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The S2TM Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

This Special 510(k) submission is intended to address a material modification and a design modification of the T2™ Recon Nail System to create the subject device, which is referred to as the S2TM Recon Nail System. The material modification involves changing the material from Titanium alloy to Stainless Steel with design changes based on the S2™ Femoral and T2TM Recon Nails. There is no change in intended use for the modified device when compared to the previously cleared device.

The provided text describes a Special 510(k) submission for the S2™ Recon Nail System, which is a fracture fixation device. The submission aims to demonstrate substantial equivalence to a predicate device, the T2™ Recon Nail System, after a material and design modification.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:
   The document does not specify a "test set" in terms of patient data. The study mentioned is "mechanical testing" of the device itself. No details are provided regarding the sample size of tested components or the provenance of any data beyond that it relates to the physical device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The study involved mechanical testing of the device, not an evaluation requiring expert consensus on a clinical test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are relevant for studies involving human judgment or interpretation, which is not the case for the mechanical testing described.

4. 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:
   No MRMC comparative effectiveness study was done. This device is a physical medical implant (intramedullary nail), not an AI-assisted diagnostic or therapeutic tool for which such a study would be relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical implant, not an algorithm. The "standalone" assessment was mechanical testing of the device itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the mechanical testing, the "ground truth" would be engineering specifications and performance benchmarks derived from the predicate device. The text explicitly states, "comparable mechanical properties to the predicate components," implying the predicate's performance serves as the benchmark.

7. The sample size for the training set:
   Not applicable. This device is a physical medical implant, not a machine learning model, so there is no concept of a "training set" in this context.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set mentioned.

Summary of the Study:

The study proving the device meets the acceptance criteria was a mechanical testing comparison. The S2™ Recon Nail System underwent mechanical testing to demonstrate that its properties are comparable to those of the predicate device, the T2™ Recon Nail System. This mechanical equivalence was sufficient to establish "substantial equivalence" for the purpose of the 510(k) submission, confirming that the material and design modifications did not negatively impact the device's functional performance relative to the legally marketed predicate. The exact parameters of the mechanical tests (e.g., torsion, bending, fatigue strength) and their specific numerical acceptance criteria are not detailed in the provided text, but the conclusion is that "comparable mechanical properties" were achieved.

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