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The DermaSensor device is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and above to assist in the decision regarding referral of the patient to a dermatologist. The DermaSensor device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used as the sole diagnostic criterion nor to confirm clinical diagnosis of skin cancer.

The DermaSensor device (hereinafter referred to as 'DermaSensor', or the 'DermaSensor device'; Figure 1) utilizes optical spectroscopy and an artificial intelligence/machine learning (AI/ML) based software algorithm to analyze an intact skin lesion to which the device is non-invasively applied. The device is a combination of a handheld unit and a base unit. The handheld unit contains a xenon arc lamp and a fiber-optic probe tip which together transmit broadband white light to a lesion surface. Samples of the backscattered light from the tissue are collected by an adjacent detection optical fiber, also within the probe tip, and are conveyed to a microspectrometer, vielding Elastic Scattering Spectroscopy (ESS) spectral recordings. The handheld unit is operated using a touchscreen interface with step-by-step guidance. The small fiber-optic tip is the only component that contacts the patient. The handheld unit remains in the base when not actively being applied to a lesion and its battery is recharged by the base's wireless charging mechanism. The base unit also contains calibration material that is accessible to the handheld unit. In the DermaSensor device, analysis of the optical recordings of backscattered light over the range of wavelengths is carried out using a proprietary ML-derived classifier algorithm. The spectrum of scattered intensity vs. wavelength is a pattern, which is analyzed by a proprietary classifier algorithm in the device's built-in microprocessor to assess for the potential presence of melanoma. squamous cell carcinoma, or basal cell carcinoma. An internal microprocessor and classifier algorithm analyze the recording and provide results to the user at the point of care, Results are provided as "Monitor," for a negative result, or "Investigate Further" for a positive result. For positive output ("Investigate Further") the DermaSensor additionally displays a Similarity Score of 1-10, with higher scores representing greater similarity to signals seen in malignant lesions.