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The T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

The subject device is indicated for 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 distal to a hip joint ●
• Nonunions and malunions
• Reconstruction

The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar is available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm.

The provided text describes a 510(k) premarket notification for the "T2 Supracondylar Nail System." This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. It does not typically contain detailed studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies (MRMC) in the way that an AI/ML software device would.

The information provided focuses on the device description, intended use, and substantial equivalence to a predicate device based on design and function, not on performance against specific metrics or a clinical study evaluating its effectiveness in a quantitative manner as would be expected for software or diagnostic devices.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's how the information that is available could be presented:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided documents, as this is a 510(k) for a physical implant based on substantial equivalence, not a software performance study. The implicit "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The primary "performance" reported is its intended use to "provide strong and stable internal fixation with minimal soft tissue irritation." This is a qualitative statement of its function, not a quantitative performance metric.

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

• Sample Size for Test Set: Not applicable. No test set for performance evaluation is described. The 510(k) relies on comparison to a predicate device, not empirical testing data against a defined test set of cases.
• Data Provenance: Not applicable. No data or specific test cases are mentioned.

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

• Number of Experts: Not applicable. No ground truth establishment for a test set is described.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. No test set is described.

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:

• MRMC Study: No. This device is a physical intramedullary nail, not an AI-assisted diagnostic tool or software.
• Effect Size: Not applicable.

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

• Standalone Performance Test: No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: Not applicable. The FDA's substantial equivalence determination for this device is based on its design, materials, and intended use being similar to a legally marketed predicate device, not on specific ground truth data for a performance study.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does provide regarding "acceptance" for market entry:

• Mechanism of Acceptance: Substantial Equivalence to a Predicate Device (T2 Supracondylar Nail System is substantially equivalent to a previously marketed intramedullary nail system).
• Basis for Substantial Equivalence: Similarities in design (one-piece round profiled shaft, cannulated, closed-section, proximal rounded end), available dimensions (lengths, diameters), and components (intramedullary nails, locking screws, condyle screws, condyle screw nut, end cap), as well as the intended use (internal fixation) and indications for use (various femoral fractures, pseudoarthrosis, osteotomy, pathologic fractures, etc.).
• Regulatory Outcome: FDA found the device substantially equivalent, allowing it to be marketed.

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