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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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The use of RZ Medizintechnik spinal endoscopes is indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.

The Cervical Endoscopes of RZ Medizintechnik are optical and fiberoptic-based rigid endoscopes provided with working channels of 2.2mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the cervical spine.

The Discoscopes of RZ Medizintechnik are optical and fiberoptic based rigid endoscopes provided with working channels of 2.8 mm. 3.75 mm and 4.3 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the spinal column such as endoscopic assisted discectomy.

The Spinal endoscopes of RZ Medizintechnik may be attached to standard fiberoptic lightsources, commonly available video adapters and cameras such as Storz, Olympus and Wolf.

The devices are reusable, delivered in non-sterile conditions and available in various designs:

• Outer Diameters from 3,6 mm to 7,0 mm .
• Diameter of working channel from 2,2 mm to 4,3 mm .
• Working length from 95 mm to 208 mm .
• Direction of view: 0°/6° (cervical endoscope) , 30° (discoscopes) .
• Viewing angle 80° +- 5°

The RZ Medizintechnik Spinal Endoscopes are a Class II medical device (product code HRX) regulated under 21 CFR 888.1110 (Arthroscope). The device is intended for use in spinal endoscopic procedures and minimally invasive surgery to view the intraoperative site.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes various tests performed to demonstrate the safety and effectiveness of the RZ Medizintechnik Spinal Endoscopes. The acceptance criteria are implicitly defined by the standards to which the tests were conducted.

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

The document does not explicitly state the sample size (number of devices) used for each specific test (thermal safety, electrical safety, biocompatibility, sterilization validation). However, it mentions "greatest challenge devices" were used for biocompatibility testing, implying a representative selection.

The provenance of the data is internal testing performed by RZ Medizintechnik in Germany. The studies appear to be prospective, as they were conducted specifically for this 510(k) submission.

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

This information is not provided in the document. The studies performed are primarily engineering and laboratory tests based on recognized standards, rather than clinical studies requiring expert interpretation of ground truth in a diagnostic or clinical context.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving multiple readers for diagnostic accuracy assessments. This information is not applicable/not provided as the submission details laboratory and technical performance testing, not a multi-reader clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an endoscope, a tool used by surgeons; it is not an AI-powered diagnostic or assistive technology that would involve a comparison of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a surgical endoscope, not an algorithm, and intrinsically involves human-in-the-loop performance (a surgeon using the device).

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is established by the specifications defined in the referenced consensus standards (IEC 60601-2-18, ANSI/AAMI ST81, etc.). For example:

• Thermal Safety: "Ground truth" is the acceptable temperature limits defined by IEC 60601-2-18.
• Electrical Safety: "Ground truth" is the acceptable electrical safety parameters defined by IEC 60601-2-18.
• Optical Performance: "Ground truth" is likely internal design specifications and visual inspection criteria.
• Sterilization: "Ground truth" is the achievement of sterility assurance levels as defined by the sterilization validation standards.
• Biocompatibility: "Ground truth" is the acceptable levels of biological response as defined by DIN EN ISO 10993-1.

8. The Sample Size for the Training Set

This is not applicable. The RZ Medizintechnik Spinal Endoscopes are physical devices, not an AI or machine learning algorithm, and therefore do not have a "training set" in the computational sense.

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

This is not applicable for the same reason as point 8.

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RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and include both electrical and non-electrical accessories.

RZ Endoscopic (Minimally Invasive) Instruments and Accessories consist of 1. Modular Forceps (reusable) 2. Single-Piece Forceps 3. Modular Forceps with Disposable Tips 4. Electrodes 5. Resectoscopic Instruments & Electrodes (reusable & disposable) 6. Electrosurgical Cables

The provided text is a 510(k) Summary for "RZ Endoscopic (Minimally Invasive) Instruments and Accessories". It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states: "Performance Data: Testing was performed to support substantial equivalence to the predicate devices. The RZ Endoscopic (Minimally Invasive) Instruments and Accessories met all specified design and performance requirements." This is a general statement that confirms performance testing was done and the device passed, but it does not provide any specific details about:

1. A table of acceptance criteria and the reported device performance: No specific metrics, thresholds, or results are presented.
2. Sample size used for the test set and the data provenance: No information on how many devices were tested or where the test data came from.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is for medical image analysis or diagnostic devices, not surgical instruments. The "ground truth" for surgical instruments typically involves engineering specifications and direct performance measurements (e.g., tensile strength, insulation integrity, cutting efficiency).
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance study (algorithm only): Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Implied to be engineering specifications and functional testing, but not explicitly detailed.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to establish substantial equivalence to predicate devices based on design and general performance requirements, not to detail the specific performance criteria and study results in the manner requested for AI/ML or diagnostic devices.

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