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The Synthes modified PFN is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The Long PFN is additionally indicated for pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) in both trochanteric and diaphyseal areas, long subtrochanteric fractures, proximal or distal non-unions and malunions and revision procedures.

Synthes modified PFN System is a cannulated intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. The following components make up the PFN system: proximal femoral nails, hip pins, femoral neck screws, locking bolts, and end caps. Synthes modified PFNs are available in lengths of 240 mm (short) and 340, 380, and 420 mm (long). The nails allow for both proximal and distal locking options. Synthes modified PFN System is manufactured from titanium alloy.

The provided text is a 510(k) Summary for the Synthes (USA) Proximal Femoral Nail System, concerning modifications to an existing device (K970097). This document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through a clinical trial or AI algorithm validation.

This document is a regulatory submission demonstrating substantial equivalence to a predicate device. It focuses on device description, intended use, and regulatory classification, not on detailed performance study results with specific acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as no such test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to seek FDA clearance for market entry based on substantial equivalence, not to present a detailed performance study against specific acceptance criteria.

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