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The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, steel sheet, plug, inner sleeve, outer sleeve, pull ring, outer introducer handle, joint, tightening line, pick rod and inner introducer handle. The device is available in a series of models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-420. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use

This document is a 510(k) premarket notification for a "Disposable Specimen Retrieval Bag" and does not describe an AI/ML medical device. Therefore, it does not contain information about acceptance criteria for an AI device, a study proving an AI device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document is for a physical medical device and is primarily focused on demonstrating "Substantial Equivalence" to a previously marketed predicate device based on non-clinical performance and biocompatibility tests.

The device is a physical medical device, not an AI medical device. Therefore, the requested information regarding AI device acceptance criteria, studies, and related data is not applicable and not present in the provided text.

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