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The REM Polyhesive Infant Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its complete the electrosurgical circuit between the generator, the active electrode, and the patient.

The product is used for general monopoloar electrosurgery on newborns, infants, and children weighing between approximately 6 and 30 lb.

Device Description

The Valleylab™ REM Polyhesive™ Infant Patient Return Electrodes are part of a family of patient return electrodes. They are non-sterile, single-use devices used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The infant return electrodes are designed to be compatible with the return electrode monitoring function of compatible Covidien generators.

There are two separate catalog numbers for the infant Polyhesive™ return electrodes. The two models differ only with regard to the length of the cord connecting the return electrode to the generator. One has a 9-foot cord and the other has a 15-foot cord.

AI/ML Overview

The provided FDA 510(k) document for the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing related to safety and effectiveness, rather than a diagnostic accuracy study for an AI-powered device. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and data provenance) are not directly applicable or available in this type of submission.

However, I can extract information regarding the acceptance criteria and studies mentioned for the device's performance related to its intended use and safety.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode are primarily based on meeting the requirements of recognized international electrical safety and performance standards. The document states that the device demonstrated appropriate performance by meeting applicable clauses within these standards.

Acceptance Criteria Category	Source/Standard	Reported Device Performance
Thermal Performance	The impact of differences (higher patient weight range, larger surface area compared to predicate) was evaluated through testing. The device is expected to carry more current due to the higher weight range. The standard IEC 60601-2-2: 2009 (Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) contains clauses related to thermal performance of patient return electrodes. Specific acceptance criteria (e.g., maximum temperature rise) are implied by adherence to this standard.	The infant return electrode has a larger surface area than the neonatal return electrode to accommodate the higher patient weight range. Testing was performed "to show that the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode meets thermal performance requirements for return electrodes indicated for use on patients weighing between 5 and 15 kg." The specific thermal performance results (e.g., actual temperature readings) are not explicitly stated but are implied to have met the necessary criteria for regulatory clearance. The phrase "meets thermal performance requirements" suggests compliance.
Shelf Life Performance	Verification in accordance with sub-clause 201.15.101.8 of IEC 60601-2-2: 2009, which requires products to be aged to within 30 days of their expiration date prior to thermal performance and contact impedance testing. Additionally, primary packaging integrity is assessed.	The packaged devices have a shelf life of two years. "Suitability of this shelf life has been verified" according to the specified IEC standard. The "primary packaging remains intact with no tears, holes, or other degradation and the seal remains intact (seal width maintained and no visual evidence of seal degradation)."
Biocompatibility	Evaluation in accordance with ISO 10993-1:2009 and the FDA Blue Book Memorandum G95-1. Acceptance criteria for cytotoxicity, sensitization, and primary skin irritation tests.	Production-representative devices were subjected to cytotoxicity, sensitization, and primary skin irritation tests. "The devices met all of the acceptance criteria for these tests." This confirms the materials in contact with the patient are safe for their intended use duration.
Electrical Safety and Essential Performance	IEC 60601-1: 2005 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) and IEC 60601-2-2: 2009 (Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). Specific clauses within these standards define acceptable levels of electrical safety, performance of the REM system, and current distribution.	"Appropriate performance...was demonstrated by showing that the device meets applicable clauses" in these standards. This indicates that all relevant safety and essential performance parameters, including those related to the REM system (preventing unintended RF burns by ensuring a low-impedance path and contact quality monitoring), were tested and found to be compliant.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2: 2007 and 2014 (Medical Electrical Equipment – Part 1-2: General requirements for safety – Collateral Standard: Electromagnetic compatibility – Requirements and Tests). These standards define limits for electromagnetic emissions and immunity to ensure the device operates correctly in its environment without causing interference or being affected by it.	"Appropriate performance...was demonstrated by showing that the device meets applicable clauses" in these standards. This implies that the device passed all required EMC tests, ensuring it functions safely and effectively without electromagnetic interference.

Since this is a submission for a medical device (patient return electrode) and not an AI/diagnostic software, the following sections from your request are not applicable or not provided in the document:

Sample sizes used for the test set and the data provenance: Not applicable. These are not diagnostic accuracy studies. Performance testing is usually conducted on a set number of samples required by the standards, not a "test set" in the context of an AI model. Data provenance (country, retrospective/prospective) is also not relevant here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI models (e.g., expert labels on images) is not relevant for this type of device testing.
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 is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is compliance with established international safety and performance standards (e.g., IEC, ISO).
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

In summary, the substantial equivalence assertion for the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode is based on demonstrating that its design and materials, despite minor differences in patient weight range and surface area from the predicate, meet required performance and safety standards for medical electrosurgery devices.

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