(126 days)
CONMED® Surefit™ Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REM™, ARM™, and NESSY, ™etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The Surefit™ Dual 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® Surefit™ Dual 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® Surefit™ Dual 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.
The provided text is a 510(k) summary for a medical device called the CONMED® Surefit™ Dual Dispersive Electrode. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance results in the context of an AI/ML model for diagnostic or predictive purposes.
Therefore, the specific information requested in the prompt regarding acceptance criteria, studies, sample sizes, expert involvement, and ground truth for an AI/ML model is not present in this document.
However, I can extract the information related to the device's assessment methods:
Acceptance Criteria and Device Performance:
Since this is a submission for a dispersive electrode, the "acceptance criteria" discussed are related to meeting established standards for electrosurgical accessories, rather than performance metrics like sensitivity or specificity for an AI model.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance (Implied) |
|---|---|
| IEC 60601-2-2:2009 Edition 5.0 (Medical Electrical Equipment) | The device's performance conforms to the requirements of this standard. |
| ISO 10993-5: 1999 (Biological Evaluation - Cytotoxicity) | Biological safety of selected components assured through material selection and conformance to this standard. |
| ISO 10993-10: 2002/Amd 1:2006 (Biological Evaluation - Irritation & Hypersensitivity) | Biological safety of selected components assured through material selection and conformance to this standard. |
Explanation of Missing Information:
- Sample sized used for the test set and the data provenance: Not applicable. The document describes compliance with standards, not a test set for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML diagnostic or predictive device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of an AI/ML model. The "ground truth" here is the adherence to established engineering and biocompatibility standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Key takeaway: This document is a regulatory submission for a medical device that relies on established engineering and biocompatibility standards for its safety and effectiveness, not on an AI/ML model that would have the types of studies described in the prompt. The "acceptance criteria" are therefore compliance with these standards.
§ 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.