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The Stryker Urology and Gynecology Hardware System is 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, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is 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 tumors

Trans-cervical resection and ablation of the endometrium

Trans-cervical resection of fibroids

The Stryker Urology and Gynecology Hardware System is composed of endoscopes, sheaths, accessories, and applied parts which provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that comprehensively proves the device's performance against such criteria. The document is a 510(k) summary for a medical device (Stryker Urology and Gynecology Hardware System) seeking substantial equivalence to existing devices.

Here's what the document does include and why it doesn't meet the request:

• Device Description and Intended Use: It describes the device, its components, and its intended uses in diagnostic and therapeutic surgical procedures.
• Predicate Devices: It identifies predicate devices to which the Stryker system claims substantial equivalence.
• Performance Standards: It lists several IEC and ISO performance standards (e.g., IEC 60601-1, ISO 10993) to which the device conforms for safety and biological evaluation. However, these are general compliance standards, not specific acceptance criteria for a performance study.
• Substantial Equivalence Claim: The core of a 510(k) submission is the claim of substantial equivalence to a legally marketed predicate device, rather than a detailed performance study proving specific acceptance criteria in the way you've requested.
• FDA Clearance Letter: The letter indicates that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This decision is based on the information provided in the 510(k) summary, which in this case emphasizes equivalence rather than a separate, detailed performance study with outlined acceptance criteria.

Therefore, I cannot provide the requested table and study details because the input document does not contain:

1. A table of specific acceptance criteria.
2. Reported device performance against such criteria.
3. Details about sample sizes for test sets, data provenance.
4. Information on experts, adjudication methods for ground truth.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone algorithm performance study.
7. Details about the type of ground truth used in a performance study.
8. Sample size for a training set or how its ground truth was established, as this device does not appear to be an AI/ML type device requiring such training.

The document focuses on regulatory clearance through substantial equivalence, which primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through design comparison, material biocompatibility, and adherence to general safety standards, rather than new, extensive head-to-head performance studies with detailed acceptance criteria and expert-adjudicated ground truth.

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