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510(k) Data Aggregation
K Number
K992765Device Name
CYNOSURE DIODERMManufacturer
Date Cleared
1999-09-08
(22 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The DioDerm Laser is intended for use in dermatology for photocoagulation of vascular lesions.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for the Cynosure DioDerm Laser, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory information, labeling, and general responsibilities under the Act.
There is no mention of:
- Acceptance criteria or reported device performance in a table.
- Details of any study (sample size, data provenance, number or qualifications of experts, adjudication method).
- Any multi-reader multi-case (MRMC) comparative effectiveness study, effect size, or human-in-the-loop performance.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set size or how its ground truth was established.
Therefore, I cannot fulfill your request based on the provided input.
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