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The device is used for the endoscopic removal of biliary stones and foreign bodies.

The subject Disposable Stone Extraction Basket is comprised of a stainless steel/nitinol basket at the distal end of a sheath with handle. Basket is advanced out of and retracted into the single lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter. EO Sterilization and use for single use only.

The provided text is a 510(k) summary for the Disposable Stone Extraction Basket. It describes the device, its intended use, and compares it to a predicate device. However, it does not include detailed acceptance criteria or the specifics of a study proving the device meets those criteria, especially not in the context of an AI/ML powered device.

The document discusses performance data broadly in Section 5.8: "The Disposable Stone Extraction Basket meets all device standards for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This refers to general device safety and functionality standards, not specific performance metrics related to diagnostic accuracy, sensitivity, or specificity that would be typical for an AI/ML powered medical device.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving its performance for an AI/ML powered device based on the given text. The device described is a physical medical device (stone extraction basket), not an AI/ML algorithm.

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