(344 days)
QZS
Not Found
Yes
The device description explicitly states that the device utilizes "artificial intelligence/machine learning (AI/ML) based software algorithm" and a "proprietary ML-derived classifier algorithm".
No
Explanation: This device is for evaluating skin lesions to assist in referral decisions for suspected melanoma, basal cell carcinoma, or squamous cell carcinoma, not for treating these conditions.
Yes
The device is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma to assist in the decision regarding referral to a dermatologist, and its output is designed to help determine if a lesion should be "Monitor[ed]" or "Investigate[d] Further." This falls under the definition of diagnosis, as it aids in the identification of a disease or condition.
No
The device description clearly states it is a combination of a handheld unit and a base unit, which are hardware components. The software algorithm analyzes data collected by the hardware.
Based on the provided information, the DermaSensor device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- DermaSensor's Method: The DermaSensor device utilizes optical spectroscopy and applies a non-invasive probe directly to the intact skin lesion. It analyzes the backscattered light from the tissue in situ (on the living body). It does not take a sample from the body to be tested externally.
Therefore, because the DermaSensor device performs its analysis directly on the patient's skin lesion without taking a sample for external testing, it falls outside the definition of an In Vitro Diagnostic. It is a non-invasive diagnostic device.
Yes
The letter explicitly states "Control Plan Authorized (PCCP): Yes", indicating that the FDA has authorized the PCCP for this device.
Intended Use / Indications for Use
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.
Product codes
QZS
Device Description
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, yielding 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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.
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.
Input Imaging Modality
Optical spectroscopy, Elastic Scattering Spectroscopy (ESS) spectral recordings.
Anatomical Site
Skin lesions on primary lesions only. Exclusions: lesions that are previously biopsied, recurrent, or metastatic; on scars, tattoos, sunburned skin, or within a hairy area; or which are located on palms, soles, mucosal surfaces, genitals, ears, within 1 cm of the eye, or under nails.
Indicated Patient Age Range
40 and above.
Intended User / Care Setting
Physicians who are not dermatologists (e.g., primary care physicians). Primary care offices.
Description of the training set, sample size, data source, and annotation protocol
The training dataset contained 950 lesions contributing ~4,200 spectra while the testing dataset included 361 lesions, for a total of 1,311 skin lesions. The training and testing datasets were independent and were chosen randomly. This study dataset was later used entirely for algorithm training.
The algorithm was trained in the spectral range of 360 to 810 nm, selected due to the low signal-to-noise ratio in this range. Forty-seven wavelengths were chosen within this range to reduce dimensionality.
Patient demographics for training dataset (n=1067):
Age: 20-39 (81, 7.6%), 40-59 (87, 8.2%), 60-79 (604, 56.6%), 80+ (45, 4.2%), Unknown (250, 23.4%).
Fitzpatrick Phototype: I (67, 6.3%), II (332, 31.1%), III (244, 22.9%), IV (46, 4.3%), V (8, 0.7%), VI (3, 0.3%), Unknown (367, 34.4%).
Ethnicity/Race: White (784, 73.5%), Black or African American (5, 0.5%), Asian (9, 0.8%), Multiracial (2, 0.2%), Native Hawaiian or Other Pacific Islander (17, 1.6%), Unknown (250, 23.4%).
Gender: Male (424, 39.7%), Female (265, 24.8%), Unknown (378, 35.4%).
Anatomical locations for training dataset (n=2295):
Sun-exposed: Head/neck (136, 5.9%), Chest/Upper back (75, 3.3%), Forearms/hands (80, 3.5%), Lower legs (33, 1.4%), Other (25, 1.1%).
Unexposed: Buttocks/hips (2, 0.1%), Upper legs (25, 1.1%), Lower trunk (16, 0.7%), Other (1, 0.0%).
Unknown (1900, 82.9%).
Diagnosis for training dataset (n=2295):
Melanoma and severely dysplastic nevi (187, 8.2%), SCC (207, 9.0%), BCC (294, 12.8%), Mixed Malignant (2, 0.1%).
Melanoma mimic: SK (brown) (158, 6.9%), Benign Nevi (631, 27.5%), Spitz Nevi (0, 0.0%), Lentigo (98, 4.3%), Angioma (15, 0.7%), Dermatofibroma (4, 0.2%), Tattoo/foreign objects (0, 0.0%).
SCC Mimics: AK (172, 7.5%), Wart (14, 0.6%), Dermatitis (0, 0.0%), SK (nonbrown) (75, 3.3%).
BCC Mimics: Acne/rosacea (0, 0.0%), Sebaceous hyperplasia/cyst (3, 0.1%), Other benign tumors (0, 0.0%), Insect bite (0, 0.0%), Xanthoma/ xanthelasma (0, 0.0%).
Other malignant lesions (6, 0.3%), Other benign lesions (427, 18.6%).
Annotation protocol: Not Found.
Description of the test set, sample size, data source, and annotation protocol
The training dataset contained 950 lesions contributing ~4,200 spectra while the testing dataset included 361 lesions, for a total of 1,311 skin lesions. The training and testing datasets were independent and were chosen randomly. This study dataset was later used entirely for algorithm training.
Patient demographics for tuning dataset (n=438):
Age: 20-39 (62, 14.2%), 40-59 (87, 19.9%), 60-79 (216, 49.3%), 80+ (73, 16.7%).
Fitzpatrick Phototype: I (64, 14.6%), II (160, 36.5%), III (91, 20.8%), IV (50, 11.4%), V (54, 12.3%), VI (16, 3.7%), Unknown (3, 0.7%).
Ethnicity/Race: White (402, 91.8%), Black or African American (15, 3.4%), Asian (5, 1.1%), Multiracial (1, 0.2%), Native Hawaiian or Other Pacific Islander (15, 3.4%).
Gender: Male (169, 38.6%), Female (195, 44.5%), Unknown (74, 16.9%).
Anatomical locations for tuning dataset (n=1230):
Sun-exposed: Head/neck (192, 15.6%), Chest/Upper back (140, 11.4%), Forearms/hands (120, 9.7%), Lower legs (44, 3.6%), Other (41, 3.3%).
Unexposed: Buttocks/hips (5, 0.4%), Upper legs (40, 3.2%), Lower trunk (39, 3.2%), Other (2, 0.2%).
Unknown (610, 49.5%).
Diagnosis for tuning dataset (n=1230):
Melanoma and severely dysplastic nevi (38, 3.1%), SCC (83, 6.7%), BCC (107, 8.7%), Mixed Malignant (1, 0.1%).
Melanoma mimic: SK (brown) (209, 17.0%), Benign Nevi (367, 29.8%), Spitz Nevi (0, 0.0%), Lentigo (41, 3.3%), Angioma (12, 1.0%), Dermatofibroma (9, 0.7%), Tattoo/foreign objects (0, 0.0%).
SCC Mimics: AK (145, 11.8%), Wart (4, 0.3%), Dermatitis (0, 0.0%), SK (nonbrown) (104, 8.4%).
BCC Mimics: Acne/rosacea (0, 0.0%), Sebaceous hyperplasia/cyst (4, 0.3%), Other benign tumors (0, 0.0%), Insect bite (0, 0.0%), Xanthoma/ xanthelasma (0, 0.0%).
Other malignant lesions (1, 0.1%), Other benign lesions (109, 8.8%).
Annotation protocol: Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Standalone Algorithm Performance Evaluation (DERM-SUCCESS pivotal clinical study)
- Study type: International, multicenter, prospective, blinded clinical study.
- Sample size: 1,005 participants with 1,579 lesions from 22 study sites.
- Ground Truth: All enrolled lesions were biopsied. DermaSensor device output (binary classification of a negative result, "Monitor," or a positive result, "Investigate Further") was compared to pathology findings that were validated by two to five central study dermatopathologists depending on the histological severity and discordance for the diagnoses.
- Key Results:
- Overall sensitivity: 95.5% (91.7%-97.6%) for identification of melanoma, SCC, or BCC.
- Specificity for all high-risk lesions: 20.7% (18.5%-23.1%).
- Device sensitivity (95.5%) was superior to PCP sensitivity (83.0%, p-value 1 (95.5% + 20.7% = 116.2%).
- AUC: The area under the receiver operating characteristic (ROC) curve (AUROC) for the device was 0.7896. This was greater than the AUROC for PCPs, which was 0.7404 for all lesions. Device AUROC was also greater than the AUROC for the PCPs when limited to study lesions for which they reported low confidence in their clinical diagnosis, which was 0.5555.
DERM-SUCCESS initial reader study: "A Multi-Reader, Multi-Case (MRMC) Companion Study to the DERM-SUCCESS Clinical Study"
- Study type: MRMC study.
- Sample size: 108 readers (trained in internal medicine or family practice) evaluated 25 malignant (20% melanoma, 40% SCC, 40% BCC) and 25 benign lesions.
- Key Results:
- Device-aided PCPs had a higher sensitivity of 91.4% (95% CI: 85.7-97.1%) compared with unaided PCP sensitivity 82.0% (95% CI: 76.4-87.6%; p=0.0027).
- Sensitivity + specificity of PCPs aided by the device was greater than 1 (Odds Ratio 6.8, CI: 4.7 to 9.8, p
N/A
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DE NOVO CLASSIFICATION REQUEST FOR DERMASENSOR
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer. A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis.
NEW REGULATION NUMBER: 21 CFR 878.1830
CLASSIFICATION: Class II
PRODUCT CODE: QZS
BACKGROUND
DEVICE NAME: DermaSensor
SUBMISSION NUMBER: DEN230008
DATE DE NOVO RECEIVED: February 2, 2023
SPONSOR INFORMATION: DermaSensor, Inc. 80 SW 8th Street #2000 Miami, Florida 33130 USA
INDICATIONS FOR USE
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.
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LIMITATIONS
The performance of the device has not been specifically evaluated in patients with increased risk for skin cancer, e.g., inherited or drug-induced photosensitivity; genetic predisposition to melanoma or basal cell carcinoma (BCC): immune compromise: or other medical conditions that increase the risk of skin cancer or its metastasis.
The device is intended to assist in clinical decisions related only to the skin malignancies melanoma (including severely atypical nevi), squamous cell carcinoma (SCC), and BCC. It has been tested on each of these three common skin cancer types but has not been tested on rare skin cancer types; thus, it should not be used for lesions that are suggestive of malignancies other than melanoma, BCC and/or SCC.
The device is intended for use on primary lesions only and has not been tested on lesions that are previously biopsied, recurrent, or metastatic; on scars, tattoos, sunburned skin, or within a hairy area; or which are located on palms, soles, mucosal surfaces, genitals, ears, within 1 cm of the eye, or under nails.
Consistent with the lower prevalence of skin cancer in Fitzpatrick skin phototypes IV-VI. less data is available for sensitivity of the DermaSensor device for melanoma in these patients. The decision to refer patients with suspicious pigmented lesions in this group should be primarily based on clinical concern.
The sale, distribution, and use of the DermaSensor are restricted to prescription use in accordance with 21 CFR 801.109.
The device is not intended to be used as a stand-alone diagnostic device.
The device is not intended to replace biopsy.
The device is not intended to replace clinical decision making.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS.
DEVICE DESCRIPTION
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.
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Figure 1: DermaSensor Device
Image /page/2/Picture/1 description: This image shows a black electronic device and its base. The device is sleek and modern, with a glossy finish. The base is cylindrical and has a similar glossy finish. The device appears to be designed to fit into the base, possibly for charging or storage.
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.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
DermaSensor does not contain substances that are intended to be introduced into the human body nor absorbed by or locally dispersed in the human body. The patient contacting materials are comprised of a stainless-steel tip encapsulating silica core fiber optics and synthetic polymer. The device tip is a surface-contacting device intended to contact intact skin for less than 3 minutes, and the user remains gloved during operation; therefore, meeting the requirements of 15mm in diameter -
- -Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)
- Lesion on area of crust, psoriasis, eczema, or similar skin condition 」
- Lesion has erosion and/or ulceration with no area >2.5mm intact -
- -Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)
- -Lesion in which the device tip cannot be placed entirely within the border of the targeted area
- Lesion located on acral skin (e.g. sole or palms) -
- Lesion located within 1 cm of the eye -
- -Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention
- . Lesion located on mucosal surfaces (e.g. genitals, lips)
- -Lesion located on acute sunburn
- Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or ! squamous cell carcinoma requiring biopsy to assess risk of malignancy
See Table 7 and Figure 2, for additional summary information regarding the number of participants and inclusion/exclusion of participants in this study.
Table 7: Participant accountability
| | Participants
n (%) | Lesions
n (%) |
|-------------------------------|-----------------------|------------------|
| Enrolled | 1,021 | 1,598 |
| ITT Safety Population | 1,013 (99.2%) | 1,591 (99.6%) |
| Excluded from ITT Population | 8 (0.8%) | 7 (0.4%) |
| mITT Effectiveness Population | 1,005 (98.4%) | 1,579 (98.8%) |
| Excluded from mITT Population | 8 (0.8%) | 12 (0.8%) |
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Image /page/13/Figure/0 description: This image shows a flow diagram of a clinical trial. The trial started with 22 sites, 18 in the US and 4 in Australia. 1,028 subjects with 1,598 lesions were recruited, and then 1,021 subjects with 1,598 lesions were enrolled. The diagram also shows the number of subjects and lesions that were excluded from the trial at each stage, as well as the reasons for exclusion.
Figure 2: Inclusion/Exclusion diagram for all recruited participants and lesions
Table 8 summarizes the demographics of participants in the study. The participants in the DERM-SUCCESS pivotal study included a majority of older patients (age 60-79), Fitzpatrick phototype I-III, and individuals who self-identified as White. This pattern reflects the greater incidence of skin cancer in these populations, particularly considering that lesions on the palms, soles, and under the nails were specifically excluded from the study.
Table 8: Participant characteristics in DERM-SUCCESS pivotal study (mITT, n=1,005)
| Characteristics | n (%) |
|---|---|
| Sex | |
| Male | 487 (48.5%) |
| Female | 518 (51.5%) |
| Age | |
| Mean (STD) | 58.5 (15.1) |
| Median (Q1-Q3) | 60.0 (49.0-69.0) |
| Min-Max | 22-95 |
| Ethnicity | |
| Hispanic or Latino | 79 (7.9%) |
| Not Hispanic or Latino | 913 (90.8%) |
| Unknown | 13 (1.3%) |
| Race | |
| White | 976 (97.1%) |
| Native Hawaiian or Other Pacific Islander | 3 (0.3%) |
| Asian | 9 (0.9%) |
| Black or African American | 7 (0.7%) |
| Other/Multiracial | 10 (1.0%) |
| Fitzpatrick Phototype | |
| I - Always burns, never tans | 99 (9.9%) |
| II - Always burns, tans minimally | 278 (27.7%) |
| III - Sometimes mild burn, tans uniformly | 352 (35.0%) |
| IV - Burns minimally, always tans well | 148 (14.7%) |
| V - Very rarely burns, tans very easily | 110 (10.9%) |
| VI - Never burns | 18 (1.8%) |
| Risk Factors | |
| Ultraviolet light exposure (natural or tanning bed) | 455 (45.3%) |
| Weakened immune system | 32 (3.2%) |
| Family history of skin cancer | 332 (33.0%) |
| Xeroderma Pigmentosum | 1 (0.1%) |
| Fair skin; freckling; light hair | 362 (36.0%) |
| Many moles and/or dysplastic nevi | 331 (32.9%) |
| Personal history of skin cancer | 233 (23.2%) |
| New or changing lesion(s) | 725 (72.1%) |
| None of the above | 29 (2.9%) |
| Number of Eligible Lesions per subject Enrolled | |
| 1 | 657 (65.4%) |
| 2 | 207 (20.6%) |
| 3 | 78 (7.8%) |
| 4 | 41 (4.1%) |
| 5 | 22 (2.2%) |
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Table 9 summarizes the lesion characteristics of patients in the study. In the DERM-SUCCESS pivotal study, lesions on the trunk constituted the majority of lesions, followed by lesions on the arms and head.
| Anatomic Location | n | % Anatomic Location | % Total |
|---|---|---|---|
| Head | 247 | 15.6% | |
| Scalp | 50 | 20.2% | 3.2% |
| Forehead | 59 | 23.9% | 3.7% |
| Cheek or nose | 85 | 34.4% | 5.4% |
| Chin | 8 | 3.2% | 0.5% |
| Other | 45 | 18.2% | 2.8% |
| Arm | 299 | 18.9% | |
| Upper Arm | 108 | 36.1% | 6.8% |
| Elbow | 11 | 3.7% | 0.7% |
| Forearm | 121 | 40.5% | 7.7% |
| Hand | 26 | 8.7% | 1.6% |
| Other | 33 | 11.0% | 2.1% |
| Leg | 207 | 13.1% | |
| Upper Leg | 66 | 31.9% | 4.2% |
| Lower Leg | 116 | 56.0% | 7.3% |
| Knee | 10 | 4.8% | 0.6% |
| Foot | 7 | 3.4% | 0.4% |
| Other | 8 | 3.9% | 0.5% |
| Trunk | 826 | 52.3% | |
| Neck | 63 | 7.6% | 4.0% |
| Chest | 128 | 15.5% | 8.1% |
| Upper Back | 361 | 43.7% | 22.9% |
| Lower Back | 149 | 18.0% | 9.4% |
| Abdomen | 64 | 7.7% | 4.1% |
| Pubic, Inguinal | 5 | 0.6% | 0.3% |
| Buttocks | 9 | 1.1% | 0.6% |
| Other | 47 | 5.7% | 3.0% |
Table 9: Lesion characteristics in DERM-SUCCESS pivotal study (mITT, n=1,579)
Table 10 summarizes the diagnoses of the lesions included in the study according to dermatopathology. The final pathology results were "high risk lesions" (high risk melanocytic lesions (melanoma and highly atypical nevi), SCC, and BCC). Consistent with the known occurrence rate, BCC was the most common lesion, with a slightly smaller number of SCC, and approximately one half the number of high risk melanocytic lesions.
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| Parent Pathology or Diagnosis | n (%) |
|---|---|
| High Risk Lesions | 224 (14.2%) |
| Melanoma and severely atypical nevi | 48 (3.0%) |
| Squamous Cell Carcinoma (SCC) | 86 (5.4%) |
| Basal Cell Carcinoma (BCC) | 90 (5.7%) |
| Low Risk Lesions | 1355 (85.8%) |
| Benign melanocytic nevus | 500 (36.9%) |
| Seborrheic keratosis | 490 (36.2%) |
| Actinic Keratosis (AK) | 71 (5.2%) |
| Lentigo | 65 (4.8%) |
| Other | 53 (3.9%) |
| Verruca / Wart | 48 (3.5%) |
| Dermatofibroma | 42 (3.1%) |
| Lichenoid keratosis | 29 (2.1%) |
| Angioma or vascular lesion | 20 (1.5%) |
| Categories with 1. The endpoint of sensitivity compared to the primary care physicians was selected to determine if the device provides superior sensitivity compared to primary care physicians. The second co-primary endpoint was selected to confirm that the performance was non-random. The secondary endpoint of the DERM-SUCCESS study was DermaSensor sensitivity compared to a performance goal of 90%. This endpoint was selected to compare the sensitivity of the DermaSensor device to that of the current gold standard for skin lesion evaluation, i.e., dermatologist evaluation, which literature review indicated is approximately 90%. |
Results of DERM-SUCCESS pivotal study
The DERM-SUCCESS pivotal study demonstrated an overall sensitivity of 95.5% when assessed over all ages and Fitzpatrick skin phototypes for identification of melanoma. SCC,
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or BCC. The first co-primary endpoint was met, as the device sensitivity for high-risk lesions, defined as the three target malignancies of melanoma (including highly atypical nevi), SCC, and BCC, across all ages and Fitzpatrick skin phototypes was 95.5%, which was superior to the sensitivity of PCPs for the same population (83.0%, p-value 1. The secondary endpoint was met, with overall sensitivity >90% ( 1. The secondary endpoint was met, with overall sensitivity >90%. A correlation was observed between the magnitude of the similarity score and positive predictive value. thereby meeting the second co-primary endpoint.
Safety
No adverse events were observed during the DERM-SUCCESS pivotal study. False negative and false positive device outcomes were not considered adverse events as part of the study due to the non-interventional design. However, false negatives would be considered adverse events during real world use of the device.
Adjunctive Use Performance Testing
Three studies were completed to assess performance of the device as an aid to PCPs. The first study was conducted with all lesions suggestive of skin cancer, per the indications for
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use, to demonstrate superior performance of the device-aided PCP compared to unaided PCPs. However, melanoma poses the highest risk of the three lesion types assessed due to a higher metastatic potential. higher morbidity, and higher mortality compared with SCC or BCC. Therefore, two additional reader studies were performed to ensure the device does not negatively impact the clinical decision of readers specifically in case sets enriched for pigmented lesions. Both studies were performed in a sequential read design to mimic the intended use of the device as a second read device.
DERM-SUCCESS initial reader study: "A Multi-Reader, Multi-Case (MRMC) Companion Study to the DERM-SUCCESS Clinical Study"
The DERM-SUCCESS initial reader study was intended to assess superiority of deviceaided PCPs over unaided PCPs across all skin cancers (melanoma, SCC, and BCC). The study included 108 readers trained in internal medicine or family practice who evaluated 25 malignant (20% melanoma, 40% SCC, 40% BCC) and 25 benign lesions. Readers were shown images of the lesions either with or without the device output in random order. All lesions were viewed twice during the study, once without device output and once with device output. After each lesion, the readers were asked to provide a management decision of "Refer" or "Do not refer." The co-primary endpoints were aided sensitivity superiority to unaided sensitivity, and aided sensitivity + specificity >1. The study demonstrated that:
- device-aided PCPs had a higher sensitivity of 91.4% (95% CI: 85.7-97.1%) . compared with unaided PCP sensitivity 82.0% (95% CI: 76.4-87.6%; p=0.0027); and
- sensitivity + specificity of PCPs aided by the device was greater than 1 (Odds Ratio . 6.8. CI: 4.7 to 9.8. p90%); by the PCP's use of the device output as a second read and in addition to all available clinical information and examination; and by the final management decision by the dermatologist to whom the patient is referred.
Benefits
The probable benefits of the device are based on nonclinical laboratory studies as well as data collected in the clinical studies described above.
The main benefit of the DermaSensor device is the demonstrated ability to improve the management decision of PCPs in the intended use population. In participants aged 40 and older with melanoma (including severely/highly atypical nevi), SCC, or BCC lesion(s), this benefit was indicated by high standalone device sensitivity (>90%), in a pivotal study that included a large number of participants and lesions (>1000 each) across 22 clinical sites and Fitzpatrick phototypes I-VI. Three reader studies demonstrated that use of the DermaSensor resulted in superiority of the aided PCP sensitivity over the unaided sensitivity of the same PCP and that the device led to a greater increase in true positive aided referral decisions than false negative aided referral decisions.
The clinical performance testing, including standalone device sensitivity and demonstrated aid in reader studies, supports the benefit of the DermaSensor device as a second-read adjunctive aid to
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primary care physicians in correct referral decisions for individuals aged 40 and over with melanoma (including highly atypical nevi), SCC, and BCC.
Uncertainty
The performance of the device has not been specifically evaluated in patients with increased risk for skin cancer, e.g., inherited or drug-induced photosensitivity; genetic predisposition to melanoma or BCC; immune compromise; or other medical conditions that increase the risk of skin cancer or its metastasis. Device-aided user performance may differ compared with the premarket studies provided, due to, for example, differences in reliance on the device in the real world compared to in the retrospective studies provided. Sensitivity of the DermaSensor device in participants under the age of 40 was less than 90%. Algorithm training and clinical testing had limited representation of patients with Fitzpatrick skin phototypes IV, V, and VI, reflective of the relative incidence of skin cancer in these patient subpopulations. This uncertainty is mitigated by the post-market surveillance special control and labeling which includes a precaution stating that limited data is available regarding the safety and effectiveness of the DermaSensor device for patients with Fitzpatrick skin phototypes IV, V, and VI and those at increased risk for skin cancer, e.g., inherited or drug-induced photosensitivity; genetic predisposition to melanoma or BCC; immune compromise; or other medical conditions that increase the risk of skin cancer or its metastasis.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, the data support that for the following indication statement:
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 probable benefits outweigh the probable risks for the DermaSensor device. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
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The De Novo request for the DermaSensor is granted, and the device is classified as follows:
Product Code: QZS Device Type: Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer. Regulation Number: 21 CFR 878.1830 Class: II