Search Results

These specific EVAP electrodes can be used for vaporization, ablation, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.

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.

The provided text is a 510(k) summary for the Richard Wolf EVAP Electrodes, which are electrosurgical devices. It details the device's description, intended use, and claims of substantial equivalence to previously marketed devices. However, it does not contain specific acceptance criteria or a study proving that the device meets those criteria in the way a clinical performance study for an AI/ML device would.

Instead, the performance data section relies on compliance with a general safety standard and a canine model study for a related physiological effect, not for proving a specific diagnostic accuracy or classification performance.

Therefore, many of the requested points cannot be directly answered from the provided document as they pertain to clinical performance studies, particularly for AI/ML devices, which is not the nature of this submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The primary "acceptance criteria" here appear to relate to meeting appropriate sections of the ANSI/AAMI standard on High-Frequency Devices and demonstrating substantial equivalence to predicate devices.
• Reported Device Performance:
  • Safety Standard Compliance: "Devices were tested to meet the appropriate sections of the ANSI/AAMI standard on High Frequency Devices." (Implies compliance was achieved but no specific metrics are given for this compliance).
  • Canine Model Study: "coagulation depth increases with higher wattage, but does not exceed 2-3mm." "Irrigation reduces the risk of heat damage." (These are observations, not specific performance metrics against an acceptance criterion.)
  • Substantial Equivalence: Concluded to be equivalent to existing electrodes.

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: Not applicable in the context of human clinical trial test sets as described. For the canine model, the sample size is not specified.
• Data Provenance: The canine model study is mentioned, implying in vivo animal data. No mention of human clinical data or its provenance (country, retrospective/prospective).

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. The ground truth for the device's function (e.g., coagulation depth) was observed directly in the canine model, not established by expert review of images or cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No expert adjudication process is described.

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. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a surgical electrode, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the canine model study, the ground truth for coagulation depth and heat damage was likely direct measurement and observation during or after the in vivo animal experiment.

8. The sample size for the training set

• Not applicable. This is not a machine learning solution requiring a training set.

9. How the ground truth for the training set was established

• Not applicable.

Ask a specific question about this device