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The China 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. China Nails are for single use only.

Subject devices of this submission are China Nails and Accessories. The implant components included in the system are described in the following table.

The implants are manufactured from titanium alloy (Ti-6Al-4V).

This document describes the Smith & Nephew China Nails and Accessories, an intramedullary nail system. The information provided is for a 510(k) premarket notification, which is a submission to the FDA demonstrating that the device is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" and "study" are framed within the context of demonstrating substantial equivalence through non-clinical performance testing rather than a clinical trial with specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (for mechanical testing): The document does not specify the exact sample size for the fatigue testing and wear evaluation. It only states that "Mechanical testing was conducted." Given the nature of medical device premarket notifications, these tests typically involve a statistically relevant number of samples to demonstrate performance.
• Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, Smith & Nephew, Inc. There is no mention of human subject data, and the context indicates that clinical data was not needed for this submission. The testing would have been performed in a laboratory setting.

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

• Ground Truth for Test Set: Not applicable in the traditional sense for a clinical study. For bench testing, the "ground truth" is established by engineering principles, accepted test methods (e.g., ASTM or ISO standards for medical implants), and comparison against predicate device performance. The experts involved would be biomechanical engineers, material scientists, and regulatory specialists within Smith & Nephew responsible for designing, executing, and interpreting the mechanical tests. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving multiple human readers or evaluators to resolve discrepancies in diagnoses or assessments. This submission relies on non-clinical mechanical testing and comparison to predicate devices, where adjudication of subjective interpretations is not relevant.

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

• Not applicable. This is not an AI/software device and no MRMC study was conducted. The device is a physical orthopedic implant.

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

• Not applicable. This is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:
  • Engineering Standards and Specifications: Adherence to established material properties and dimensional specifications.
  • Bench Test Results: Quantitative and qualitative data from fatigue testing and wear evaluation according to industry-accepted protocols.
  • Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed predicate devices (Smith & Nephew TRIGEN InterTAN, Smith & Nephew SURESHOT TAN and Accessories, Smith & Nephew TRIGEN Low Profile Bone Screws). The China Nails and Accessories are considered "substantially equivalent" if their performance in these tests is comparable to the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set. The "training" for such a device involves product development, manufacturing processes, quality control, and adherence to design specifications based on engineering principles.

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

• Not applicable for the same reasons as point 8.

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