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The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical nrocedures .

The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.

The cystoscopes and accessories are used for visualizing body cavities and organs (via natural pessages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the scope s working channel.

The instruments are reusable; they are intended to be cleaned, sterilized and reused.

The Trokamed GmbH Endoscopes and accessories consist of:

• A Various manually operated surgical instruments
• A Several Trocar sleeves and accessories, Verres insufflation cannula and suction-firrigation systems

• Several Endoscopes (Arthroscope, Cystoscope)

The provided document is a 510(k) summary for Endoscopes and accessories by Trokamed GmbH. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in this document. This document is a regulatory submission, not a research study report.

However, I can extract the following relevant information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity). Instead, the "acceptance criteria" for regulatory approval are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices.

The "reported device performance" is not expressed in quantitative metrics in this document. The performance is implied to be equivalent to the predicate devices based on design and intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The document does not describe a clinical study with a test set of data. The assessment is based on a comparison to predicate devices and adherence to standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. No test set with ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. No test set or adjudication method is described.

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

• Not applicable / Not provided. This device is an endoscope, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not provided. As stated above, this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. The concept of "ground truth" for a performance study is not addressed for this type of device submission. The primary ground for approval is substantial equivalence to existing devices.

8. The sample size for the training set

• Not applicable / Not provided. This document does not describe a machine learning algorithm or a training set.

9. How the ground truth for the training set was established

• Not applicable / Not provided.

Summary of available information related to performance/safety demonstration:

The document indicates that the device meets safety and effectiveness requirements by:

• Substantial Equivalence: Listing several predicate devices by other manufacturers (Richard Wolf, Hans Hermann, Ackermann) with similar intended uses and design. This is the primary "proof" of meeting regulatory acceptance criteria.
• Biocompatibility: Stating that "The biocompatibility has been approved based on ISO 10993 parts one, five and ten by the accredited Laboratory Bioservice." This implies a study was done by an accredited lab to these ISO standards, with the internal acceptance criteria of those standards being met. However, the specific results or parameters are not detailed.
• Sterilization by User: Providing recommendations for sterilization (steam-sterilizer at 134°C / 270°F, 3 bar, for 10 minutes), implying that the device is designed to withstand and be effectively sterilized by such methods. This would have been validated internally by the manufacturer, but the validation study details are not provided in this summary.

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