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The LactoSorb® Meniscal Screw is indicated for the repair of vertical longitudinal fullthickness tears (i.e. bucket-handle) in red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The LactoSorb® Meniscal Screw is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue.

This document does not contain information about a study proving that the LactoSorb® Meniscal Screw meets specific acceptance criteria in terms of performance.

The provided text is a 510(k) summary for the LactoSorb® Meniscal Screw, which primarily focuses on demonstrating substantial equivalence to a predicate device (LactoSorb® Meniscal Staple, K982095) for regulatory clearance. It describes the device's intended use, materials, and provides the FDA's clearance letter.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a performance study.

The only relevant information that can be extracted is:

• Device Name: LactoSorb® Meniscal Screw
• Intended Use: Repair of vertical longitudinal full-thickness tears (i.e., bucket-handle) in red-red and red-white zones of the meniscus. Not to be used for meniscal tears in the avascular zone.
• Predicate Device: LactoSorb® Meniscal Staple (K982095)
• Material: Bioresorbable and biocompatible polymers (LactoSorb® resorbable copolymer, synthetic polyester derived from lactic and glycolic acids).
• Material Evidence: "The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue." (This is a general statement about the material, not a specific performance study of the screw device itself.)

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