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The Inion Trinion™ Biodegradable Meniscus Screw is indicated for use in the fixation of longitudinal vertical meniscus lesions (bucket handle) located in the vascularized area of the meniscus (red-red and red-white areas).

The Inion Trinion™ Biodegradable Meniscus Screw is intended for use in the fixation of longitudinal vertical meniscus lesions (bucket handle) located in the vascularized area of the meniscus (red-red and red-white areas). Screws are offered in different lengths typical for this application. The system will be provided sterile to the user and is not to be re-sterilized. The Inion Trinion™ Biodegradable Meniscus Screw is designed to be used with customized instrumentation. The Inion Trinion™ Biodegradable Screw is made of resorbable polylactic acid / trimethylenecarbonate copoylmers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion Trinion™ Biodegradable Meniscus Screws are offered both undyed and coloured for better visualization during surgical operation. The Trinion™ Biodegradable Meniscus Screw gradually looses its strength during 18-36 weeks. Bioresorption takes place within two to three years.

I apologize, but this document does not contain the specific information required to complete your request. The provided text is a 510(k) summary for a medical device (Inion Trinion™ Biodegradable Meniscus Screw) and primarily focuses on its equivalence to previously marketed products rather than detailed performance studies and acceptance criteria as you've requested.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes for test sets, data provenance, or expert qualifications for ground truth.
• Details on adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used beyond a general statement of "clinical success" for predicate devices.
• Sample size for training sets or how ground truth for training sets was established.

This document describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on material properties and biomechanical testing. It is a regulatory submission, not a detailed scientific study report with the kind of performance metrics you've asked for.

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