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Lapro-Clip™ absorbable ligating clip cartridges are intended for use as absorbable ligatures. Lapro-Clip™ absorbable ligating clip cartridges are radio transparent and will not interfere with interpretations of postoperative X-ray, CT, or MRI scans. The Lapro-Clip™ absorbable ligating clip cartridge may be used for ligation of the cystic duct and other general ligation.

The Lapro-Clip™ absorbable ligating clip is delivered by a single use cartridge and actuated by a reusable applier. Lapro-Clip™ absorbable ligating clip cartridges are molded from two polymers: polyglycolic acid and polyglyconate. The outer body is polyglycolic acid and slides over a polyglyconate inner track. Lapro-Clip™ absorbable ligating clips are supplied sterile and undyed. Lapro-Clip™ absorbable ligating clip cartridges are available in two sizes, Medium/Large and Large. Clips are supplied one clip per single use cartridge with either one, two, or six cartridges per sterile package. The Lapro-Clip™ reusable clip appliers are available in three sizes: The Lapro-Clip™ short reusable clip applier is 11cm in length with a shaft diameter of 10mm. The Lapro-Clip™ standard reusable clip applier is 26.5cm in length with a shaft diameter of 10mm. The Lapro-Clip™ long reusable clip applier is 33cm in length with a shaft diameter of 10mm.

I am sorry, but the provided text does not contain the information required to populate the requested table and answer the questions about acceptance criteria and a study proving device performance as it pertains to a machine learning or AI device.

The document is a 510(k) premarket notification from the FDA for a medical device called the "Lapro-Clip™ Auto Suture™ Reusable Long Clip Applier." This device is a surgical instrument used to deploy absorbable ligating clips.

The document discusses the substantial equivalence of this device to a predicate device based on technological characteristics like materials, performance characteristics (biocompatibility, stability, lifecycle reliability), sterilization, and cleaning studies. It also lists several in-vitro tests conducted to support its intended use.

However, none of this information relates to the performance of an AI or machine learning device. The acceptance criteria and study details requested in your prompt (e.g., sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are specific to the validation of AI/ML models, which is not the subject of this 510(k) submission.

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