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The Henke-Sass, Wolf Resection Instruments are intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, incision, coagulation, cauterization of minor bleedings, resection of tissue, vaporization and enucleation, and as the surgeon deems appropriate. The instruments are intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:

• . Dilation of the urethra, and cold-slitting of urethral strictures
• . Trans-urethral incision and resection of the prostate
• . Trans-urethral removal of bladder tumor
• . Trans-cervical resection and ablation of the endometrium
• . Trans-cervical resection of fibroids

The Henke-Sass, Wolf Resection Instruments consist of various components that assemble into and/or work as a diagnostic and therapeutic resectoscopic system in urology and gynecology.
This submission is comprised of rigid working elements (resectoscopes), sheaths, obturators, electrodes (bipolar and monopolar), and HF cables. With the exception of the electrodes, the subject devices are provided non-sterile and reusable. The electrodes are provided sterile and are single-use.
Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.

This document is a 510(k) premarket notification for Henke-Sass, Wolf GmbH's HSW Resection Instruments. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a new AI-powered device meets specific performance acceptance criteria.

As such, there is no information in the provided text regarding acceptance criteria, AI device performance, sample sizes for AI test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth establishment for AI, or training set details.

The document describes a traditional medical device (resection instruments) and the non-clinical testing performed to establish its safety and effectiveness. This testing includes:

• Bench Testing: Visual inspection, resection setup mechanical functionality, leakage test and flow measurement, and functional tests for monopolar and bipolar electrodes.
• Sterility and Shelf Life: EtO sterilization validation, package integrity testing, transport validation, and accelerated aging testing for sterile electrodes (5-year shelf life). Reprocessing validation for reusable instruments (manual and automated cleaning, steam sterilization to achieve 10^-6 sterility assurance level).
• Conformance to Standards: Electrical safety (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-6, IEC 60601-2-18) and biocompatibility (ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation).

Therefore, I cannot fulfill your request for the specific information points related to AI device acceptance criteria and study details. The provided document does not pertain to an AI/ML-powered medical device.

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