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The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.

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This document is a 510(k) premarket notification acceptance letter for the device "Oligio X". It does not describe acceptance criteria for device performance, nor does it present a study proving the device meets performance criteria.

It confirms that the "Oligio X" device is substantially equivalent to a previously cleared predicate device ("Oligio" K221989) and outlines the regulatory requirements the device must meet.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone algorithm-only performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The central point of this document is the FDA's determination of substantial equivalence, which is based on the device having the "same electrification, principle, method, indication for use, and same components" as the predicate device, with differences limited to the color of the main body, handpiece, handpiece tip, and the GUI (Graphical User Interface) of the device.

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