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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.

Device Description

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°

AI/ML Overview

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.

Acceptance Criterion	Standard/Requirement	Reported Device Performance
Thermal Safety	IEC 60601-2-18	Results show that thermal hazards may be excluded if the devices are used according to their indications.
Electrical Safety	IEC 60601-2-18	Results indicate electrical safety of the devices as required per respective standard.
Optical Performance	Internal final inspection	Every device is checked for optical performance before final release.
Sterilization	ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665, EN ISO 17664	Safety and efficiency of the specified sterilization cycle has been validated under consideration of the requirements.
Biocompatibility	DIN EN ISO 10993-1	Provides evidence on acceptable levels of biocompatibility.
Substantial Equivalence	N/A (Comparative analysis)	Spinal Endoscopes are considered substantially equivalent to predicate devices in terms of indications for use, material, technology, design and performance specifications. No new issues of safety or effectiveness.

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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