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The ACL Avulsion Lag Screw is intended for fixation of bone to bone. This product is intended for use in repairing Type IIIB ACL avulsions.

A key to treating ACL avulsions is to determine whether the bony fragment is large enough to support internal fixation. The Arthrex Avulsion Lag Screw is specifically designed to allow rigid internal fixation of smaller bony fragments than has been possible with traditional screw designs. Because the avulsion screw is a cancellous bone screw, the risk of damage to the posterior neurovascular structures is minimized. If the fragment is too small, the transtibial suture technique should be used.

The provided text focuses on regulatory approval (510(k) submission) for a medical device, the Arthrex ACL Avulsion Lag Screw. It does not contain information about acceptance criteria, device performance studies, sample sizes (training or test sets), ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

This document is a 510(k) summary, which is typically a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This process primarily relies on comparing technological characteristics and intended use, and often does not require new clinical studies for acceptance criteria demonstration.

Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text.

Here's what I can extract and state:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., success rates, mechanical strength thresholds) or report performance metrics from a study against such criteria. The "performance" mentioned is primarily in the context of its intended function by design ("allow rigid internal fixation of smaller bony fragments") rather than quantitative study results.

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

• Cannot be provided. No study data, test sets, or sample sizes are mentioned.

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)

• Cannot be provided. No clinical study involving expert ground truth establishment is described.

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

• Cannot be provided. No test set or adjudication method is described.

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

• Cannot be provided. This device is a bone screw, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• Cannot be provided. This device is a physical medical implant, not an algorithm.

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

• Cannot be provided. No study data requiring ground truth is described.

8. The sample size for the training set

• Cannot be provided. No study data or training set is mentioned.

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

• Cannot be provided. No study data or ground truth establishment is mentioned.

Summary of available information regarding compliance criteria (not "acceptance criteria" in the performance study sense):

The document primarily focuses on demonstrating substantial equivalence to predicate devices. The "criteria" for this type of submission involve:

• Intended Use: The device must have the same intended use as a predicate, or a different intended use that does not raise new safety/effectiveness questions.
  • Reported Application: Fixation of bone to bone, specifically repairing Type IIIB ACL avulsions.
• Technological Characteristics: The device must have the same technological characteristics as a predicate, or different characteristics that do not raise new safety/effectiveness questions and are demonstrated to be as safe and effective.
  • Material: Titanium alloy 6AL-4V ELI, meeting ASTM F136 standards. This is explicitly stated to meet chemical and mechanical requirements in voluntary standards, implying this as a key "criterion" for material safety and performance.
  • Design: "Specifically designed to allow rigid internal fixation of smaller bony fragments than has been possible with traditional screw designs." This describes a design feature relevant to its intended use but is not quantified with performance data in this document.

Predicate Devices Used for Comparison:

The "study" in this context is the substantial equivalence comparison itself, as presented in the table comparing the Arthrex device to the Acumed and Aesculap bone screws. The "proof" is the argument that the materials (all titanium alloy per ASTM F136 or equivalent specification) and the general category of "fixation of bone to bone" intended use are similar enough that the device does not raise different questions regarding safety and effectiveness. The FDA's letter (K981187) confirms this substantial equivalence determination, allowing the device to be marketed.

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