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The st'rim™ fat tissue harvest and injection cannula set is intended for use in aesthetic body contouring.

The st'rim™ set consists of one tissue harvesting cannula, three injection (application) cannulas, two incision needles, all made of stainless steel, and a capped double-ended female Luer Lock connector for transfer of the fat tissue from the collection syringe to an injection syringe. The body contacting material is medical grade stainless steel and the contact duration is short-term. All components are provided in a preformed plastic tray. The set is a sterile, single-use device.

The provided document is a 510(k) premarket notification decision letter and summary for the "st'rim™" fat tissue harvest and injection cannula set. This document does not contain information about the acceptance criteria and study proving device performance in the context of an AI/ML powered device.

The document indicates that the device is a Class II medical device, product code MUU (Suction lipoplasty system). It describes its intended use, its components (cannulas, incision needles, connector), materials (stainless steel), and sterilization. It also outlines the testing performed for the device's Luer Lock connectors, packaging, sterilization, shelf life, and biocompatibility.

The "st'rim™" device is compared to a predicate device (K060089, Tulip Disposable Cannulas) and found to be substantially equivalent based on intended use, principles of operation, and materials, despite minor technological differences in cannula dimensions, coating, and sterilization methods.

Therefore, I cannot fulfill the request to describe the AI model's acceptance criteria and study details because this document pertains to a traditional medical device (cannulas) and does not involve AI/ML.

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