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The QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL).

The QuestLock ACL Fixator is made from Titanium alloy.

This document is a 510(k) summary for a medical device called the "QuestLock ACL Fixator." It provides information about the device's intended use and substantial equivalence, but it does not contain the detailed study information or acceptance criteria requested in your prompt.

Specifically, the document states:

• "The QuestLock ACL Fixator demonstrates acceptable pull out strengths."

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about a standalone algorithm performance study. (This is a physical device, not an algorithm).
7. The type of ground truth used. (It mentions "pull out strengths," which implies quantitative mechanical testing, but no specific ground truth definition is given).
8. Sample size for the training set. (Not applicable for this type of device testing).
9. How the ground truth for the training set was established. (Not applicable for this type of device testing).

To answer your prompt fully, you would need access to the full 510(k) submission or the detailed testing report referenced in this summary.

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