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The Specimen Bag is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Specimen Bag is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Specimen Bag is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.

The provided text is a 510(k) Pre-Market Notification for a medical device (Specimen Bag models), indicating it is seeking substantial equivalence to a predicate device. This document primarily details the device's intended use, description, and comparison to the predicate device, along with the non-clinical tests performed.

However, the provided text does not contain information about a study that proves a device meets acceptance criteria related to an AI/Machine Learning algorithm's performance, nor does it provide the detailed breakdown requested regarding acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies (MRMC).

The "tests listed below demonstrate the performance of Specimen Bag meets the requirements of its pre-defined acceptance criteria and intended uses" (page 5) refer to a series of engineering and biocompatibility tests typical for a physical medical device, not an AI/ML algorithm. These tests include:

• Tensile strength
• Bag load-bearing
• Opening force
• Rope tension test
• Puncture Force Test
• Pouch Leakage Test
• Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-Mediated Pyrogenicity)

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets AI-related acceptance criteria, as this information is not present in the provided document. The device is a "Specimen Bag," a physical medical device, not an AI/ML-driven diagnostic or assistive tool.

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