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HF cable for electrotherapeutical use in endoscopic procedures in conjunction with compatible active accessories and compatible electrosurgical units.

The Olympus monopolar single-use HF cable that is subject to this submission connects a compatible electrosurgical generator with the working element of a resectoscope for the application of monopolar HF current during endoscopic procedures.

The HF cable is delivered in sterile condition and is intended for single use only.

The monopolar single-use HF cable consists of a proximal plug connecting to the HF generator, an insulated cord and a distal plug connecting to the working element of the resectoscope.

The provided text describes a 510(k) premarket notification for a Monopolar Single-use HF Cable. This document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.

However, based on the information provided, I can extract the closest parallels to your request:

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

The document lists performance tests conducted to demonstrate safety and effectiveness. These tests implicitly serve as acceptance criteria, meaning the device had to pass these tests to be considered substantially equivalent. The "reported device performance" is essentially that the device passed all these tests, thereby meeting the implied acceptance criteria. Specific quantitative results are not provided in this summary.

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

The document does not specify the sample sizes for the individual performance tests. It mentions "Conducting tests included the following tests," implying that the device (or samples of the device) underwent these tests. The provenance of the data is from Germany (Olympus Winter & Ibe GmbH, Hamburg, Germany) where the manufacturer is located and presumably where the tests were performed. The nature of these tests (e.g., electrical, mechanical, sterilization) is typically prospective testing of manufactured devices or prototypes, rather than retrospective data analysis.

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)

This type of information is not applicable to the described device and study. The "ground truth" for this medical device (a cable) is established through engineering and laboratory performance testing against recognized standards, not through expert consensus on medical images or clinical outcomes.

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

This information is not applicable as there is no human interpretation or adjudication of outputs in the context of these device performance tests. The tests are objective measurements against predefined engineering standards.

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

This is not applicable. The device is an HF cable, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This is not applicable. The device is a physical medical accessory (a cable), not an algorithm. Standalone performance testing refers to the device's ability to meet its specifications independently, which is what the listed performance tests generally evaluate.

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

The "ground truth" for this device's performance is derived from international and national recognized standards for medical electrical equipment (e.g., AAMI/ANSI ES 60601-1, IEC 60601-2-2, IEC 60601-1-2) and specific ISO standards for sterilization and packaging (ISO 11135, AAMI ANSI ISO 11607-1:2006). This includes objective measurements of electrical safety, mechanical durability, and sterilization effectiveness against predefined limits set by these standards.

8. The sample size for the training set

This is not applicable. The device is a physical medical accessory, not an AI model that requires a training set.

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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