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Mitek meniscal fasteners "H" Fix PDS are intended for use in the repair or torn meniscal tissue in the red/red zone of the meniscus (outer 1/3 ) as well as the repair of a separation of a synovium.

Mitek Meniscal Fasteners are molded polymeric implants used to repair tears in the meniscus. Fasteners provide the means for firmly securing together the edges of a tear in the meniscus or across the synovial meniscal junction. The fasteners are available in absorbable PDS (polydioxanone). The "H" Fix is cylindrical in cross section and configured to have one leg of the letter "H" in a 90 degree opposed position to the other.

The provided text describes a medical device, the Mitek Absorbable "H" Device, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria.

The document is a 510(k) submission, a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. This process primarily relies on demonstrating substantial equivalence, rather than establishing performance against specific, quantitatively defined acceptance criteria through a clinical study.

Therefore, I cannot fulfill your request for the detailed table and study breakdown as the necessary information is not present in the provided text.

Specifically, the document focuses on:

• Device Description and Function: What the device is and how it works.
• Materials Used: PDS (polydioxanone).
• Intended Use: Repair of torn meniscal tissue in the red/red zone (outer 1/3) of the meniscus.
• Comparison to Predicate Device(s): How it's similar to the Acufex T-Fix device and PDS II Suture.
• Non-Clinical Tests: Only mentions "pull tests from cadaver meniscus provided an average failure load of 12.06 pounds." This is a single data point from a non-clinical test, not a comprehensive study against acceptance criteria.
• Absorption Characteristics of PDS: Information on the degradation and strength retention of the PDS polymer over time, derived from animal implantation studies.

There is no mention of:

• A table of acceptance criteria with corresponding performance.
• Test set sample sizes, data provenance, or ground truth establishment.
• Number or qualifications of experts.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or standalone performance.
• Training set details.

The FDA letter (K970119) indicates that the device was found "substantially equivalent" to a predicate device, which allows it to be marketed. This regulatory pathway does not typically require the rigorous clinical trial evidence-gathering that would involve defining and meeting specific acceptance criteria in the manner you've outlined.

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