(46 days)
The UM-D30 Coagulator is used in small surgical procedures in dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.
Coagulator Device Name: UM-D30
The provided text is a 510(k) premarket notification letter from the FDA regarding the UM-D30 Coagulator. It confirms the device's substantial equivalence to previously marketed devices for specific indications of use. This document is a regulatory approval letter and does not contain the acceptance criteria or study details for device performance.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Results of a standalone algorithm performance study.
- The type of ground truth used.
- The sample size for a training set.
- How ground truth for a training set was established.
The document primarily focuses on the regulatory clearance for the device based on its substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
§ 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.