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The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal nonunions and malunions and revisions procedures.

The AOS Solid Locking and Telescoping Lag Screws are used in the AOS Trochanteric Nail System, in conjunction with the AOS Trochanteric Nail. Both AOS screws can be locked to the nail. The Telescoping Lag Screw allows the threads to collapse within the barrel.

This document describes a 510(k) premarket notification for the "AOS Trochanteric Nail System, Telescoping (TC") Lag Screw and Solid Locking Lag Screw." This is a medical device for internal fixation of femoral fractures, specifically for the trochanteric and subtrochanteric regions.

The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria through clinical or comprehensive standalone studies as might be done for an AI/CAD device.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies) are not applicable or cannot be extracted from this type of regulatory submission for a traditional orthopedic implant.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of traditional orthopedic implant, "acceptance criteria" are typically met by demonstrating that the device performs equivalently or better than predicate devices in specific mechanical tests, and shares the same intended use, fundamental technology, and materials. The "reported device performance" is the outcome of these mechanical tests, specifically demonstrating substantial equivalence.

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

• Sample Size for Test Set: Not applicable in the context of human data or AI model evaluation. The "test set" here refers to the physical devices subjected to mechanical testing. The exact number of devices tested for each mechanical test (static, fatigue, torque) is not specified, but the tests were performed "in accordance with ASTM F384" and "ASTM F543" which would specify sample size requirements.
• Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing of the physical device components.

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

• Number of Experts & Qualifications: Not applicable. Ground truth, in this context, is established by adherence to recognized industry standards (ASTM F384, F543) and validated mechanical testing methodologies.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Results are based on physical measurements from standardized mechanical tests.

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 is a physical orthopedic implant, not an AI/CAD diagnostic device.

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

• Standalone Study: Not applicable. This is a physical orthopedic implant, not an algorithm. The "standalone performance" refers to the mechanical performance of the device components themselves in controlled in vitro tests.

7. The Type of Ground Truth Used

• Type of Ground Truth: Established through standardized mechanical testing protocols (ASTM F384, ASTM F543). The "ground truth" for this device is the objective physical performance and material properties as measured under these standards, compared to predicate devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm. The "training" for this type of device occurs during its design and manufacturing process, using engineering principles and established material science.

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

• Ground Truth for Training Set: Not applicable as a distinct "training set" with established ground truth, in the context of AI/ML, does not apply here. The "ground truth" influencing the design and development (analogous to 'training') would be engineering specifications, material properties, biomechanical principles, and the performance characteristics of successful predicate devices.

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