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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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Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator

Wandy Dispersive Electrode is designed to provide a safe return path Electrosurgical current between Generator, to active electrode and to patient without cord. And able to use to any patient if full skin contact available. non sterilized and to use only one time.

The surface of the conductive area is covered with a Bio-compatible Hydro-gel and the surface of the non-conductive area made of PE Foam and Texture Fabric is covered with Medical grade adhesive for maximum skin adhesion. This device are non sterilized and one time use only, available 3 sizes with various shape for Adult / Pediatric

The Wandy Dispersive Electrode is an electrosurgical grounding pad. The provided text, a 510(k) summary, details its safety and effectiveness for FDA clearance.

Here's an analysis of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance

Note: The provided 510(k) summary emphasizes equivalence to a predicate device and adherence to international standards. It references "attached reports" for biocompatibility and bench testing, but the actual data and detailed methodologies of these studies are not included in the provided text.

Study Information (Based on available text)

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated for any of the tests. The document refers to "Bench test done by manufacturer" and "Test Report attached" for biocompatibility, but no specifics on sample size are provided.
   • Data provenance: The tests were conducted by the manufacturer (Wandy Rubber Industrial Co., Ltd) in Taiwan, R.O.C., as indicated by the manufacturer's address. The data is retrospective in the sense that the tests were performed to support the 510(k) submission.

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

   • This is not applicable in the context of this device and submission. The "ground truth" for a medical device like a dispersive electrode is typically established through adherence to recognized international standards (e.g., ISO for biocompatibility, IEC for electrical safety), not through expert consensus on diagnostic images or clinical outcomes. The standards themselves define acceptance criteria.

3. Adjudication method for the test set:

   • Not applicable. The tests performed (biocompatibility, electrical safety) are objective measurements against defined criteria in international standards, not subjective assessments requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This is a therapeutic device (electrosurgical accessory), and such a study is not appropriate or required for its clearance.

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

   • Yes, in a way. The device's performance was evaluated in standalone bench tests according to specified standards (e.g., IEC for electrical performance, ISO for biocompatibility) without requiring human intervention in its primary function for the evaluation. These tests assess the device's inherent characteristics.

6. The type of ground truth used:

   • Standards-based performance criteria: For electrical safety, the ground truth is defined by the parameters and limits specified in IEC 60601-2-2. For biocompatibility, it's the criteria outlined in ISO 10993-1, ISO 10993-5, and ISO 10993-10. These are objective engineering and biological safety standards.
   • Comparison to predicate device: For technological characteristics like output power, the "ground truth" for substantial equivalence is the established performance of the legally marketed predicate device (K100686 Conmed Corp Macrolyte Dispersive Electrode).

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this device.

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The Ventlab Disposable Electrosurgical Pad is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Ventlab Corporation regarding their Disposable Electrosurgical Pad. This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report summarized for such a request.

Therefore, I cannot fulfill your request for the specific details outlined in the prompt from this document. The document primarily focuses on:

• The FDA's determination of substantial equivalence for the device.
• Regulatory requirements and general controls provisions.
• Instructions for marketing the device.
• Contact information for various FDA offices.
• The intended use of the device.

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