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indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, II, III, and IV trochanteric and subtrocianteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity; supracondylar fractures and distal femoral fractures using a 95° barrel angle

The EZ-Fix™ Compression Hip/Supracondylar Screw system is manufactured from titanium (6Al-4V ELI) per ASTM F136. It is light weight. The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), is available in 95°, 130°, 135°, 140°, 145° and 150° angles and is manufactured and tested per ASTM specifications F787 and F384 respectively. The bone screw hole pattern is offset and the most proximal hole accepts a large diameter cannulated screw. The plates shall be available in 3 hole, 4 hole, 5 hole, 6 hole, 10 hole, 12 hole and 14 hole lengths. The bone screws are self-tapping and the lag screws are available in 50-150 mm (5 mm increments) lengths. A compression screw threads into the lag screw to allow for optimal compression of the lag screw into the barrel during implantation.

This document describes a 510(k) premarket notification for the EZ-Fix™ Compression Hip/Supracondylar Screw (CHS) System. The focus of this submission is on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, a direct response to your request, which expects detailed performance metrics, sample sizes, and expert adjudication for a medical image analysis device, is not fully applicable.

However, I can extract the relevant information from the provided text that aligns with your request's spirit, particularly regarding the device's testing and the "acceptance criteria" through the lens of equivalence.

Here's an interpretation based on the document:

The "acceptance criteria" for this device are its ability to meet ASTM test standards for metallic nail-plate appliances (F384) and, crucially, to demonstrate equivalence in these test values to legally marketed predicate devices. The "study" proving this is the biomechanical testing performed, and the "reported device performance" is its successful comparison to predicate devices based on these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a mechanical implant, the "performance" is primarily defined by material properties, design features, and structural integrity under simulated conditions, benchmarked against predicate devices and established ASTM standards. The acceptance criteria are implicit in achieving comparable results to predicates under these standards.

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

• Sample Size: Not explicitly stated for the biomechanical testing of the EZ-Fix™ device itself. However, for sterilization validation of sterile devices, 10% of each production lot is tested, broken down into 6% for bacteriostasis/fungistasis studies and 4% for bioburden recovery determination.
• Data Provenance: The biomechanical testing was performed by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida. It is a retrospective comparison in the sense that the test results of a new device are compared against known performance characteristics (or published data, or internal data) of already marketed predicate devices.

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

This type of information is not applicable to the biomechanical testing of a compression hip/supracondylar screw system. "Ground truth" in this context is established by objective engineering and material science standards (ASTM F384) and the measured mechanical properties of the device, compared against predicate devices. There wouldn't be "experts" in the sense of clinicians establishing a "diagnosis" or "interpretation." The expertise lies in the biomechanical engineers at the testing lab.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments or when reconciling differing expert opinions, common in medical imaging or clinical trials. For biomechanical testing, the results are objective measurements against a standard.

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 device is a surgical implant, not an AI or diagnostic imaging tool. It does not involve "human readers" or "AI assistance" in its direct function.

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

Not applicable. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For the biomechanical testing, the "ground truth" equates to:

• Objective Engineering Standards: Adherence to ASTM F384 for metallic nail-plate appliances.
• Predicate Device Performance: The established and accepted mechanical performance characteristics of legally marketed, substantially equivalent devices. The EZ-Fix™ device's test values were compared for comparability.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, there is no "training set" for this type of device.

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