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The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The JuggerStitch Meniscal Repair Device is a permanent fixation anchor system comprised of UHMWPE suture, with two non-resorbable polyester sleeves. The device comes as a unit, pre-assembled on either a Straight or Curved inserter. The purpose of this submission is to introduce modifications to the Juggerstitch suture implant and inserter for ease of use.

This document is a 510(k) Premarket Notification for the JuggerStitch Meniscal Repair Device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven device. As such, the information required to answer the prompt directly, especially regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific ground truths for an algorithm, is not present in this document.

The document discusses non-clinical tests performed to verify the physical characteristics and performance of the mechanical device due to modifications made to a previously cleared device. These include:

• Static tensile testing: To verify the strength of the implant.
• Cantilever bend testing: To verify the bending strength of the inserter needles.
• Tissue penetration force testing: To verify the penetration force of the inserter needles.
• Advancement testing: To verify the force required to advance the depth adjuster and push button.
• Surgeon validation: To assess if the device meets its intended User Needs (related to ease of use of modifications).
• Sterilization validations: To show compliance with ISO standards.
• Packaging validations: To show compliance with ISO standards.

The document explicitly states: "Clinical data was not required to establish substantial equivalence between the subject JuggerStitch Meniscal Device and the predicate devices." This confirms that there was no clinical study, let alone one involving AI or algorithms, to assess the device's performance in a diagnostic or predictive capacity.

Therefore, I cannot provide the requested table and study details as they pertain to algorithm performance and acceptance criteria. The provided text describes a submission for a mechanical meniscal repair device, not a software or AI-driven medical device.

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