Output and Results
Output and Results
The DermaSensor device captures spectra that are generated from the reflectance of photons of light by different cellular and subcellular features (eg., nucleus size, condensed chromatin). The DermaSensor device records spectra samples of skin lesions and uses a proprietary algorithm that has been developed and validated through clinical studies on thousands of diagnosed lesions to classify an investigated lesion’s spectral properties against those of known malignant and benign lesions. The device provides an output of “Investigate Further” or “Monitor”, for each assessed lesion and assigns a unique Device Record Number (DRN), which appears with the result of the assessment on the Handheld Unit display.
| Output | Results |
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“Investigate Further” The Handheld Unit will display “Investigate Further” for lesions found to contain recorded properties associated with malignant lesions, such as melanoma, squamous cell carcinoma, and basal cell carcinoma. Spectral Score For lesions with an “Investigate Further” result, the Handheld Unit will display a score from 1 through 10 to indicate the degree of similarity the lesion's spectral recordings are to malignant lesions in studies (the "spectral similarity", e.g., 1 indicating the least similar to malignant lesions and 10 indicating the most similar to malignant lesions). A pivotal clinical trial showed that higher scores had greater positive predictive value for malignancy. However, low scores are still classified as "Investigate further" and should be considered as positive output when the device is used in referral decisions in addition to clinically relevant information.
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“Monitor” The Handheld Unit will display “Monitor” for lesions found to contain recorded properties associated with benign lesions. No Spectral Score is shown when the result is “Monitor”. |
You can find the most current information and literature on the DermaSensor device performance at DermaSensor.com.
IFU 40-0001 v7