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The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement for one of the following:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
2. Correction of varus, valgus or post traumatic deformity
3. Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
4. Ligament deficiencies
5. Tumor resections
6. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
7. Revision of previously failed total joint arthroplasty
8. Trauma
   This device is a single use implant.

The OSS Les Proximal Femoral Component is designed for use with Biomet's Oncology Salvage System. It may be used either for proximal femoral replacement with a diaphyseal segments and intramedullary stem or as part of a total femur replacement with a segmental distal femur component and the appropriate hinged knee components.
The OSS Les Proximal Femeral Component combines features of the three styles of Proximal Femoral Components contained in 510(k) K002757.

The provided document is a 510(k) premarket notification for a medical device (OSS Les Proximal Femoral Component) and a letter of substantial equivalence from the FDA. This type of document focuses on establishing equivalence to existing devices and does not typically include an acceptance criteria table, detailed study results for performance metrics, or information on AI/standalone algorithms, MRMC studies, or detailed ground truth methodologies that would be found in a clinical trial report or a performance study for novel devices.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an analysis based on the available information:

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

• Not applicable / Not provided. The document states "Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned." This suggests that the acceptance criteria are implicitly met by demonstrating "similar characteristics" to legally marketed predicate devices, rather than specific performance metrics against a predefined threshold. No specific performance metrics or acceptance criteria are listed.

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 / Not provided. No clinical or non-clinical test set data is described in a way that would allow for sample size determination or data provenance information.

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 / Not provided. No test set or ground truth establishment by experts is described.

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

• Not applicable / Not 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 document pertains to a mechanical orthopedic implant, not an AI or imaging device. No MRMC study or AI assistance is mentioned.

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

• Not applicable. This document pertains to a mechanical orthopedic implant, not an AI or algorithm-based device. No standalone algorithm performance is mentioned.

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

• Not applicable / Not provided. As no dedicated clinical study is described for the device, there is no mention of ground truth types for performance evaluation. The basis for clearance is "substantial equivalence" to predicate devices, which implies that the predicate devices' established safety and effectiveness serve as an indirect "ground truth" for the new device's acceptable performance.

8. The sample size for the training set

• Not applicable / Not provided. No training set for an algorithm is relevant or mentioned.

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

• Not applicable / Not provided. No training set or ground truth establishment for it is relevant or mentioned.

Summary derived from the document:

The document explicitly states: "Clinical Testing: None provided". It also mentions "Non-Clinical Testing: Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned."

This indicates that the device's acceptance was based on a demonstration of substantial equivalence to previously cleared predicate devices (K002757) through engineering analysis, rather than through a new clinical study with specific acceptance criteria and performance outcomes. The "acceptance criterion" in this context is that the device is "substantially equivalent" to predicate devices in terms of materials, surface finishes, processing, and intended use, and that "no new risks are envisioned."

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