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Bioabsorbable Interference screw is used for fixation of bone-tendonbone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

Indications:

1. The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or softtissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
2. The screw is indicated for single use only.

The Bioabsorbable Interference Screw is a screw that has a range of diameters from 7 to 9 mm and a length that ranges from 20 mm to 30 mm. The material of construction for both screws is polylactic acid.

The provided text describes a 510(k) premarket notification for a medical device (Bioabsorbable Interference Screw) and its substantial equivalence to a predicate device. However, it does not contain the detailed information needed to fill out all the requested categories regarding acceptance criteria and a study proving device performance in the way a modern AI/ML device submission would.

This document predates modern AI/ML device regulations and focuses on demonstrating substantial equivalence through comparable design, materials, and intended use, rather than a performance study with specific quantitative acceptance criteria as would be expected for AI/ML.

Here's an attempt to extract what is available and note what is missing based on the provided text:

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

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

• Sample Size: Not specified in the provided text. The text only states "Both screws had results which are recorded in the test results located in attachment one."
• Data Provenance: Not specified.

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 to this type of device submission. This information is typically relevant for interpretative devices, especially those using AI/ML, where expert consensus often establishes ground truth. This document pertains to a mechanical fixation device.

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

• Not applicable to this type of device submission.

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

• No, a MRMC comparative effectiveness study was not done. This is not an AI/ML device.

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

• No, a standalone performance study was not done in the context of an AI/ML algorithm. This is a mechanical device.

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

• The "ground truth" for this type of device would be based on engineering performance metrics (e.g., pull-out strength, degradation rates, biocompatibility) tested against established biomechanical standards and compared to the predicate device. The specific metrics are not detailed in the provided summary but are implied to be in "attachment one".

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable.

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