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The Overture Orthopaedics Patellofemoral System is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The Overture Orthopaedics Patellofemoral System is comprised of trochlear implants, and a set of ancillary instruments. The trochlear implants are titanium and feature a polished articulating surface with a titanium nitride (TiN) coating. The patellar implants are cross-linked ultra high molecular weight polyethylene (UHMWPE) and feature a titanium pin for X-ray visualization. The trochlear and patellar implants utilize cemented pegs for immediate fixation. The trochlear implants also feature porous titanium bone-contacting surfaces.

The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. The trochlear implants are offered in long and round geometries. The long implants are offered in lengths ranging 25-40mm and widths ranging 20-35mm. The round trochlear implants are offered in diameters ranging 20-35mm. The patellar implants are offered in a domed geometry in diameters of 25mm and 30mm.

The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.

This document is a 510(k) summary for the Overture Orthopaedics Patellofemoral System. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a medical implant, specifically a patellofemoral system for knee joint arthroplasty. The acceptance criteria and the study that proves the device meets them are described in terms of performance testing for mechanical characteristics, not in terms of diagnostic accuracy or reader performance as the format of the request assumes.

Here's a breakdown of the requested information based on the provided document:

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

   The document does not explicitly list acceptance criteria in a quantitative table with corresponding reported performance for each criterion. Instead, it lists the types of performance testing conducted to demonstrate substantial equivalence. The document states:

   "In summary, rationales and mechanical testing of the Overture Orthopaedics Patellofemoral System indicated there are no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate."

   This implies that the acceptance criterion for each test was likely "demonstrates substantial equivalence to the predicate device" or "meets established rationales without new risks." The reported device performance is summarized as having met this overall criterion.

   Acceptance Criteria (Implied)	Reported Device Performance
   Demonstrate substantial equivalence to predicate device in terms of:
   - Patellofemoral Contact Area and Contact Stress	Testing indicated no new risks and substantial equivalence.
   - Patellofemoral Constraint	Testing indicated no new risks and substantial equivalence.
   - Range of Motion	Testing indicated no new risks and substantial equivalence.
   - Fatigue Strength	Rationale adopted, indicating substantial equivalence.
   - Wear	Rationale adopted, indicating substantial equivalence.
   - Additive Manufacturing Characteristics	Rationale adopted, indicating substantial equivalence.
   - Characterization of UHMWPE	Rationale adopted, indicating substantial equivalence.
   - Characterization of Porous Coating	Rationale adopted, indicating substantial equivalence.
   - Modified Metallic Surfaces	Rationale adopted, indicating substantial equivalence.
   Absence of new risks	No new risks indicated.

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

   The document describes "bench testing" and "cadaveric validation lab." It does not specify sample sizes for these tests (e.g., how many implants were tested for fatigue, how many cadavers were used). It also does not mention country of origin or whether the data was retrospective or prospective, as these terms are generally not applicable to bench and cadaveric testing of medical implants.

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)

   This question is not applicable to the type of device and testing described. The "ground truth" for mechanical performance tests is typically measured physical properties, not expert consensus on medical images or diagnoses.

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

   This question is not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation (e.g., by radiologists), not for bench testing of medical implants.

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

   This question is not applicable. An MRMC study with human readers and AI assistance is relevant for diagnostic AI devices. The Overture Orthopaedics Patellofemoral System is a surgical implant undergoing mechanical and material testing, not an AI diagnostic tool.

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

   This question is not applicable. The device is a physical implant, not an algorithm.

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

   For the performance testing mentioned (e.g., contact area, stress, constraint, fatigue), the "ground truth" would be physical measurements and engineering data obtained from standardized mechanical tests or cadaveric studies. The basis for comparison is the performance of the legally marketed predicate device.

8. The sample size for the training set

   This question is not applicable. There is no concept of a "training set" for a physical medical implant device in the context of its mechanical performance testing.

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

   This question is not applicable for the same reason as point 8.

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