(72 days)
CONMED® Macrolyte® Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Macrolyte® Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.
The CONMED® Macrolyte® Dispersive Electrode is a single use, non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The CONMED® Macrolyte® Dispersive Electrode is to be used on any patient where full skin contact and a suitable placement site can be obtained. Use of this product for unintended applications could lead to an unsafe condition. The surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolated the conductive area from surgical fluids. There are 9 models of the CONMED® Macrolyte® Dispersive Electrode.
The provided document is a 510(k) summary for a medical device called the CONMED® Macrolyte® Dispersive Electrode. It describes the device, its intended use, and general safety and performance information.
However, it does not contain any information regarding clinical studies, AI performance, or human reader effectiveness studies. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics, biocompatibility testing (material selection and in vitro tests), and adherence to general safety standards (IEC 60601-2-2).
Therefore, I cannot provide answers to many of your questions as the information is not present in the given text.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics of the device as it would for, say, an AI algorithm's accuracy. Instead, it refers to conformance with established standards for medical electrical equipment and biocompatibility.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance (Implied) |
|---|---|
| IEC 60601-2-2:2009 Edition 5.0 (Medical Electrical Equipment) | Conforms to requirements |
| ISO 10993-5: 1999 (Tests for cytotoxicity, in vitro methods) | Conforms to requirements |
| ISO 10993-10: 2002/Amd 1:2006 (Tests for Irritation and delayed-type hypersensitivity) | Conforms to requirements |
| Biocompatibility of selected components based on ISO 10993-1 | Materials selected demonstrate appropriate levels of biocompatibility |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. The listed performance testing refers to in vitro biocompatibility tests and adherence to engineering standards, not clinical performance or algorithmic evaluation.
- Data Provenance: Not applicable/Not provided.
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)
- Number of Experts: Not applicable/Not provided. The ground truth for biocompatibility is established by adherence to ISO standards and in vitro test results, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not provided.
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
- MRMC Study: No. This document is for a dispersive electrode, an electrosurgical accessory, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For biocompatibility, the ground truth is established by the results of in vitro cytotoxicity, irritation, and hypersensitivity tests as per ISO 10993 standards. For electrical safety, the ground truth is adherence to IEC 60601-2-2.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not provided. There is no AI training set for this device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/Not provided. There is no AI training set 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.