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Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.

Electrosurgical disposable grounding pads construct of a layer of conductive aluminum foil with a foam as the supportive base of the pad. The aluminum foil is coated with adhesive hydro-gel layer. There is another film placed above the adhesive hydro-gel layer, which is used to protect the gel during the transportation and storage and will be removed prior to use.

They are available in different combinations of configurations, types, intended populations and conductive area.

They are not provided in sterile conditions and not required to be sterilized by the end user prior to operation. However, they are for single use only.

The provided text is a 510(k) summary for Electrosurgical Disposable Grounding Pads. This document is a regulatory submission to the FDA for a medical device and not a study proving the device meets acceptance criteria for an AI/ML powered device.

Therefore, many of the requested criteria related to AI/ML model performance evaluation (e.g., sample size for test/training sets, expert ground truth, MRMC study, human reader improvement, standalone performance, etc.) are not applicable to this document as it describes a physical, non-software medical device.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (bench testing) and biocompatibility, not through AI/ML performance metrics.

Here's a breakdown based on the provided document, addressing the applicable points and explaining why others are not applicable:

Acceptance Criteria and Study for Electrosurgical Disposable Grounding Pads

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" are derived from compliance with recognized medical device standards and demonstrating substantial equivalence to a predicate device. The "reported device performance" is its successful compliance with these standards.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the document. For non-clinical (bench) testing of physical devices, sample sizes are typically determined by engineering and statistical principles to ensure robust testing, but the explicit number of units tested is not provided in this regulatory summary.
• Data Provenance: The tests were non-clinical tests conducted to verify compliance with international standards (IEC, ISO). The location of the testing is not explicitly stated, but the company is based in China. The data would be prospective, as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a physical electrosurgical device, not an AI/ML model for which "ground truth" would be established by experts reviewing data (e.g., medical images). Ground truth for this device is based on objective measurements and compliance with engineering and safety standards.

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

• Not Applicable. This concept is relevant to expert review of data (e.g., medical images) to establish ground truth for AI/ML validation, not for the non-clinical testing of a physical medical device.

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

• Not Applicable. This device is a physical electrosurgical pad, not an AI/ML system, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not Applicable. This device is a physical electrosurgical pad, not an AI/ML algorithm.

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

• For this physical device, "ground truth" is established through objective measurements and compliance with recognized international standards (e.g., specified resistance limits, temperature rise limits, material compatibility, etc.) during non-clinical (bench) testing. There is no human interpretation of data for ground truth establishment as would be the case for an AI/ML diagnostic device.

8. The sample size for the training set

• Not Applicable. This device is a physical medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As no AI/ML model was developed, there was no training set and thus no ground truth established for it.

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