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The replacement of the patellofemoral joint with the KNEETEC PFJ device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint:

• Serious degenerative arthritis of the patellofemoral joint,
• Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction,
• Patellofemoral dislocation (dysplastic or other origin),
• Post-traumatic arthritis (patellar fracture),

The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only.

When used in association with the KNEETEC PFJ prosthesis, the patellar component of the HLS KNEETEC has the above mentioned indications for use.

The Kneetee PFJ is a semiconstrained resecting prosthesis intended for replacement of the patellofemoral joint. The prosthesis consists of two components, both for cemented use only: a femoral implant and a patella. The patella of the knee joint may be resurfaced with the HLS KNEETEC patellar component and a substantially equivalent in K094013) or KNEETEC PFJ patellar implant.

This document is a 510(k) premarket notification for the KNEETEC PFJ and HLS KNEETEC patellar component, which are patellofemoral knee prostheses. A 510(k) submission demonstrates that a new device is substantially equivalent to a legally marketed predicate device. This process does not typically involve clinical studies with human subjects or AI performance evaluations as described in your request. Instead, it relies on demonstrating equivalence through non-clinical (engineering) testing and comparison of technological characteristics.

Therefore, many of the requested categories are not applicable to this type of submission.

Here's an analysis based on the provided text:

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

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

• Sample size for test set: Not applicable in the context of a 510(k) for this type of device. The "test set" here refers to the actual physical devices undergoing non-clinical engineering tests (e.g., specific components for contact area, pressure, subluxation force). The document states "The following non-clinical testing has been performed on the smallest components of the ranges (worst case)." This implies a limited number of physical prototypes or manufactured components were tested, focusing on the worst-case scenario (smallest size).
• Data provenance: Not explicitly stated, but these were engineering studies performed by the manufacturer, Tornier (based in France for regulatory affairs contact, and USA for applicant). This is not data from human patients.
• Retrospective or prospective: Not applicable, as this refers to engineering tests, not clinical data collection.

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. Ground truth as typically understood for AI devices (e.g., expert consensus on medical images) is not relevant here. The "truth" in this context is established by engineering standards and measurements.

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

Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or diagnoses, not for engineering performance tests.

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 prosthesis, not an AI or imaging device that would involve human readers or AI assistance in diagnosis.

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

Not applicable. This is a physical medical device (implant), not an algorithm or software.

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

The "ground truth" for the non-clinical testing was based on engineering standards and direct physical measurements. The performance of the KNEETEC PFJ was compared against the measured performance of predicate devices based on parameters like contact area, contact pressure, and subluxation force.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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