(88 days)
3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESUs) 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.). 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 green shaded coating technology that more uniformly distributes electrosurgical RF current over the whole conductive surface of 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 sufface area to isolate the conductive area from surgical fluids.
The provided text describes the 3M™ Universal Electrosurgical Pad (9130 & 9160) and its 510(k) summary, but it does not contain information about a study proving the device meets acceptance criteria.
The document states that "The 3M Universal Electrosurgical Pads meets the dispersive electrode performance standards of the voluntary ANSI/AAMI HF18-1993 for Electrosurgical Devices." This is a statement of compliance with a standard, not a description of a specific study or its results, nor does it provide detailed acceptance criteria that would include quantitative performance metrics.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or describe a study proving its conformance.
To answer your specific points based on the lack of information:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The document only states compliance with ANSI/AAMI HF18-1993.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
- 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): Not applicable, as no such study is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 an electrosurgical pad, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical pad, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no specific performance criteria or ground truth are described beyond meeting an industry standard.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.