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The Soniquence Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Soniquence Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.

The Soniquence Reusable Neutral Plates will be provided as a flexible plate made of silicone rubber and will be supplied with a 10-foot cable and is non-sterile. There are no differences in the functionality of the reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.

Acceptance Criteria and Study for Soniquence Reusable Neutral Plate

This document describes the acceptance criteria and the study performed to demonstrate that the Soniquence Reusable Neutral Plate meets these criteria, as derived from the provided 510(k) summary.

The Soniquence Reusable Neutral Plate is an electrosurgical accessory, not a diagnostic AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of device and its regulatory clearance process. The primary method for demonstrating safety and effectiveness for such a device is through non-clinical performance and biocompatibility testing against recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Soniquence Reusable Neutral Plate are based on compliance with an recognized international standard (IEC 60601-2-2) and biocompatibility standards (ISO 10993-5:2010 and ISO 10993-10:2010), demonstrating its safety and performance aspects.

2. Sample Size Used for the Test Set and Data Provenance

For electrosurgical accessories like the Soniquence Reusable Neutral Plate, the "test set" typically refers to the manufactured units or representative samples of the device undergoing non-clinical bench testing. The 510(k) summary does not specify the exact number of devices tested for compliance with IEC 60601-2-2 and ISO 10993 standards. However, industry practice for such testing involves a sufficient number of samples to ensure robust and representative results, often dictated by the specific test protocol requirements within the standards. The data provenance is from non-clinical bench testing rather than human subject data, and thus there is no country of origin or retrospective/prospective distinction in the context of clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This category is not applicable as the device is not an AI/ML diagnostic tool. Ground truth for an electrosurgical neutral plate is established through objective physical and electrical measurements and chemical analyses conducted according to international standards for safety and biocompatibility. The "experts" involved would be qualified test engineers and laboratory personnel with expertise in electrosurgical device testing and biocompatibility assessment, following the methodologies prescribed by IEC and ISO standards.

4. Adjudication Method for the Test Set

This category is not applicable as the clearance is based on objective, quantifiable non-clinical and biocompatibility test results, not subjective interpretations by experts that would require adjudication.

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 category is not applicable. The Soniquence Reusable Neutral Plate is an electrosurgical accessory, not an AI/ML algorithm or a device that assists human readers in medical image interpretation.

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

This category is not applicable. The Soniquence Reusable Neutral Plate is a physical electrosurgical accessory, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for the Soniquence Reusable Neutral Plate is objective physical and electrical measurements and chemical analyses as defined by the referenced international standards:

• IEC 60601-2-2:2017 provides the methodologies and acceptance criteria for electrical safety and performance of electrosurgical equipment and accessories.
• ISO 10993-5:2010 (Cytotoxicity) and ISO 10993-10:2010 (Sensitization and Irritation) provide the methodologies and acceptance criteria for evaluating the biocompatibility of medical devices.

8. The Sample Size for the Training Set

This category is not applicable. The device is not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established

This category is not applicable. The device is not an AI/ML algorithm and therefore does not have a "training set."

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