(406 days)
used for The EVAP roller electrodes can be be removing/vaporization/ablation of soft tissue. For example; on the prostate or on myomas. The electrodes may also be used for coagulation.
The EVAP electrode is an electrosurgical device made of medical grade stainless steel, teflon, new silver and Hytrel tubing. Some EVAP versions have gold plated rollers.
This 510(k) summary describes a traditional medical device (electrosurgical electrode) and not an AI/ML-based device. Therefore, the questions related to acceptance criteria, study design for AI models, ground truth, expert adjudication, and MRMC studies are not applicable in this context.
However, I can extract the performance data and intended use as described for this device:
1. A table of (not applicable "acceptance criteria" but "performance data") and the reported device performance:
| Category | Description |
|---|---|
| Device Tested | Electrosurgical Vaporization (EVAP) electrode |
| Standards Met | Appropriate sections of the ANSI/AAMI standard on High Frequency Devices |
| Clinical Tests | Canine Models: Coagulation depth increases with higher wattage but does not exceed 2-3mm. Irrigation reduces the risk of heat damage. |
| Limitations | Long term morbidity and healing were not known from the clinical tests. |
| Intended Use | Removing/vaporization/ablation of soft tissue (e.g., prostate, myomas), also for coagulation. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The clinical tests were performed "Using Canine Models," implying a veterinary test setting rather than human data.
- Data Provenance: Canine Models (animal study), retrospective or prospective not specified but typically clinical tests are prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a traditional medical device, and "ground truth" in the AI/ML sense (e.g., for image interpretation) is not relevant here. The clinical tests involved observing coagulation depth in canine models.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as this refers to adjudication of expert labels for AI/ML ground truth.
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:
- Not applicable, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical electrosurgical electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the canine model, the "ground truth" would be the direct measurement of coagulation depth within the tissue, likely obtained through histological examination or direct observation during the procedure. This is analogous to a pathology/direct measurement ground truth.
8. The sample size for the training set:
- Not applicable for a physical device, as there is no "training set" in the AI/ML context.
9. How the ground truth for the training set was established:
- Not applicable for a physical device.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).