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NESSY Ω™ (Omega) disposable split return electrodes are intended for dispersing and monitoring HF current in electrosurgical interventions.

There are two models of the NESSY Ω™ (Omega) Disposable Split Return Electrode, One with a connecting cable (P/N: 20193-084) and the other (P/N: 20193-085) without the cable {Note: A reusable patient return electrode cable submitted in a previous ERBE 510(k) [K960569] is used with this plate/pad}. The cable of the P/N: 20193-084 is made of Polyvinvlcholoride (PVC). Copper Wiring, and Polyethylene (PE) Foam. It is flexible, 4 m (13.2 ft.) long, and has a standard connection for fitting into an ESU. The pad portion of each is made of Siliconized Polyethylene Terephthalate (PET). Scantape coated with Acrylic Adhesive, Aluminum, and Hydrogel. There is a protective film cover to keep the pad from drying out prior to being used. The Return Electrode has a peel off tab that makes handling it easier. The plate also is flexible and molds well to the skin. The relatively round external shape and geometrical internal omega design (i.e., the equipotential ring) of the pad more uniformly distributes the High Frequency (HF) current. This was demonstrated through thermographic testing. The design also eliminates the need for orientating the pad to the operative site (i.e., there is no long side of the pad). The hydrogel layer overlaps all the aluminum edges, which reduces warming of the pad during use. The Patient Plate is suitable for use on children and adults. The Electrodes are each packaged in an aluminum foil pouch with a 2-year expiration date. Also, they are provided non-sterile and are disposable.

The provided text describes a 510(k) summary for the NESSY Ω™ (Omega) Disposable Split Return Electrode. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the way a clinical trial for a novel AI device might.

Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set size) are not applicable or cannot be extracted from this type of regulatory submission. The document mainly outlines the device's technical specifications, intended use, and its similarities and differences to a legally marketed predicate device, along with the standards it met.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a new AI device. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to a predicate device by meeting relevant electrical safety and biocompatibility standards. The reported "performance" relates to how the new device achieves this equivalence.

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 provided in the 510(k) summary. The document mentions "thermographic testing" and "biocompatibility testing" but does not detail the sample sizes for these tests. In a 510(k) for a device like this, the focus is on engineering verification and validation against standards rather than large-scale clinical trials with specified clinical data provenance.

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 information is not provided and is generally not applicable to the type of device and regulatory submission described. "Ground truth" in this context would likely refer to established engineering standards or validated test methods, rather than expert clinical consensus on patient data.

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

This information is not provided and is not applicable to the engineering and bench testing described in the document.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the NESSY Ω™ electrode is.

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

This is not applicable as the NESSY Ω™ electrode is not an algorithm or AI-powered device. It is a physical medical device.

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

For the verification and validation tests mentioned, the "ground truth" would be based on:

• Established engineering standards: AAMI/ANSI HF-18, EN/IEC 60601-1, EN/IEC 60601-2-2 for electrical safety and performance.
• Biocompatibility testing against a standard: EN ISO 10993-1.
• Physical and thermal measurements: Thermographic testing for current distribution and warming, mechanical testing for flexibility and adhesion.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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