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The DermaScan C is an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.

The DermaScan C provides the following visualization modes: a. 2-dimensional B-scan, displayed in real time b. M-scan, displayed in real time c. A-scan, as a "frozen" image derived from a B-scan line.

The Cortex DermaScan C Ultrasonic System did not undergo a clinical study to prove it meets acceptance criteria for this 510(k) submission.

The document states:

• Acceptance Criteria & Device Performance: Not provided, as clinical tests were deemed not required.
• Sample size for the test set and data provenance: No test set was used for clinical performance evaluation.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no test set was used.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted.
• Standalone (algorithm only) performance: Not applicable, as this is an ultrasound system, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Reasoning for lack of clinical studies:
The application states, "Since the DermaScan C is identical to a previously-cleared device, clinical tests are not required." (Page A 4, Section 6b). The predicate device is identified as the "DermaScan C Ultrasonic 3D skin scanner, K894834".

The submission focuses on non-clinical tests:

• Software revalidation.
• Ultrasonic emission tests by an outside laboratory.
• Electrical safety tests.

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