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This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators.

Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The device is intended to be used as a 24-month reusable patient return electrode for patients age 12 years and older. The Universal (model 0845) and Universal Plus (model 0847) have a single cord that connects to one generator. The Universal Dual (model 0846) and Universal Plus Dual (model 0848) have two cords that can connect to one or two generators.

The Mega Soft Universal Patient Return Electrodes (ie. Mega Soft) are constructed of a layer of conductive material strain-relieved between an insulative polymer gel, and sealed between two layers of a thermal polyurethane plastic film. The thermal polyurethane plastic film and the contained polymer gel enveloping the conductive material is compressable but does not laterally move under pressure. The polymer acts as a dielectric protection and is encapsulated by a layer of urethane film. The dielectric protection remains between the thermal polyurethane plastic film and the conductive layer irrespective of pressure.

A two-conductor cable connects the conductive layer of the device to a two-conductor DetachaCable™. The DetachaCable is connected to a standard monopolar ESU. The DetachaCable is available in a variety of configurations and lengths, designed to be compatible with the various compatible generators available on the market and was cleared under K080741 on 16 December 2008.

The provided document is a 510(k) summary for the Megadyne Patient Return Electrode Pads (models 0845, 0846, 0847, 0848). This document describes the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, ground truth establishment, or expert involvement as typically required for AI/ML device evaluations.

The reason for this is that the Megadyne Patient Return Electrode Pad is a physical medical device (an electrosurgical accessory), not a software or AI/ML algorithm. The performance data provided is related to electrical and mechanical properties, not diagnostic accuracy or AI performance metrics.

Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies for an AI device. This information is not relevant to the described device.

Instead, I can extract the acceptance criteria and study information that is applicable to this physical medical device:

Acceptance Criteria and Reported Device Performance (Physical Device)

Study Information (Physical Device Testing):

1. Sample size used for the test set and the data provenance: Not explicitly stated regarding specific numerical samples for each test parameter. The studies were bench performance testing and acute animal studies. Provenance typically refers to the origin of data; for bench testing, it's specific laboratory conditions, and for animal studies, it's a controlled animal model.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and animal model tests, not clinical evaluations requiring expert interpretation for ground truth. Compliance standards (IEC 60601 series) define the "ground truth" for success.
3. Adjudication method: Not applicable. This is not a clinical study involving human readers or AI output requiring adjudication.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable for this physical device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable for this physical device.
6. The type of ground truth used: For bench performance, the ground truth is defined by the technical specifications and safety standards (e.g., IEC 60601 series) that dictate acceptable electrical resistance, mechanical integrity, and cleaning effectiveness. For animal studies, the ground truth is the physiological response and absence of adverse events in the animal model, as per the standard (IEC 60601-2-2).
7. The sample size for the training set: Not applicable; there is no training set as this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

Summary from the document for this device:

The document primarily focuses on demonstrating substantial equivalence of the new Megadyne Patient Return Electrode Pads to a predicate device (Mega Soft Universal Patient Return Electrode, K133726 model 0845) based on identical technological characteristics (indications, materials, operational principles, packaging, shelf-life) and performance data from bench and acute animal studies. The differences identified (intended population, pad thickness, dual cord option, model number) were assessed through these tests to ensure they do not raise new questions of safety and effectiveness. The performance testing confirmed compliance with relevant IEC standards.

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