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510(k) Data Aggregation
(345 days)
The Cry-Ac Tracker Cam is a device that measures the temperature of the skin when attached to a cryogen delivery system to the selected skin lesion using the latest infrared censoring technology.
The Cry-Ac Tracker Cam is a device that measures the temperature of the skin when attached to a cryogen delivery system to the selected skin lesion using the latest infrared censoring technology.
This document is an FDA 510(k) clearance letter for the Brymill Cryogenic Systems Cry-Ac Tracker Cam. It primarily concerns the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
Critical missing information for your request:
The document does not contain any information about the acceptance criteria, device performance, results of a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training/test set details.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about the study, as this information is not present in the provided text.
This type of FDA letter confirms clearance based on the manufacturer's submission demonstrating substantial equivalence, but it does not typically include the detailed study methodology or results within the letter itself. Those details would be part of the original 510(k) submission document, which is not provided here.
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(110 days)
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