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The specimen retrieval bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.

The ReliaCatch™ 10mm Specimen Retrieval Bag and ReliaCatch™ 12mm Specimen Retrieval Bag consist of a long cylindrical tube and a rip-stop nylon bag that encapsulates and contains specimens for removal from the body cavity. The device contains a handle used to retract and deploy the bag. The specimen bag is designed for introduction and use through all appropriately sized trocar sleeves.

The provided text describes a 510(k) premarket notification for the ReliaCatch Specimen Retrieval Bag, comparing it to a predicate device. However, it does not contain the detailed acceptance criteria for the device's performance, nor does it present a study proving the device meets specific acceptance criteria in a structured manner.

The document primarily focuses on establishing substantial equivalence to a predicate device based on device description, intended use, and a general summary of performance data. It lists types of performance tests conducted but does not provide the quantitative acceptance criteria or the specific results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or training set information. This information is not present in the provided document.

The document states:

• "Summary of testing includes description of test methods, sample size, acceptance criteria, and pass/fail results. Objective acceptance criteria were defined for each test."
• "Performance testing included: Leak Rate Evaluation, Trocar Insertion Force, Trocar Removal Force, Pouch Deployment Force, Pouch Retraction Force, Pouch Cinch Force, Pouch Burst Pressure, Human Factors/Usability"

This indicates that such information exists but is not detailed within this FDA letter or the included 510(k) summary.

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