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Hem-o-lok® Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.

The provided text is a 510(k) summary for the Hem-o-lok® Ligating Clips. This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and performance testing. It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the kind of clinical performance study to prove the device meets acceptance criteria as typically understood for AI-based medical devices.

The product codes FZP, and regulation 21 CFR 878.4300, specifically describe an "Implantable Clip," which is a physical surgical device, not a software or AI-based diagnostic tool.

Therefore, the requested information regarding acceptance criteria, study details (sample size for test/training sets, experts, adjudication, MRMC studies, standalone performance, ground truth, etc.) for an AI/ML device's performance cannot be extracted from this document, as it pertains to a different type of medical device entirely.

The "Performance Data" section (J.) describes non-clinical benchtop verification testing for physical characteristics like clip latching, resistance to leakage, and clip removal, as well as biocompatibility testing according to ISO 10993 standards. This is for a physical implantable device, not an AI or diagnostic software.

In summary, this document is not relevant to the posed question about a study proving an AI/ML device meets acceptance criteria.

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