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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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The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not mantain a state of normothermia. The System can be used with adult patients.

The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors.

The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The HotDog Return Electrode Mattress is intended for use with adult patients only.

The HotDog Warming Mattress + Return Electrode (“Mattress") is part of a thermal regulating system, indicated for controlling patient temperature in adult patients.

Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings.

Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.

The provided text describes a 510(k) premarket notification for the "HotDog Warming Mattress + Return Electrode." This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than performance data derived from an AI/ML-based device that would require a study with acceptance criteria, a test set, and human expert adjudication.

Therefore, the requested information, specifically regarding "AI vs without AI assistance," "standalone performance," "human readers," "ground truth," training/test sets, and expert consensus, is not applicable to this document as it pertains to a physical medical device (warming mattress and return electrode) and not an AI/ML diagnostic or therapeutic device.

The document discusses bench testing to demonstrate compliance with FDA-recognized consensus standards and to show substantial equivalence to the predicate device.

Here's a summary of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria with quantifiable metrics for a "device performance" in the way one would for an AI/ML diagnostic. Instead, it describes compliance with recognized consensus standards and general safety/performance characteristics.

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

• Sample Size: Not applicable in the context of clinical data or AI/ML testing. The "tests" here refer to bench tests on the physical device. The document does not specify the number of devices or test conditions for the bench testing beyond stating "bench testing was performed."
• Data Provenance: The bench testing was "underwritten by Intertek." This implies a third-party laboratory conducted the tests. The document does not specify the country of origin of the data beyond this. It's a retrospective assessment of the device's characteristics against predefined standards.

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

• Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for this physical device's regulatory review. The "truth" is established by compliance with engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is a bench test evaluation, not a clinical study involving reader performance and adjudication.

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 does not involve AI or human reader assistance.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's evaluation is adherence to recognized consensus standards for medical electrical equipment safety, electromagnetic compatibility, thermal regulation, and electrosurgical accessories. This is established through established engineering and testing methodologies, not clinical expert consensus on specific cases.

8. The sample size for the training set:

• Not applicable. There is no AI/ML model being trained.

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

• Not applicable. There is no AI/ML model being trained.

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OKLand Patient Return Electrode Pad 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 in monopolar surgery.

This device is restricted to use with isolated monopolar electrosurgical generators, not intended for radio frequency ablation.

The device consists of a layer of conductive Copper-Nickel fibbers-coated polyester mesh, encased in a viscoelastic and dielectric polyurethane (PU) gel. These two materials are wrapped and sealed with PU membrane. A (or two) BVR lead (s) is attached outside of the pad, one side of the lead is connected to the conductive mesh, and the other side of the lead is assembled with different kinds of connectors.

This device should be operated by qualified healthcare personnel and is intended to be used for patients with a body weight no less than 0.35 kg (0.81b). , with no upper body weight limit.

The provided text is a 510(k) summary for the OKLand Patient Return Electrode Pad. Within this document, the manufacturer demonstrates the device's substantial equivalence to predicate devices, focusing on technological characteristics and non-clinical performance data.

However, the provided text does not contain information about acceptance criteria or a study that uses a test set, expert readers, or ground truth for evaluating performance metrics like sensitivity, specificity, accuracy, or AUC. Instead, the performance data presented is related to biocompatibility, electrical safety and compatibility, and bench performance tests, which are typical for an electrosurgical accessory.

Specifically, the document states:

• "No clinical data is presented in this submission" (page 5, "Clinical Studies" section). This indicates that the type of study typically involving human-in-the-loop performance, multi-reader multi-case studies, or direct clinical outcomes to establish AI performance metrics is not applicable here.
• The "Bench Performance Test" section mentions that "Performance testing was conducted as recommended by the FDA guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery to support substantial equivalence to the predicate device." It concludes that "The results demonstrated the subject device can perform the intended use as safe and effective as the predicate device." This refers to engineering and lab-based testing, not clinical performance or AI algorithm validation with a test set and ground truth.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device meets those criteria using expert readers and ground truth data, as the nature of this device (an electrosurgical return electrode pad) and the provided 510(k) summary do not involve such a study design. The device approval relies on demonstrating equivalence through non-clinical testing for safety and performance (e.g., electrical safety, biocompatibility, and bench testing).

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