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The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.

The Bilok®ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.

The Bilok® ST Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).

This submission pertains to a 510(k) premarket notification for a medical device called the Bilok® ST Screw. In 510(k) submissions, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through clinical trials with specific acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria (especially regarding performance metrics like sensitivity, specificity, etc.) is generally not applicable for a 510(k) submission like this one.

Here's a breakdown of why and what information is available in the provided text:

• No specific acceptance criteria or a study proving those criteria are met for performance as a diagnostic device. The 510(k) process relies on demonstrating the new device is as safe and effective as a predicate device already on the market.
• The provided text explicitly states "Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness." This is the core of a 510(k) review.

Let's address each of your points based on the provided document and the nature of a 510(k) for this type of device:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria for a 510(k) Submission: The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that "Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device..." This is the "performance" demonstrated for a 510(k) in terms of regulatory approval. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) provided as this is not a diagnostic device and doesn't require such clinical performance data for 510(k) clearance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for this 510(k). This device is a bone screw used in surgery. The substantial equivalence argument relies on comparing its design, materials, and mechanical properties to a predicate device, along with non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing). Clinical "test sets" of patients are generally not required for this type of 510(k) submission to demonstrate substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There is no "test set" in the context of clinical images or diagnostic outcomes that requires expert consensus for ground truth for this medical device submission.

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

• Not applicable. No clinical test set requiring adjudication in this context.

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 (bone screw), not an AI-assisted diagnostic tool.

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

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

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

• Ground Truth for a 510(k) of a Physical Device: For a device like a bone screw, the "ground truth" for demonstrating safety and effectiveness for a 510(k) involves adherence to established standards for materials, biocompatibility, sterilization, and mechanical performance (e.g., tensile strength, fatigue life), as well as comparison to a predicate device with a known history of safe and effective use. This is primarily established through non-clinical laboratory testing and engineering analysis, not clinical outcome data or expert consensus on diagnostic images.

8. The sample size for the training set

• Not applicable. There is no "training set" in the sense of machine learning for this device.

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

• Not applicable. No training set exists for this device in this context.

In summary, this 510(k) submission for the Bilok® ST Screw relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than extensive clinical studies or the establishment of ground truth through expert review of clinical data.

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