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The Mega 2000 Soft Dual Cord Patient Return Electrode Pad is to be used as a general purpose return electrode for one or two electrosurgical generators and/or a pressure reduction pad, in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.

The Mega 2000 Soft Dual Cord is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric layers of a viscoelastic polymer. (The top layer of polymer is thinner than the bottom layer.) The polymer is encapsulated by a layer of urethane film. Two cables connect the conductive layer of the device to two DetachaCables". The DetachaCable(s) are connected to a standard monopolar electrosurgical unit (ESU). The device cables are insulated and strain-relieved well inside the device to prevent patient or user burns. The device is large enough to extend at least the length and width of a typical patient torso. Pad size is approximately 20" x 46" x ½". In use, this device will lay on an operating room table with the patient lying on top, on the side labeled "patient side".

The provided text describes a 510(k) premarket notification for the "Mega 2000 Soft Dual Cord Patient Return Electrode Pad." This document focuses on demonstrating substantial equivalence to a predicate device and safety and performance testing for a medical device that assists in electrosurgery. It is not an AI/ML device, so many of the requested categories (e.g., training set, MRMC study, ground truth for training set) are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Mega 2000 Soft Patient Return Electrode Pad is to be used as a general purpose return electrode and/or a pressure reduction pad in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.

The Mega 2000 Soft Patient Return Electrode Pad is constructed of a layer of viscoelastic polymer called Akton®, sealed between two asymmetric layers of urethane material, and a conductive material strain-relieved inside the device. (The top layer of polymer is thinner than the bottom layer, approximately 1.0000m layer.) The Akton polymer is encapsulated by a layer of urethane. A two conductor DetachaCable™ connects the conductive layer of the device to a standard electrosurgical generator. The DetachaCable is connected to a strain-relieved well inside the device to prevent patient or user burns. The device is large enough to extend at least the length and width of a typical operating room table, approximately 20" x 46" x ½". In use, this device will lay on an operating room table with the patient lying on top, on the side labeled "patient side".

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mega 2000 Soft Patient Return Electrode Pad (K021077).

Important Note: The provided 510(k) summary (K021077) for the Mega 2000 Soft Patient Return Electrode Pad heavily relies on demonstrating equivalence to predicate devices rather than independent performance testing against strict acceptance criteria. This is typical for Class II devices seeking 510(k) clearance where substantial equivalence is the primary pathway. Therefore, the information you're looking for regarding explicit acceptance criteria and a detailed study proving performance against them is largely absent in this specific document. The "study" mentioned is primarily a series of safety and performance tests to ensure the device performs as intended and is equivalent to the predicate, rather than a clinical trial with statistical endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, explicit numerical acceptance criteria, as might be found in a clinical trial to prove a specific efficacy, are not detailed in this 510(k) summary. The "acceptance criteria" here are largely implied by compliance with standards and demonstration of equivalent functional performance and safety to predicate devices.

• Prevent patient/user burns
• Return electrode monitoring (

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The MegaDyne Mega 2000™ reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.

The MegaDyne Mega 2000™ reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. A two conductor cable to connect the device to a standard monopolar electrosurgical unit (ESU) is connected to the conductive layer of the electrode. This cable is insulated and strain-relieved well inside the device to prevent possible patient or user burns. The electrode is approximately 20'' x 36". This size is large enough to extend at least half the length and full width of the typical patient torso. The device is not intended to be attached to the patient. A clear plastic sheath is placed over the device. This sheath, which is replaced at a minimum each day, provides a second layer of dielectric protection.

This document is a 510(k) summary for the MegaDyne Mega 2000™ reusable patient return electrode. It outlines the device's description, intended use, and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a clinical study with a test set in the conventional sense for a medical imaging or diagnostic device. The evaluation presented here is for an electrosurgical patient return electrode, focusing on electrical safety and functional characteristics, primarily through design specifications and conformance to standards. Therefore, information about a "test set" sample size or data provenance (country, retrospective/prospective) for a clinical performance study is not applicable to this submission. The "testing" appears to be engineering design and validation focused on achieving specific electrical and safety parameters.

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

Not applicable. As noted above, this submission does not describe a clinical study involving experts establishing ground truth for a test set. The safety and functional claims are based on engineering design, specified current densities, and expected adherence to industry standards.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as no clinical test set requiring expert adjudication is described.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, and the document describes an electrosurgical patient return electrode.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. This device is an electrosurgical patient return electrode, not an algorithm or AI system. Its function is physical and electrical contact for current return during electrosurgery, not the standalone processing of data or images.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Engineering Design Specifications: Such as designing for a current density of less than 100 mA per square inch.
• Conformance to Industry Standards: Specifically, ANSI / AAMI HF 18-1993 for electrosurgical devices, with the exception of the minimum capacitance requirement.
• Predicate Device Equivalence: The primary assertion for clearance is that the device is substantially equivalent to a legally marketed predicate device (K972273), implying that the predicate device's established safety and effectiveness serve as the "ground truth" for the new device's performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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