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The T2 Femoral Nail System is a fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. The T2 Femoral Nail System is intended to provide strong and stable fixation with minimal soft tissue irritation. This device is intended to provide fixation not as a substitute for normal intact bone and tissue.

The T2 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 hip joint
• Nonunions and malunions

The T2 Femoral nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail is inserted into the femoral canal using either a retrograde or antegrade surgical approach. The T2 Femoral Nail is currently available in diameters ranging from 8 to 15 mm and lengths ranging from 140 to 480 mm. Additional sizes will offer 16 and 17 mm diameters.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the T2 Femoral Nail, formatted as requested.

Introduction:

The provided document describes a 510(k) submission for modifications to the T2 Femoral Nail system, specifically the introduction of larger diameters (16 and 17 mm). The submission asserts that these modifications do not alter the intended use, material, or operational principles of the previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The document implicitly defines the acceptance criteria as demonstrating that the modified device (T2 Femoral Nail with 16 and 17 mm diameters) maintains at least equivalent safety and effectiveness to its predicate devices.

Study Details:

The provided text describes a study that was performed to demonstrate the substantial equivalence of the modified T2 Femoral Nail.

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

   • Sample Size: Not explicitly stated as a numerical count of individual devices. It refers to "worst case predicate T2 Femoral Naily equivalent subject devices" and "the new 16 and 17mm diameter sizes." This implies a limited number of samples representing these specific configurations were tested.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The testing would have been conducted by Howmedica Osteonics Corp. or a contracted lab. It is inherently retrospective in the sense that it evaluates the modified device against pre-existing predicate devices.

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

   • Not applicable/Not mentioned. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical trials) where expert consensus is needed to define a "ground truth" for diagnostic accuracy. For a mechanical device, performance is typically measured against engineering specifications and industry standards, not expert-established "ground truth." The "ground truth" here is the expected mechanical performance and safety profile, established through engineering principles.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts. For mechanical testing, results are objective measurements and do not require expert adjudication in this manner.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI systems on human performance, often in diagnostic or imaging contexts. The T2 Femoral Nail is a mechanical implant, and the study described focuses on its physical properties and safety, not on human interpretation or AI assistance.

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

   • Yes, essentially a "standalone" performance evaluation was done for the device itself. The study focused purely on the mechanical properties and engineering analysis of the T2 Femoral Nail with the new diameters. There is no algorithm or human-in-the-loop component in this context. The device's performance was evaluated based on its inherent physical characteristics.

6. The type of ground truth used:

   • Engineering Principles, Mechanical Performance Standards, and Predicate Device Performance Data: The "ground truth" for this study is effectively the established safety and effectiveness profile of the predicate devices and general mechanical engineering principles applied to medical implants. The new devices must meet or exceed these established benchmarks.

7. The sample size for the training set:

   • Not applicable/Not mentioned. In the context described, there is no "training set" in the machine learning sense. The device's design is based on established engineering principles and prior device iterations, not on training data for an algorithm.

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

   • Not applicable. There is no training set mentioned or implied in the context of this mechanical device submission.

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