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3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESU'S) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY etc.). The 3M™ Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended applications could lead to an unsafe condition.

3M™ Universal Electrosurgical Pads, 9130 & 9160 have a green shaded coating technology that more uniformly distributes electrosurgical RF current over the whole conductive surface of the pad. The more uniform distribution technology and square shape permits universal orientation of the pad at a suitable placement site. The pad has a maximum temperature rise that is similar to pads up to 25% larger in conductor surface area. The entire surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolate the conductive area from surgical fluids.

The provided text describes the 3M™ Universal Electrosurgical Pads 9130 & 9160. Here's a breakdown of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the performance testing or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the devices meet the specified ANSI/AAMI standards.

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

This information is not provided in the document. The performance testing appears to be based on engineering and material standards rather than expert medical interpretation of images or patient data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (engineering performance standards), an adjudication method as typically described for clinical studies is unlikely to be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically for diagnostic imaging devices involving interpretation by multiple human readers, which is not relevant for an electrosurgical pad.

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

This concept is not applicable to an electrosurgical pad. The device's performance is standalone in the sense that its physical and electrical properties are tested, but it's not an "algorithm" or software that would normally be evaluated in a standalone manner for human interpretation. The testing described focuses on the device's inherent performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was the requirements outlined in the ANSI/AAMI HF18-1993 Voluntary Standards for Electrosurgical Devices. These standards define measurable physical and electrical parameters that electrosurgical pads must meet for safety and efficacy.

Additionally, for biocompatibility, the ground truth was "appropriate levels of Biocompatibility" as defined by tests selected on the basis of Part-1 of ISO 10993-1, "Biological Evaluation of Medical Devices."

8. The Sample Size for the Training Set

This information is not provided in the document. "Training set" is a concept typically associated with machine learning or AI models, which is not relevant for this device. The testing described is performance validation against established standards.

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

This information is not applicable as there is no "training set" in the context of an electrosurgical pad. The "ground truth" for evaluation was established by industry-wide voluntary standards (ANSI/AAMI HF18-1993) and international biocompatibility standards (ISO 10993-1), developed by expert committees in those fields over time.

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