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The Matryx™ Interference Screw is intended for use in interference fixation of bone-patellar tendon -- bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.

The Matryx™ Interference Screw is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active sepsis or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.

The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-" calsium phosphate. The predicate device Osteo ACL Screw is made of the very same raw material. Lengths of implant are 20 30 mm - Diameters of implant are 7mm-9mm. - The only modifications that were made are: - Change of trade name. This change is updated in labelling. - Minor modifications and further definition of tolerances of screw design.

The provided text (K052080) describes a 510(k) premarket notification for the Matryx™ Interference Screw. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a submission to the FDA for substantial equivalence, focusing on comparisons to a predicate device (Linvatec Biomaterials Ltd Osteo ACL Screw, K032894) and minor modifications to an existing design. It discusses the device's composition, dimensions, intended use, and substantial equivalence to a cleared predicate device.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm-only) performance study.
7. The type of ground truth used (pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in performance studies, validation reports, or clinical trial summaries, which are not present in this 510(k) summary document. The 510(k) process for this device focused on demonstrating substantial equivalence based on material composition and design similarity to a previously cleared device, rather than new performance studies with specific acceptance criteria that would require the detailed information you are requesting.

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