(170 days)
For use in laparoscopic minimally invasive surgical procedures to provide monopolar electrocautery capability to dissect and coagulate tissue.
The Family of Micro Electrode Instruments are intended for use in laparoscopic minimally invasive surgical procedures to provide monopolar electrocautery capability to dissect and coagulate tissue.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dielectric Insulation Test @ 3000V | Passed (100% sampling plan indicated successful testing) |
| Sterility Assurance Level (SAL) of $10^{-6}$ | Achieved after cleaning and sterilization (intended reuse) |
| Substantial Equivalence to Predicate Device | Deemed comparable in safety and effectiveness |
Study Information
Please note that this document is a summary of safety and effectiveness and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical trial report or a performance study with the metrics typically associated with AI/software device evaluations. Therefore, many of the requested fields below are not applicable or cannot be determined from the provided text.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the Dielectric Insulation Test, it states a "100% sampling plan." This implies all manufactured units (or a significant representative batch) were tested, but the exact number isn't specified.
- Data Provenance: Not applicable. The "test set" here refers to physical devices undergoing bench testing, not a dataset of medical images or patient records. The document is from the USA.
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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, in the context of this document, is established by adherence to engineering specifications and performance standards (e.g., dielectric breakdown at a certain voltage), not by expert consensus on medical findings.
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Adjudication method for the test set:
- Not applicable. The tests described are objective engineering measurements.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument, not an AI-powered diagnostic tool, so such a study would not be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (surgical instrument), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the acceptance criteria consists of established engineering standards (e.g., dielectric strength) and the demonstrated performance of the predicate device. For sterility, it's a measurable SAL.
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The sample size for the training set:
- Not applicable. This device does not use an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This device does not use an AI algorithm.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).