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The DePuy DuPont Absorbable Set Screw is intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament reconstruction.

The DePuy DuPont Absorbable Set Screw is a fully threaded, cannulated, headless cancellous bone screw with a blunt tip. It is manufactured from poly-L-lactic acid (PLLA) and is available in a 9.0mm diameter in seven lengths (20, 25, 30, 35, 40, 45, and 50mm). The screw is inserted by a square headed drive which is broached into the minor diameter of the screw body. The screw is used to compress the bone block against the wall of the bone tunnel and secure the ACL graft. The screw is gradually resorbed by the body.

This document (K972494) is a 510(k) premarket notification for a medical device and does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study design.

Specifically, this submission grants clearance based on the device's substantial equivalence to previously marketed devices, rather than requiring extensive clinical studies with specified acceptance criteria and performance metrics as would be found in a Premarket Approval (PMA) application or a more comprehensive de novo submission.

Therefore, many of the requested data points (such as acceptance criteria, reported performance values, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) are not typically included or required in a 510(k) submission based on substantial equivalence.

Here's what can be inferred or stated based on the provided document:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for this 510(k) submission. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: No specific quantitative performance data (e.g., strength, resorption rate) is reported for the DePuy DuPont Absorbable Set Screw in this document. The document primarily focuses on describing the device and comparing its characteristics to predicate devices.

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

• No "test set" in the context of a performance study with human or animal subjects is described. The substantial equivalence determination is based on a comparison of device design, materials, and intended use.

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 as there is no described test set requiring expert ground truth establishment for performance evaluation.

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

• Not applicable.

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-powered diagnostic tool. MRMC studies are not relevant to its clearance.

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):

• The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices. The DePuy DuPont Absorbable Set Screw demonstrates substantial equivalence by sharing the "same principles of graft fixation" and similar design/material characteristics with these predicate devices.

8. The sample size for the training set:

• Not applicable. There is no training set in the context of an algorithm.

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

• Not applicable.

Summary based on the document:

This 510(k) clearance is based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The primary arguments for equivalence are:

• Intended Use: All devices (DePuy DuPont Absorbable Set Screw and predicates) are intended for "early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament (ACL) reconstruction."
• Principles of Operation: They "employ the same principles of graft fixation."
• Technological Characteristics: Comparisons are made regarding design (fully threaded, cannulated, headless, blunt/pointed/tapered tip), dimensions (9.0mm diameter, various lengths), and materials (PLLA for the proposed device and Hyloc; titanium for others). Specific mention is made that the DePuy DuPont Absorbable Set Screw and the Hyloc Interference Screw are manufactured from PLLA with the "same specifications and obtained from the same supplier."

The FDA's review concludes that the device is substantially equivalent, and therefore, it is considered safe and effective for its stated indications for use under the general controls provisions of the Act. No specific performance study with quantifiable acceptance criteria or detailed clinical outcome data is presented in this 510(k) summary.

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