Table 1.
Characteristics of Test Lesions and Corresponding Device Classifications (N = 50).
| Anatomic location, n (%) | |||
|---|---|---|---|
| Trunk | 15 (30) | ||
| Upper extremity | 14 (28) | ||
| Lower extremity | 11 (22) | ||
| Head | 10 (20) | ||
| Surface, n (%) | |||
| Elevated | 27 (54) | ||
| Flat | 23 (46) | ||
| Texture, n (%) | |||
| Smooth | 25 (50) | ||
| Rough | 25 (50) | ||
| Color, n (%) | |||
| Light | 27 (54) | ||
| Dark | 17 (34) | ||
| Light and dark | 6 (12) | ||
| Pigmentation a , n (%) | |||
| Pigmented | 21 (42) | ||
| Non-pigmented | 29 (58) | ||
| Melanocytic b , n (%) | |||
| Yes | 13 (26) | ||
| No | 37 (74) | ||
| Biopsied, n (%) | |||
| Yes | 38 (76) | ||
| No | 12 (24) | ||
| Final histopathologic read c , n (%) | |||
| Actinic keratosis | 3 (6) | ||
| Basal cell carcinoma | 9 (18) | ||
| Benign melanocytic nevus | 3 (6) | ||
| Benign other | 4 (8) | ||
| Blue nevus | 1 (2) | ||
| Lentigo | 2 (4) | ||
| Melanoma | 4 (8) | ||
| Mildly atypical melanocytic nevus | 2 (4) | ||
| Seborrheic keratosis | 10 (20) | ||
| Severely atypical melanocytic nevus | 3 (6) | ||
| Squamous cell carcinoma | 9 (18) | ||
| Fitzpatrick skin type of patients d , N (%) | |||
| I. Always burns, never tans | 5/44 (11.4) | ||
| II. Always burns, tans minimally | 28/44 (63.6) | ||
| III. Sometimes mild burn, tans uniformly | 8/44 (18.2) | ||
| IV. Burns minimally, always tans well | 2/44 (4.5) | ||
| V. Very rarely burns, tans very easily | 1/44 (2.3) | ||
| Device classification | Total | Device + | Sensitivity (%) |
| Overall Sensitivity | 25 | 24 | 96.0 |
| Melanoma | 4 | 4 | 100.0 |
| Severely atypical melanocytic nevus | 3 | 3 | 100.0 |
| Basal cell carcinoma | 9 | 9 | 100.0 |
| Squamous cell carcinoma | 9 | 8 | 88.9 |
| Total | Device− | Specificity (%) | |
| Overall Specificity | 25 | 9 | 36.0 |
| Seborrheic keratosis | 10 | 4 | 40.0 |
| Mildly atypical melanocytic nevus | 2 | 0 | 0.0 |
| Lentigo | 2 | 2 | 100.0 |
| Blue Nevus | 1 | 0 | 0.0 |
| Benign Other | 4 | 0 | 0.0 |
| Benign Melanocytic nevus | 3 | 1 | 33.3 |
| Actinic keratosis | 3 | 2 | 66.7 |
Pigmentation of lesion was determined by an internal dermatologist reviewing the images of the lesion cases and assessing whether or not the lesion was or was not pigmented.
Determination of if a lesion was melanocytic was performed by an internal dermatologist classifying the different parent pathology classifications into buckets of melanocytic or non-melanocytic.
Basal cell carcinoma, squamous cell carcinoma, melanoma, and severely atypical melanocytic nevus lesions were considered malignant and all others benign. Severely dysplastic melanocytic nevi were considered malignant because they are often managed with re-excision by dermatologists.
50 lesions utilized in the study were procured from 44 patients.