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To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

The TriABSorb™ composite screw is bio-absorbable sterile single use tapered and has a smooth threaded bone screw, which provides interference fixation of soft tissue nas a smooth througou bone patellar grafts during Anterior Cruciate Ligament repair through arthroscopy or arthrotomy. The device is cannulated, tapered with a smooth threaded design, which provides The device to ourmalatour tapers and bone-tendon-bone patellar grafts during Interience inxation of Sont trough arthrough arthroscopy or arthroscopy or arthrotomy procedures. The implants are made of similar biopolymer: PLLA (poly L-lactide acid), Tri-Calcium phosphate (TCP), Hydroxyapatite (HA). The screw comes in multiple lengths (20mm to 45mm), multiple diameters (6mm to 12mm) in each length and left and right thread design, resulting in a set of screws adapted to the morphology of the graft and the patient.

The provided text is a 510(k) summary for a medical device (TriABSorb™ Composite Screw) and the FDA's clearance letter. This type of document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive standalone testing.

Therefore, much of the requested information (acceptance criteria, specific study results, sample sizes, expert involvement, adjudication, MRMC studies, effect sizes) is not present in the provided text.

Here is what can be inferred or stated based on the given document:

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

• Acceptance Criteria: Not explicitly stated as quantifiable acceptance criteria with thresholds in this document. The primary "acceptance criteria" here are demonstrating substantial equivalence in material, design, and intended use to predicate devices.
• Reported Device Performance: No specific performance metrics (e.g., tensile strength, degradation rate, clinical success rates) are reported in a quantifiable manner as part of a formal study in this document. The document asserts that minor design modifications "do not affect the use, safety and effectiveness of the device" and that the composite screw has "similar characteristics" to the polymers used in predicate devices.

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable/not provided. No specific test set of patients or specimens is described as part of a performance study in this document. The substantial equivalence relies on comparisons to existing predicate designs and materials.
• Data Provenance: Not applicable.

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

• Not applicable/not provided. No "ground truth" establishment by external experts for a test set is described. The FDA itself acts as the expert body reviewing the substantial equivalence claim.

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

• Not applicable/not provided. No adjudication method for a test set 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:

• Not applicable. This device is a surgical 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 device is a surgical screw.

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

• Not applicable/not provided in the context of a performance study. The "ground truth" for FDA clearance in this context is the established safety and effectiveness of the predicate devices, to which the new device is compared for substantial equivalence.

8. The sample size for the training set:

• Not applicable/not provided. There is no mention of a "training set" as this is not a machine learning or AI-based device.

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

• Not applicable/not provided.

In summary: The provided document is a 510(k) premarket notification, which establishes substantial equivalence rather than presenting clinical study results against predefined acceptance criteria for novel device performance. The "study" referenced is the compilation of information and comparisons demonstrating that the TriABSorb™ Composite Screw is as safe and effective as its predicate devices, based on material properties, design, and intended use.

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