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This device is indicated for use in conjunction with an endoscope in the gastrointestinal tract for tissue or foreign body manipulation and/or where multiple removal and insertions of an endoscope are required.

The ORISE Tissue Retractor System is comprised of the ORISE Tissue Retractor (OTR) consisting of the handle, the flexible shaft with expandable distal end (chamber) and the associated instrument guides called the ORISE Instrument Guides (OIGs) which are flexible conduits, guiding other instruments such as graspers. The OIG is available in three (3) tip configurations; with 45°, 60° and 90° tip bend angles. Shaft Markers are used for reference purposes for aid in placing the retractor.

The provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of an AI/ML-based medical device.

The document is a 510(k) premarket notification for the ORISE™ Tissue Retractor System, which is a physical medical device (an endoscope accessory), not an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the content provided.

The document discusses:

• Acceptance Criteria for the ORISE™ Tissue Retractor System: This is inferred from the "Performance Data" section (Section 7). The device underwent "Functional and performance tests" to demonstrate "substantial equivalence" and satisfy "design verification requirements." It "passed all tests." Specific tests mentioned include "OTR and OIG dimensional testing, OTR and OIG performance testing including simulated use testing, Tensile strength testing, OTR scope compatibility, OIG instrument compatibility and OTR/OIG compatibility." Biocompatibility testing was also performed and passed.
• Study Proving Acceptance: The "Bench Testing" and "Biocompatibility Testing" sections describe the studies. These are laboratory-based tests rather than clinical studies with human participants for performance evaluation in the way an AI/ML device would be evaluated.

To directly answer your questions based only on the provided text, many fields would be "Not Applicable" or "Information Not Provided" as they pertain to AI/ML device evaluation, not a physical medical device like the ORISE™ Tissue Retractor System.

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