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The ReNew XR Handpieces and tips are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic procedures.

The ReNew XR Handpiece is also indicated for reference length measurement of tissue during endoscopic and laparoscopic surgical procedures.

The ReNew XR Handpiece with Reference Markings is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, graspers, and dissectors (all of which are outside of the scope of this submission). It is indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic procedures and it is also indicated for reference length measurement of tissue during endoscopic surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece with Reference Markings is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece with Reference Markings does not produce energy but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such a generator, the ReNew XR Handpiece with Reference Markings delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a handheld active electrosurgical generator through a return electrode attached to the patient is part of the electrical circuit. The Relew XR Handpiece with Reference Markings can be used with a legally marketed third party electro-surgical high frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements. After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use.

Like the predicate device, the subject devices are made of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly.

Variations of the subject devices include varying handle length and presence of a ratcheting mechanism.

The provided text describes a 510(k) premarket notification for electrosurgical handpieces. It outlines the device, its intended use, and comparisons to a predicate device. However, it does not contain the specific information required to answer your questions about acceptance criteria for an AI/ML powered device, its performance against those criteria, or details regarding study design for evaluating such a device.

The product in question, the "ReNew XR Handpiece," is a mechanical surgical instrument, not an AI/ML powered device. The document focuses on regulatory compliance for a medical device that facilitates laparoscopic surgeries, including reference length measurement.

Therefore, I cannot extract the information you requested about acceptance criteria, study details, and ground truth for an AI/ML powered device from the provided text.

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