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510(k) Data Aggregation
(26 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum Safe Temperature Rise (ANSI/AAMI HF-18, paragraph 4.2.3.1) | "The device is well within the requirements of the standard." (Tested with human volunteers and two electrosurgical generators, with and without a single linen layer between the pad and the patient). Infrared camera used to record temperature changes. |
| Electrode Contact Impedance (Minimum Capacitance Requirement) | "Conformance with the minimum capacitance requirement was demonstrated through bench testing. Device capacitance was evaluated under several different test setups intended to simulate clinical use." |
| Current Limiting (<100 mA/cm²) | "This device is designed to be current limiting (<100 mA/cm²) so as to prevent the patient from getting return electrode site burns. This current limiting attribute is achieved by selecting materials with high impedance per area." (This is a design characteristic, not explicitly a test result for the Dual Cord device, though implied by materials selection and overall safety claims). |
| Similar Technological Characteristics to Predicate Device | "The technological characteristics of the proposed device are similar to the predicate device. The only difference is the addition of a second cord... Other technological characteristics (capacitive coupling and pressure reduction) are identical to the predicate device." |
2. Sample Size for Test Set and Data Provenance
- Maximum Safe Temperature Rise: "human volunteers" were used. The exact number is not specified in the abstract, but the protocol document (X1150075-10 revision 3) would likely contain this detail.
- Electrode Contact Impedance: Bench testing was performed; no human subjects or patient data.
- Data Provenance: The testing was conducted by Megadyne Medical Products, Inc. in Draper, UT, USA. This suggests the data is from the USA. It is prospective testing designed to evaluate the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical accessory, and the "ground truth" is based on objective measurements against engineering and safety standards, not expert interpretation of clinical data in the same way an AI diagnostic tool would be. The "ground truth" is defined by the ANSI/AAMI HF-18 standard.
4. Adjudication Method for the Test Set
Not applicable. Testing involves direct measurement and comparison to an established engineering standard, not subjective interpretations requiring 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 is not an AI/ML device, nor is it a diagnostic device that involves human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical electrosurgical accessory. Its performance is evaluated through physical and electrical testing.
7. The Type of Ground Truth Used
The "ground truth" is defined by the ANSI/AAMI HF 18-2001, Electrosurgical Devices standard. This standard sets objective performance criteria for maximum safe temperature rise and minimum capacitance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The device's performance is tested directly against engineering standards.
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