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Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system.

Specific indications:

• transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
• lysis of intrauterine septa -
• endometrial ablation -

The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft). The accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side.

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons. The electrodes have a shaft diameter of 24 Fr. range in length from 261.8-336.7mm, and range in compatibility with telescopes with a direction of view of 12° - 30°. The design of the HF cable plugs vary depending on which electrosurgical generator they are compatible with.

All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.

The provided document is a 510(k) summary for Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable (K171965). This is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a standalone clinical study involving acceptance criteria as typically understood for new major medical devices or AI algorithms.

Therefore, the acceptance criteria and study information typically requested for AI/ML performance are not present in this type of submission. This device is an accessory to electrosurgical units, and its substantial equivalence is primarily demonstrated through comparisons to predicate devices in terms of design, materials, indications for use, and adherence to recognized electrical safety and sterilization standards.

Here's how to interpret the available information against your request:

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

This document does not present "acceptance criteria" for device performance in the typical sense of a clinical outcome or diagnostic accuracy. Instead, it relies on demonstrating compliance with recognized standards and equivalence to a predicate device. The "reported device performance" refers to its ability to meet these standards and exhibit similar characteristics to the predicate.

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

This information is not applicable and therefore not provided in the 510(k) summary. The submission focuses on engineering and bench testing, not clinical performance data that would involve a "test set" in the context of AI/ML or clinical trials. The performance data relies on testing previously reviewed and deemed acceptable in K152092.

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 is not applicable to the type of device and submission. There is no "ground truth" to be established by clinical experts for the electrical safety, sterilization, or shelf-life testing of these electrodes.

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

This is not applicable for the reasons stated above.

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. This is a medical device accessory, not an AI/ML diagnostic or assistive tool.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

For the technical aspects (electrical safety, sterilization, shelf life), the "ground truth" is adherence to established international and national standards (e.g., ISO, AAMI/ANSI IEC standards) and validated engineering test results. For substantial equivalence, the "ground truth" is the previously cleared predicate device (K152092) and its established safety and effectiveness.

8. The sample size for the training set

This is not applicable. There is no software algorithm or AI model being trained for this device.

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

This is not applicable.

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