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The resectoscope system devices are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and gynecological electrosurgical procedures.

The Resectoscope System from RZ Medizintechnik GmbH consists of a working element, a shaft and an electrode. The Resectoscope System is used during endoscopic surgery in the fields of urology and gynecology with an optical system for visualization. The electrode is inserted into the shaft for use and the shaft is connected to the working element.

The working element and shaft are supplied non-sterile, are intended for multiple use and must be sterilized before each use according to the instructions for use. The electrodes are supplied sterile and are intended for single use only.

To use the Resectoscope System, the electrosurgical unit, pump and light source must be connected to the working element via appropriate connections such as cables, tubing and light guide cables. These components are not part of this 510(K).

The provided FDA 510(k) Clearance Letter for the RZ Resectoscope System (K243382) details the process of demonstrating substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets specific acceptance criteria in the context of an AI-powered medical device or a device that relies on complex data-driven performance metrics for its primary function.

The RZ Resectoscope System is a traditional medical device (surgical tools – resectoscope, electrodes, sheaths, obturators) and its clearance is based on substantial equivalence to a predicate device (Henke-Sass Wolf Resection Instruments K173070) regarding its design, materials, intended use, and technological characteristics. The performance testing described is primarily bench testing to verify physical properties, functionality, and manufacturing quality, not a study involving AI assessment, human expert reads, or clinical outcomes data for a diagnostic/interpretive purpose.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI or advanced diagnostic studies, as the provided document does not contain any such details. The product is a physical surgical instrument, not an AI/software-as-a-medical-device.

However, I can extract the "acceptance criteria" and "device performance" as understood within the context of this traditional medical device 510(k) submission:

Acceptance Criteria and Device Performance (in the context of a traditional medical device 510(k) focusing on substantial equivalence):

For traditional medical devices seeking 510(k) clearance, "acceptance criteria" are typically met by demonstrating that the device is as safe and effective as a legally marketed predicate device. This is primarily achieved through comparative analysis of technological characteristics and non-clinical performance (bench) testing that confirms the device performs as intended and is safe for its stated Indications for Use.

Here's how the provided document addresses these concepts:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (for bench testing): The document states "all the products tested have passed the respective tests" for bench tests. It does not specify the sample size for these bench tests (e.g., how many units were visually inspected, leak tested, or subjected to mechanical force testing).
• Data Provenance: The RZ Medizintechnik GmbH is based in Tuttlingen, Germany. The tests conducted would presumably be internal company tests or performed by contracted labs, likely in Germany or Europe. The data is retrospective in the sense that it was generated prior to submission for clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This question is not applicable as this is a physical medical device clearance, not an AI/diagnostic device. There's no "ground truth" derived from expert reads of images or clinical data in the same way an AI device would require. Performance is established through engineering and physical property testing.

4. Adjudication Method for the Test Set

• Not applicable for the same reason as above. There are no "readers" or "adjudication" in the context of testing a surgical instrument's physical properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging or diagnostic AI devices to assess the impact of AI assistance on human reader performance. The RZ Resectoscope System is a surgical instrument.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This concept is only applicable to software algorithms. The RZ Resectoscope System is a physical device.

7. Type of Ground Truth Used

• Not applicable in the context of AI/diagnostic devices. For this traditional medical device, "ground truth" equates to established engineering specifications, material properties, functional requirements, and safety standards (e.g., does it leak? Does it withstand mechanical force? Is it biocompatible? Is it sterilizable?). These are verified through various bench tests and adherence to recognized standards.

8. Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, no training set or AI model is involved.

In summary, the FDA 510(k) clearance for the RZ Resectoscope System is based on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics, materials, and comprehensive non-clinical (bench) testing, rather than studies involving clinical data, human reader performance, or AI algorithms.

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