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The ConforMIS, Inc., BiCompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as a unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to:

• painful joint disease due to osteoarthritis, traumatic arthritis or . rheumatoid arthritis of the knee
• post traumatic loss of joint function .
• . failed osteotomies, hemiarhtoplasties and unicondylar implants.
  The BiCompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofcmoral areas have been affected by one or more of these conditions.
  The ConforMIS, Inc., BiCompartmental Knee Repair System is intended only for use with bone cement.

The ConforMIS, Inc., BiCompartmental Knee Repair System is a femorotibial semi-constrained total knee implant. The design of the product incorporates a bone preserving approach, with minimal bone resection, for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. It is intended for use in those patients whose condition cannot be appropriately and effectively addressed using a device that treats only a single knee compartment (i.e. a unicondylar or patellofemoral prosthesis), when the medial or lateral condyle and the patellofemoral regions are affected. Using patient imaging (either CT or MRI scans), a patient specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. The device is manufactured from cobalt chromium molybdenum alloy (ASTM-F-1537) from data obtained from images of the patient's individual geometry obtained using either CT or MRI scans. The tibial and patellar components are manufactured from Ulta-High Molecular Weight Polyethylene ("UHMWP" ASTM-F-648) The ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface. Off the Shelf (OTS) software is utilized to produce the surface Subsequently, Solid Works OTS software is used to create the design. ConforMIS, Inc., Implant Engineering Drawing. The BiCompartmental Knee Repair System is intended for use in conjunction with the tibial components of the ConforMIS Unicondylar Knee Replacement System and the patellofemoral components of the ConforMIS Total Knee Repair System.

The provided text is a 510(k) Summary for the ConforMIS, Inc. BiCompartmental Knee Repair System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study that establishes acceptance criteria and proves the device meets those criteria through performance metrics.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to performance testing against specific acceptance criteria, which is not the primary purpose of a 510(k) substantial equivalence submission for this type of device.

Here's a breakdown of what can and cannot be derived from the provided text:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. The document states that the device is "substantially equivalent to FDA-approved predicate devices with regard to indications for use and technological characteristics." It does not present specific acceptance criteria (e.g., in terms of biomechanical performance, wear rates, etc.) or report detailed performance data against such criteria. The "performance" assessment is based on comparison to predicate devices, not on a standalone performance study with defined acceptance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Cannot be provided. This document does not describe a clinical or performance test set. It refers to patient imaging (CT or MRI scans) being used to design patient-specific implants, but this is part of the manufacturing process, not a test set for evaluating the device's overall performance against acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Cannot be provided. There is no mention of a test set with ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a knee implant, not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a knee implant. While "ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface," this software is part of the design and manufacturing process, not a standalone diagnostic algorithm whose performance would be assessed in this manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Cannot be provided. There is no mention of ground truth as part of a performance study.

8. The sample size for the training set:

• Cannot be provided. The document refers to "patient imaging (either CT or MRI scans)" being used to design the implant, suggesting individual patient data for custom manufacturing, not a "training set" in the context of an AI/ML algorithm development.

9. How the ground truth for the training set was established:

• Cannot be provided. No training set or ground truth establishment is described.

Summary of what can be extracted related to the device:

The ConforMIS, Inc. BiCompartmental Knee Repair System is a Class II medical device (NPJ) intended for use in patients with severe knee joint pain and disability due to conditions like osteoarthritis, traumatic arthritis, or rheumatoid arthritis, where a single-compartment prosthesis is insufficient. It is a patient-specific implant designed using CT or MRI scans of the patient's knee. The device is manufactured from cobalt chromium molybdenum alloy, with tibial and patellar components from Ultra-High Molecular Weight Polyethylene and is intended for use with bone cement.

The 510(k) submission demonstrates substantial equivalence to predicate devices (listed in the table in section {1}) in terms of "indications for use and technological characteristics." The document states:

• "The technological characteristics of the ConforMIS, Inc., BiCompartmental Knee Repair System are substantially equivalent to those of the cited predicate orthonedic devices."
• "The image analysis is identical to that used for the Imaging Therapeutics Interpositional Device (iPD) and the ConforMIS Unicondylar Implant."
• "This device is equivalent in terms of design process, materials, production process, and equipment."

The regulatory path chosen for this device (510(k) substantial equivalence) means that the testing and validation focus on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo performance data against a set of newly defined acceptance criteria. The FDA's letter (Section {4} and {5}) confirms the substantial equivalence determination, allowing the device to be marketed.

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