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The Variable Pitch Compression Screw System is indicated for alignment and stabilization of small bone fractures. Specifically:

· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand fractures, non-unions, or mal-unions

• Ligament reconstruction
• · Osteochondritis dissecans
• · Arthrodesis of the foot, ankle, wrist, elbow and hand

· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies,

and carpal/metacarpal osteotomies.

These procedures may be indicated as part of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

The Biomet Variable Pitch Compression Screw System offers headless, cannulated compression screws in three different diameters in various lengths. The screws are manufactured from Titanium Alloy (ASTM F136) and are either color anodized or passivated for ease of size identification. The system will also include instrumentation to aid the user in alignment and stabilization of fractures to the skeletal system.

The provided document is a 510(k) premarket notification for the Biomet Variable Pitch Compression Screw System. This specific document describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.

Crucially, this document does not outline acceptance criteria for the device's performance in a diagnostic or analytical context, nor does it describe a study to prove the device meets such criteria in terms of accuracy, sensitivity, or specificity. This is because the device is a bone fixation fastener, not a diagnostic tool or an AI/ML-driven medical device. The "performance" being assessed here is primarily mechanical and material, establishing its safety and effectiveness for its intended surgical purpose.

Therefore, many of the requested points are not applicable to this type of device and submission. I will address the relevant points based on the information provided in the document.

Acceptance Criteria and Study Details (Based on Provided Document)

Since this is a 510(k) for a physical medical implant (a screw system), the "acceptance criteria" and "study" are focused on demonstrating mechanical and material equivalence to a legally marketed predicate device, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML devices (e.g., specific thresholds for accuracy, sensitivity). Instead, the acceptance is based on demonstrating that the subject device's mechanical properties are comparable to or better than those of the predicate device, showing it is "substantially equivalent" and "will perform within the intended uses."

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

• Sample Size for Test Set: Not specified in terms of number of screws or test runs for the mechanical testing. "Non-clinical performance testing included mechanical testing to ASTM F543." This standard specifies how to perform the tests, but the specific number of units tested is not detailed in this summary.
• Data Provenance: The mechanical testing was likely conducted in a laboratory setting by the manufacturer or a contracted testing facility. No country of origin for specific test data is provided, but the manufacturer is Biomet Inc. based in Warsaw, Indiana, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

• Not applicable. For a mechanical device, ground truth is established by objective physical measurements and adherence to engineering standards (e.g., ASTM F543), not by expert consensus on, for example, image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically for subjective assessments, like medical image interpretation. Mechanical testing results are objective measurements.

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/ML diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant.

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

• Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the AI/ML sense. The "ground truth" for mechanical testing is defined by established engineering principles and the specified test methods within ASTM F543, aiming to objectively demonstrate material strength, fatigue resistance, and overall structural integrity under simulated physiological conditions.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of mechanical device.

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

• Not applicable. As there is no training set, there is no ground truth for it.

Summary of 510(k) Conclusion:

The FDA's review and the manufacturer's submission for the Biomet Variable Pitch Compression Screw System focused on demonstrating substantial equivalence to an already legally marketed predicate device (EBI, LLC BioDrive Micro - K092670). This was achieved by showing that the new device has:

• The same intended use and indications for use.
• Similar technological characteristics (materials, design features, sterilization methods).
• Non-clinical performance data (mechanical testing to ASTM F543) indicating that any differences in design or materials do not raise new questions of safety or effectiveness and that the device performs equivalently for its intended purpose.

No clinical studies were required or provided for this 510(k) given the established predicate and the nature of the device.

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