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Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

Synthes TFN System consists of a cannulated femoral nail, a cannulated helical blade and a cannulated nail end cap. Synthes Helical Blades will be available in three additional lengths, 75 mm, 125 mm, and 130 mm.

The provided text describes a 510(k) premarket notification for the "Synthes Trochanteric Fixation Nail (TFN) System, additional Helical Blades." This submission aims to demonstrate substantial equivalence to a predicate device, not to establish a new performance benchmark for a novel device through a clinical study with acceptance criteria.

Therefore, the document does not report acceptance criteria or a study proving that the device meets such criteria in the way medical device AI performance studies typically do. This is a regulatory filing for a physical medical device (an intramedullary fixation rod system) and its accessories, not a software or AI-based diagnostic tool.

Based on the provided text, the device is being cleared based on substantial equivalence to a predicate device, not on specific performance metrics established through a clinical trial or algorithm-only study.

Consequently, I cannot provide the requested information as it is not present in the given document.

To directly answer your numbered points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable/Not provided. The submission is for substantial equivalence to a predicate device, not demonstrating performance against specific numerical acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable/Not provided. No test set or data provenance for a performance study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not 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/Not provided. This is a physical device, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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