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InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only.

Intramedullary Nail and Accessories

The provided text describes a 510(k) premarket notification for the "TriGen InterTAN" intramedullary nail. For medical devices undergoing 510(k) clearance, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device, rather than performance against pre-defined numerical thresholds or the kind of study typically associated with AI/software devices.

This document focuses on the mechanical and clinical data supporting substantial equivalence, not a standalone performance study as would be seen for an AI diagnostic.

Here's a breakdown of the requested information based on the provided text, recognizing the context of a 510(k) for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of this 510(k) submission for a physical orthopedic implant. The "test" here refers to mechanical testing, not a clinical trial with a patient sample.
• Data Provenance: The mechanical test data would be generated in a lab setting, likely in the US, by Smith & Nephew, Inc. This is not patient data, so "retrospective or prospective" does not apply.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not applicable. The "ground truth" for mechanical testing is based on engineering specifications and physical measurements, not expert consensus on diagnostic images.
• Qualifications of Experts: The data would have been reviewed by engineers and potentially clinicians to interpret mechanical test results in the context of clinical relevance, but the text doesn't specify these individuals or their qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance of human readers, often with and without AI assistance, which is not applicable to a physical orthopedic implant like the TriGen InterTAN nail.

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

• Standalone Performance: No, a standalone performance study was not done. This concept is applicable to AI algorithms, not a physical medical device. The "standalone" performance here refers to the mechanical integrity of the nail itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for demonstrating the equivalence of the TriGen InterTAN nail is primarily based on mechanical test data demonstrating its ability to withstand "expected in vivo loading without failure," compared to established performance of predicate devices. This is an engineering standard, not clinical pathology, expert consensus, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this device.

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