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The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.

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

The Weck Auto Endo5 Hem-o-lok Ligating Clip Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used by a surgeon or physician's assistant during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5 applier is actuated by a trigger, which is housed in a body assembly. Adjacent to the body is a turn knob that is used to rotate the applier jaws. The Auto Endo5 applier is 44 cm long with a working length of 29.7 cm. This applier can be used with a 5 or 5.5 mm cannula.

The provided document is a 510(k) summary for the Weck Auto Endo5 Hem-o-lok Ligating Clip Applier. It details the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

The document states:

• "Non-clinical performance testing has been conducted following product sterilization, aging, and simulated distribution in order to support a change to the dry lubricant applied to various applier components." (Page 6)
• "Based upon the comparative test results, the proposed Weck Auto Endo5 Hem-o-lok Ligating Clip Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K021808. The modification made to the Auto Endo5 Ligating Clip Applier does not introduce any new issues of safety and effectiveness." (Page 6)

This indicates that performance testing was done, and comparative test results were used to establish substantial equivalence. However, the document does not provide the acceptance criteria for this testing, nor does it detail the study design, sample sizes, ground truth establishment, or expert-related information that you've requested.

Therefore, I cannot fulfill your request with the input provided. The requested information (acceptance criteria, specific study details כמו sample size, provenance, expert details, adjudication, MRMC, standalone, ground truth type and training set details) is not present in this 510(k) summary.

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