(82 days)
The Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
The Monopolar and Bipolar Cautery Cords have been designed as an accessory to electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments include scissors, forceps, and dissectors. The cord connects to the electrosurgical generator on one end and the active instrument on the other end. The Monopolar and Bipolar Cautery Cords are insulated cords with an instrument-mating connector on one end and generatormating connector on the other end.
This is an electrosurgical cord, not an AI device. Therefore, the questions related to AI/algorithm performance, training sets, and expert adjudication are not applicable. The provided text describes a traditional medical device (Monopolar and Bipolar Cautery Cord) for which the acceptance criteria and performance evaluation are based on engineering and safety standards rather than diagnostic accuracy determined by AI.
Here's the relevant information based on the provided text for a traditional medical device:
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance | Study Type |
|---|---|---|
| Material Equivalence | Substantially equivalent to predicate device in terms of design, materials, technological characteristics. | Comparative Analysis |
| Functional Verification | Meets design input requirements and demonstrates substantial equivalence to predicate. | Performance Testing (Functional, Mechanical, Electrical Safety, Simulated Procedures) |
| Dimensional Measurements | Conducted | Performance Testing |
| Mechanical Performance | Conducted | Performance Testing |
| Electrical Safety | Conducted | Performance Testing |
| Use in Simulated Surgical Procedures | Conducted | Performance Testing |
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Sample size used for the test set and the data provenance: Not applicable. This device is an accessory to an electrosurgical unit, and the performance testing described is engineering-based (dimensional, mechanical, electrical safety, simulated use), not based on a "test set" of patient data or clinical images.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI devices (e.g., diagnosis, segmentation) is not relevant for this electrosurgical cord. Performance was evaluated against engineering specifications and predicate device equivalence.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic studies, which is not relevant here.
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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 is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and functional equivalence to a legally marketed predicate device. This is determined through objective measurements and tests rather than clinical diagnoses or outcomes data.
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The sample size for the training set: Not applicable. This is not an AI device.
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How the ground truth for the training set was established: Not applicable. This is not an AI 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.