effectiveness and<br>therefore does not induce<br>changes in the intended<br>use | {7}------------------------------------------------ | identified from radiology | radiographic knee OA | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | images. The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. The software is not for primary image interpretation. The software is not for use on mobile phones. Intended patient population: Adult patients >=22 years of age, with appropriate imaging, undergoing primary hip replacement, primary knee replacement, and lumbar spine surgery. Intended user population: orthopaedic surgeons who perform hip and knee replacement, and orthopaedic/neurosurgeon s who perform lumbar spine surgery. | based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in- lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians, and medical technicians. | ### Performance Testing Summary: Software Validation and Verification was performed. ### Acceptance Criteria and Sample size The overall aim was to achieve a Dice coefficient greater than 0.85 (Dice > 0.85). A test sample size of ≥ 150 samples and observing an effect size of ≥ 0.01370, we can be confident achieving a statistical power of ≥ 80%. Acceptance criteria for a mean Dice coefficient at a minimum of 0.85 for all algorithms and all connected domains. ### Model summary: Data independence: We ensured full data independence by adopting a patient-level partitioning process, where each patient contributed only a single x-ray image to the dataset, eliminating any risk of intersample dependencies or data leakage between the training, validation, and testing phases. {8}------------------------------------------------ Truthing process: 3 fellowship-trained ABOS board-certified orthopaedic surgeons with each greater than 10 years of experience, followed a 2+1 truthing process where two blinded orthopaedic surgeons reviewed each segmented image in the testing set and applied modifications. After the reviews from each blinded surgeon, a final senior-level surgeon adjudicator reviewed the modifications and added further modifications to the segmentations, if necessary. ### Hip model: - 1,367 images from 1,367 patients - - Average age: 62 - - Female: 52% - - Ethnicity: 78% white, 18% Black/African American, 1% Other (non-white), 3% Asian - ### Hip-spine model: - 4,836 images from 4,836 patients - - Average age: 62 - - Female: 61% - - -Ethnicity: 78% white, 18% Black/African American, 1% Other (non-white), 3% Asian # Knee model: - -4,536 images from 4,536 patients - Average age: 61 - - -Female: 52% - Ethnicity: 78% white, 18% Black/African American, 1% Other (non-white), 3% Asian - # Standalone algorithm testing Hip model: - LLD measurements within +/- 1.96mm of human measurement - - -Offset (global) within +/- 0.88mm of human measurement - SFP angle within +/- 1.05mm of human measurement - - Overall performance as measured by Dice coefficient shows all connected domains to be above our acceptance criteria of 0.85. - Subgroup analysis by x-ray machine also shows that all connected domains, across all x-ray machine types, to be above our acceptance criteria of 0.85. # Hip-spine model: - SS, SPT, APPt, PI, LL, PI-LL all within 2 degrees of human measurement - - No statistical difference between human vs. machine learning measurements - - Overall performance as measured by Dice coefficient shows all connected domains to be above our acceptance criteria of 0.85. - Subgroup analysis by x-ray machine also shows that all connected domains, across all x-ray machine types, to be above our acceptance criteria of 0.85. # Knee model: - LDFA , mPTA, aHKA, aJLOA all within 2 degrees of human measurement - - -No statistical difference between human vs. machine learning measurements {9}------------------------------------------------ - Overall performance as measured by Dice coefficient shows all connected domains to be above our acceptance criteria of 0.85. - Subgroup analysis by x-ray machine also shows that all connected domains, across all x-ray machine types, to be above our acceptance criteria of 0.85. ### Conclusion Ortho AI demonstrates substantial equivalence to the predicate device. The subject device has the same intended use and principles of operation; furthermore, it has similar indications and technological characteristics as its predicate device. The minor differences between subject and predicate device in indications do not alter the intended use of the subject device and do not raise new or different questions regarding its safety and effectiveness when used as labeled. Performance data demonstrate that the device performs as intended. Verification and validation testing, including the standalone software performance test, supports the safety of the device and demonstrates that Ortho AI performs as intended. Therefore, Ortho AI demonstrates substantial equivalence to the predicate device.