(231 days)
This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.
The Disposable Neutral Electrode, is an accessory for high voltage high frequency electrosurgical devices, connect it to the body of the PATIENT and the HF SURGICAL EQUIPMENT, it can perform it function for provide a return path for the HIGH FREQUENCY current and unwanted burns are avoided. Construction --- The product consists of Electrode carrier and Clarity PET. It is packed in an al film bag. The electrode is composed of conductive gel, aluminum foil, sponge, anti-sticking film and connecting wire. Conductive gel is composed of high molecular monomer, glycerinum and water, which is a gel, can be conducted in high frequency and has voltage-sensitive by polymerization.
The provided text describes a submission for a Disposable Neutral Electrode (Model: GP202) and its substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria with performance metrics.
Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment cannot be extracted from the provided text. This document is a 510(k) summary focused on demonstrating equivalence and compliance with general safety and performance standards.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided in the requested format. The document states that "Laboratory testing was conducted to validate and verify that the Disposable Electrosurgical Pencil met all design specifications, including electrical safety, EMC, biocompatibility, specification." (Section 5) and that "Electrical safety test, Mechanical performance test, and Biocompatibility test have been done to demonstrate the safety and performance of subject devices." (Section 7.0). However, it does not list specific numerical acceptance criteria (e.g., maximum impedance, minimum adhesion strength) or the quantitative performance results achieved by the device against those criteria. It only states that the tests demonstrated compliance and did not result in safety hazards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined from the text. The document does not specify sample sizes for any of the tests (electrical safety, mechanical performance, biocompatibility). It also does not mention data provenance (country of origin, retrospective/prospective). These tests appear to be laboratory-based rather than clinical data tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Cannot be determined. This device is a disposable neutral electrode, and the testing described (electrical safety, mechanical, biocompatibility) does not involve human interpretation or "ground truth" established by clinical experts in the way an imaging AI device would. The "ground truth" for these tests would be objective measurements against predefined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be determined. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement. The laboratory tests for this device would have objective pass/fail criteria based on standards.
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
- No. This is not an AI device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective standards and measurements. For the tests mentioned (electrical safety, mechanical performance, biocompatibility, EMC), the "ground truth" would be the established international and national standards (e.g., IEC60601-1, IEC 60601-2-2, ISO 10993-5, ISO 10993-10) and objective measurements verifying compliance with these standards.
8. The sample size for the training set
- Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
Summary of what the document DOES provide:
- Device Name: Disposable Neutral Electrode, Model GP202
- Intended Use: For adult patients with conductive adhesive gel, used as a neutral reference during electrosurgical procedures.
- Testing Conducted: Electrical safety test, Mechanical performance test, Biocompatibility test.
- Compliance Standards:
- "510(k) Guidance Document for General Surgical Electrosurgical Devices"
- ANSI/AAMI American National Standard for Electrosurgical Devices
- IEC60601-1 (International Standard for electrical medical device)
- IEC 60601-2-2 (International Standard for Electrosurgical Devices)
- ISO 10993-5 and ISO 10993-10 (Biocompatibility)
- Conclusion: The tests demonstrated compliance with requirements and did not reveal any safety hazards, leading to a conclusion of substantial equivalence to predicate devices and that the device is safe and effective.
§ 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.