(274 days)
This device is designed to be used whenever monopolar electrosurgy 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. At the same time the product reduces the risk of pressure related injury due to immobility during surgery.
Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.
The Mega Soft Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric lavers of a viscoelastic polymer called Akton . (The top layer of polymer is thinner than the bottom layer.) The Akton polymer is encapsulated by a layer of urethane film. One or two two-conductor cables connects the conductive layer of the device to a two conductor DetachaCable". The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on top, on the side labeled "patient side".
The adult-size 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 1/2". The pediatricsize device is approximately 12" x 26" x 1/2" and is intended for pediatric patients weighing between 0.8 and 50 lbs.
This is a 510(k) summary for a medical device that received clearance, not a study report. Therefore, it primarily focuses on establishing substantial equivalence to existing devices rather than presenting the results of a detailed clinical efficacy or performance study with specific acceptance criteria and ground truth validation.
Based on the provided information, I can answer some of your questions but others are not applicable as this document is not a study report.
1. Table of Acceptance Criteria and Reported Device Performance
This document, a 510(k) summary, does not specify quantitative acceptance criteria for device performance in the way a clinical study would. It focuses on demonstrating substantial equivalence to predicate devices, primarily through adherence to recognized safety standards. The performance is implied to be equivalent to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of measurable performance metrics for a novel study. | Implied to be equivalent to predicate devices based on technological characteristics and safety testing to standards. |
| Conformance to ISO 60601-2-2:2006 (Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment) | Successful conformance testing (implied by statement: "Megadyne has conducted extensive testing to ensure conformance...") |
| Conformance to ANSI / AAMI HF 18-2001 (Electrosurgical Devices) | Successful conformance testing (implied by statement: "Megadyne has conducted extensive testing to ensure conformance...") |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical study assessing a new algorithm or diagnostic performance. The testing mentioned is safety and performance compliance to standards for the electrosurgical device itself. Therefore, sample size and data provenance in this context are not applicable in the way you might expect for an AI/algorithm study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, in the sense of expert consensus for diagnostic accuracy, is not relevant for this type of device submission. The device is an electrosurgical patient return electrode, and its evaluation focuses on electrical safety and performance, not diagnostic accuracy.
4. Adjudication method for the test set
This is not applicable for the reasons stated above.
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
This is not applicable. The device is an electrosurgical patient return electrode, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable. The "ground truth" for an electrosurgical return electrode is its ability to safely and effectively conduct electrosurgical energy and reduce the risk of pressure-related injury. This is assessed through engineering testing and adherence to recognized standards, not by expert consensus on clinical findings or pathological diagnoses.
8. The sample size for the training set
This is not applicable. There is no AI algorithm being developed or trained for this device.
9. How the ground truth for the training set was established
This is not applicable. There is no AI algorithm being developed or trained for this device.
Study Description (based on the provided 510(k) Summary):
The document describes a device safety and performance validation rather than a typical clinical study. The "study" (or validation process) performed by Megadyne Medical Products, Inc. for the Mega Soft Patient Return Electrode primarily focused on demonstrating:
- Technological Equivalence: The device shares the same technological characteristics as predicate devices.
- Safety and Effectiveness Equivalence: The safety and effectiveness questions are considered the same as for predicate devices, with no new technologies incorporated.
- Conformance to Standards: "Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices."
This type of submission relies on demonstrating that the new device meets established industry safety and performance standards equivalent to legally marketed predicate devices, rather than performing a de novo clinical trial with specific diagnostic accuracy metrics.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.