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These devices are fracture fixation devices comprised of femoral and tibial nails and the related accessories such as locking screws, compression screws, end caps, condyle screws, and a condyle screw nut. The S2 tibial nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The S2 femoral nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the femur.

S2 Tibial Nail: The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked. The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: Open and closed tibial fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Nonunion and malunion.

S2 Femoral Nail: The S2 Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Fractures distal to a hip joint, Nonunions and malunions.

This Traditional 510(k) submission is being supplied to the US FDA to include targeter devices as accessories to the S2 Nail System that was cleared under K032579.

Here's a breakdown of the acceptance criteria and study information for the S2 Nail System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test set: Not explicitly stated as a numerical sample size. The text mentions a "human cadaveric lab." For the bench testing, no sample size is provided.
   • Data provenance: Not specified beyond "human cadaveric lab." No country of origin is mentioned, and the nature of the cadaveric lab (retrospective or prospective) isn't detailed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of experts: Not explicitly stated. The testing was conducted in a "human cadaveric lab," which implies involvement of individuals with surgical or anatomical expertise, but their exact number and qualifications are not provided.
   • Qualifications of experts: Not explicitly stated.

3. Adjudication method for the test set:

   • Not applicable as the testing described is primarily observational (cadaveric lab, bench testing) rather than involving subjective interpretation requiring adjudication.

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 medical implant, not an AI diagnostic tool, so such a study would not be relevant.

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

   • No standalone algorithm-only performance study was done. This device is a physical implant, not a software algorithm.

6. The type of ground truth used:

   • For the cadaveric lab, the "ground truth" was the successful, complication-free implantation of the device as assessed by the operators.
   • For the mechanical tests, the "ground truth" was adherence to engineering performance standards demonstrating that modifications did not worsen performance.

7. The sample size for the training set:

   • Not applicable. This submission is for a physical medical device (intramedullary nail system), not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an AI algorithm was used.

Summary of the Study:

The provided document describes non-clinical testing performed for the S2 Nail System to support its substantial equivalence to predicate devices. This testing did not involve clinical trials or studies related to AI or diagnostic performance. Instead, it focused on:

• Cadaveric Study: Implantation of the S2 nails (with targeters) into human cadavers to ensure the devices could be used as intended without complications. This served as a practical demonstration of functionality.
• Mechanical/Bench Testing: Evaluation of modifications made to the existing nail adapter to ensure these changes did not negatively impact the product's performance or introduce new risks.

The conclusion drawn from these tests was that the S2 Nail System, including the new targeter devices, is substantially equivalent to the predicate devices and performs as intended. Clinical testing was explicitly stated as "not required for this submission."

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