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Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.

The SHC is an internal fixation device consisting of multiple components; Standard Hip Nail, Fin Hip Nail (Intramedullary Nails), Bone Plates, Interlocking Screws, Compression Screws, Bone Screws, and a set of Surgical Instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138 or F139. All implants are single use and provided nonsterile.

This document is an FDA 510(k) Premarket Notification for the SIGN Hip Construct (SHC). It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets clinical acceptance criteria. Therefore, much of the requested information regarding clinical studies, sample sizes, expert involvement, and ground truth generation is not available in this document.

Here's a breakdown of the available and unavailable information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance that would be found in a clinical study. Instead, it relies on bench testing to demonstrate equivalent mechanical performance to a previously cleared predicate device.

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

• Sample size for test set: Not applicable and not mentioned. This document describes non-clinical bench testing, not a clinical trial with a "test set" of patient data.
• Data provenance: Not applicable. The "data" refers to results from mechanical bench testing, not patient data.

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

Not applicable. Ground truth for clinical cases is not established as this document describes non-clinical bench testing.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication.

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 a medical device (intramedullary fixation rod), not an AI diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

Not applicable. The "ground truth" here is the physical properties and mechanical performance of the device as measured in controlled laboratory settings (bench testing), compared against established standards and predicate device performance.

8. The sample size for the training set

Not applicable. This document does not describe the development of a machine learning model or an algorithm that requires a training set.

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

Not applicable. As above, there is no training set for an algorithm.

Summary of what the document does provide regarding device performance:

The document focuses on demonstrating substantial equivalence for the SIGN Hip Construct (SHC) to its predicate devices, primarily K083582 (SIGN Hip Construct (SHC)), K022632 (SIGN IM Nail), and K021932 (Synthes 6.5mm Cannulated Screw).

The study that proves the device meets the acceptance criteria (of substantial equivalence) is non-clinical performance data (bench testing).

• Type of Study: Cyclic fatigue testing simulating walking gait. These tests were explicitly stated to be duplicates of tests performed for the primary predicate device.
• Purpose: To validate that the device can withstand patient use until fracture consolidation occurs and to ensure safety and effectiveness given the expanded indications (reverse oblique fractures and osteotomies) and additional lengths compared to the predicate SHC.
• Results: "The results did not raise any issues on the safety or effectiveness of the device." The conclusion states that the testing data indicates the proposed device is "safe and effective, and performs as well or better than the predicates," supporting the substantial equivalence claim.
• Grounds for Acceptance: Substantial equivalence is established based on the similar design, performance, functions, intended use, and materials to the predicate devices, substantiated by the non-clinical bench testing results.

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