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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, 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, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis), lysis of intrauterine septa, endometrial ablation.

The Olympus Resection Electrodes with HF cable that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting. 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 tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket. 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.

This document is a 510(k) Premarket Notification from the FDA regarding Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable. It describes the device, its intended use, and its equivalence to a predicate device.

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

The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as this is a traditional medical device (electrodes) rather than a diagnostic device or AI algorithm with such measures. Instead, the acceptance criteria are based on demonstrating comparable safety and effectiveness to the predicate device through various non-clinical performance and safety tests, and compliance with relevant standards.

Here's a summary of the performed tests as evidence of meeting safety and effectiveness requirements:

The study concluded that "The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device."

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

The document describes non-clinical performance and safety testing. It does not refer to "test sets" in the context of patient data. The samples for testing would be units of the device itself (electrodes and cables). The specific number of devices tested for each non-clinical test (e.g., how many electrodes were subjected to lifetime connection/disconnection tests) is not explicitly stated in this summary.

The provenance of this data is from regulatory submissions to the FDA, originating from the manufacturer, Olympus Winter & Ibe GmbH, which is located in Hamburg, Germany. The tests are non-clinical (laboratory/bench tests), not clinical studies; therefore, terms like retrospective/prospective or country of origin of patient data are not applicable.

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 as the document describes non-clinical testing for a traditional medical device (electrosurgical electrodes and cables), not a diagnostic device or AI algorithm requiring expert-established ground truth from patient data.

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 for the reasons stated above. The device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.

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

This is not applicable for the reasons stated above. The device is a physical electrosurgical electrode and cable, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" or reference for evaluating performance is typically defined by:

• Engineering specifications and design requirements: For mechanical, electrical, and functional performance.
• Applicable national and international standards: For electrical safety (e.g., IEC 60601 series), sterilization (ISO 11135), packaging (ISO 11607-1, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and biocompatibility (ISO 10993 series).
• Comparison to the predicate device: The goal is to demonstrate that the subject device is substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. The device is a traditional medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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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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