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The ConforMIS™ Unicondylar Knee System is intended for use in Patients with:

• joint impairment due to osteoarthritis or traumatic arthritis of the knee
• Previous tibial condyle or plateau fracture, creating loss of function
• valgus or varus deformity of the knee
  The ConforMIS™ Unicondylar Knee System is for use with cement.

The ConforMIS Unicondylar Knee System is a device developed from patient CT scans to replace one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and allows internal/external rotation between the femoral and tibial components. Movement is limited by the ligaments and other soft tissues surrounding the device. The device is designed to conform to the patient's anatomy as closely as possible based on the CT scans.

The provided document describes the ConforMIS™ Unicondylar Knee Repair System, a custom-designed knee implant. However, it does not contain specific acceptance criteria, performance data from a clinical study, or details about the methodology of such a study.

Here's an breakdown of the information that is available and what is missing based on your request:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not reported in the document. The document states: "Performance Data: Non-clinical Performance and Conclusions: Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence. Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence."

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

• Not Applicable. No clinical test set data is provided.

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)

• Not Applicable. No clinical test set data is provided, and therefore no ground truth establishment based on expert review.

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

• Not Applicable. No clinical test set data is provided.

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 physical knee implant, not an AI/software device intended for diagnostic interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No clinical study involving ground truth establishment is described.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. It is "developed from patient CT scans to replace one compartment of the knee condyles" and "designed to conform to the patient's anatomy as closely as possible based on the CT scans." While patient CT scans are used for designing the individualized implant, this is not a "training set" in the context of an AI algorithm, and no sample size for such a set is mentioned.

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

• Not Applicable. As above, there is no "training set" in the AI sense for which ground truth would be established. The "ground truth" for the device design is the individual patient's anatomy derived from their CT scans.

Summary of the Study (as described in the document):

The document explicitly states: "Clinical data and conclusions are not necessary to demonstrate substantial equivalence." Instead, the submission relies on:

• Non-clinical Performance and Conclusions: "Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence." This refers to non-clinical (e.g., bench, mechanical) testing, but no specific results or acceptance criteria for this testing are provided.
• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through a comparison to legally marketed predicate devices (K033242, K033363, K033769). The ConforMIS™ Unicondylar Knee System is deemed substantially equivalent in terms of technological characteristics (design, production process, materials) and intended use.

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