(22 days)
ERBE Disposable Patient Return Electrodes are Indicated for Use only in conjunction with Electrosurgical Generators for cutting and coagulation of human tissue. The Electrodes are for use with Generators with Return Electrode Safety Systems (divided contact surface) and Generators without Return Electrode Safety Systems (single contact surface).
The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used orimarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers. The Erbe electrodes and are to be sold with and without a pre-attached cable.
The provided text is a 510(k) summary for the ERBE Disposable Patient Return Electrode. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance studies with specific acceptance criteria and detailed methodology for a new, complex AI/CAD device.
Based on the provided text, the following information can be extracted, and significant limitations exist due to the nature of a 510(k) for a relatively straightforward medical device like a disposable patient return electrode in 1997.
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or detailed performance metrics are provided in the document. The general acceptance criterion is "Safe and Effective for their intended purpose when used in accordance with the Instructions for Use," and achieving "substantial equivalence" to predicate devices. The performance is summarized qualitatively.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safe and Effective for intended purpose (cutting and coagulation of human tissue with electrosurgical generators) | "The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers." "Disposable return electrodes have been manufactured and distributed worldwide by Leonhard Lang GmbH and the ERBE Disposable Return Electrodes utilize the same materials and technology. There are no known adverse reactions or field problems with electrodes utilizing this technology or materials." |
| Substantial Equivalence to predicate devices | Found by FDA to be "substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." |
| Compatibility with Electrosurgical Generators | "The Erbe electrodes and are to be sold with and without a pre-attached cable...compatible with generators from other manufacturers." "The Electrodes are for use with Generators with Return Electrode Safety Systems (divided contact surface) and Generators without Return Electrode Safety Systems (single contact surface)." |
| No known adverse reactions or field problems | "There are no known adverse reactions or field problems with electrodes utilizing this technology or materials." (Referring to the materials and technology used in predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this 510(k). This document does not describe a clinical performance study with a test set of data. The claim of safety and effectiveness is based on the use of "the same materials and technology" as predicate devices with "no known adverse reactions or field problems" from those predicate devices. This indicates reliance on historical data and material equivalence rather than a new clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There is no mention of experts establishing ground truth for a test set, as this is not a study involving diagnostic interpretation or complex algorithms.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
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 is not an AI or CAD system, so an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive accessory and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth," in a broad sense for this type of device, is established by historical clinical performance and safety records of analogous predicate devices and the physical/electrical properties of the materials used. The statement "There are no known adverse reactions or field problems with electrodes utilizing this technology or materials" serves as the primary basis for safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set for machine learning.
§ 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.