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

The PLLA cannulated interference screw is bio-absorbable sterile single use tapered and has a smooth threaded bone screw, which provides interference fixation of soft tissue grafts and bone-tendonbone patellar grafts during Anterior Cruciate Ligament repair through arthroscopy or arthrotomy. The device is cannulated, tapered with a smooth threaded design, which provides interference fixation of soft-tissue grafts and bonetendon-bone patellar grafts during anterior cruciate ligament repair and reconstruction through arthroscopy or arthrotomy procedures. 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 (PLLA cannulated interference screw). It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would.

The substantial equivalence determination is based on similarities in:

• Material: Both the PLLA screw and the predicate device use similar biopolymer (polylactic acid).
• Design: Overall similar design, with minor modifications not affecting reconstruction.
• Intended Use: Overall same intended use.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this document, as such a study is not presented.

Here's a breakdown of what can be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific pull-out strength, degradation rate targets in a clinical context). The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a legally marketed predicate device.
• Reported Device Performance: The document states that the polymer has undergone "many in vitro and in vivo testing," but no specific results or performance values are reported for the PLLA cannulated interference screw itself in human subjects or in a comparative study against specific criteria. The performance is inferred to be similar to the predicate device due to material and design similarities.

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. No performance study with a distinct test set is detailed in this 510(k) summary. The submission relies on demonstrating equivalence rather than presenting new performance data from a specific test set.

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. No performance study with a ground truth established by experts is detailed.

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

• Not applicable. No performance study requiring adjudication is detailed.

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 bioabsorbable interference screw, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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 or software.

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

• Not applicable. No specific ground truth for a novel performance study is used or described. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an algorithm or machine learning model for this physical device.

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

• Not applicable. See point 8.

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