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The Blue Eye (TS-905) is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions with a snare or endoscopic device.

The Blue Eye (TS-905), submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointenstinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.

This is not an AI/ML SaMD product. The provided text is a 510(k) summary for a medical device called "Blue Eye (TS-905)," which is a submucosal injection agent used in gastrointestinal endoscopic procedures. The information pertains to traditional medical device clearance, not an AI/ML-driven software device.

Therefore, the specific information requested about acceptance criteria, study details for AI/ML performance, sample sizes for test and training sets, expert qualifications, and adjudication methods for AI/ML ground truth cannot be extracted from this document because it is not applicable to this type of device.

The study described is a non-clinical performance test comparing the device to a predicate device, focusing on sterilization, shelf-life, biocompatibility, and physical characteristics. There is no mention of an algorithm or AI/ML components.

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