(63 days)
The MegaDyne uncoated electrode is indicated for use in any surgical procedure which requires electrosurgical cutting and/or coagulation.
The MegaDyne uncoated electrosurgical electrode is very similar to other, commercially available, stainless steel electrodes. It is used in various electrosurgical procedures, in conjunction with a hand- or foot-activated "pencil", which is connected to a standard electrosurgical unit (ESU). The device consists of a formed stainless steel rod, insulated over most of its length by polyolefin insulation. The flat, or blade, end of the electrode conducts energy from a standard high-frequency electrosurgical generator to the target tissue. The round end fits into a standard electrosurgical handpiece. Various electrode configurations, such as blade, needle, and ball ends are available in assorted lengths from 2.5" to 8" overall. The blade, needle, and ball configurations are all identical to currently available uncoated stainless steel electrodes on the U.S. market.
Please find the requested information regarding the acceptance criteria and study details below, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance with relevant clause of ANSI / AAMI HF18 - 1993: 4.3.5.4, Dielectric withstand of accessories. | The Electrosurgical Electrode conforms with the relevant clause of ANSI / AAMI HF18 -1993: 4.3.5.4, Dielectric withstand of accessories. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding a specific "test set" in the context of clinical or performance data for software or diagnostic devices. The device is an electrosurgical electrode, and the performance data cited is related to an electrical safety standard. Therefore, there's no mention of sample size, country of origin, or retrospective/prospective nature as would be typical for clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not explicitly mention the use of experts to establish ground truth for a test set. The performance data refers to a technical standard (ANSI / AAMI HF18 - 1993), which likely involves engineering or electrical testing rather than expert-derived ground truth.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method as it does not refer to a test set requiring such a process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document is for an electrosurgical electrode, a physical medical device, and does not involve AI or human-in-the-loop performance studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No. This is not applicable to the device described, as it is a physical electrosurgical electrode and not an algorithm or software.
7. Type of Ground Truth Used:
The "ground truth" in this context is the adherence to the Dielectric withstand of accessories as defined by the ANSI / AAMI HF18 - 1993 standard. This is a measure of the insulation's ability to withstand voltage without breaking down.
8. Sample Size for the Training Set:
The document does not mention a training set as it is not for a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set mentioned for this device.
§ 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.