The DeepX DermoSight Dermatoscope is a non-invasive skin imaging system, which acquires white light dermatoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.

Device Description

The DeepX Health DermoSight Dermatoscope is designed to acquire images of the skin and optimize the imaging storage and documentation workflow. The DeepX Health DermoSight Dermatoscope system consists of a hardware device and a software application. The hardware device is a hand-held, dermatoscope (camera) for acquiring and transmitting images of the skin. The hand-held, portable unit includes an LED light-source, a digital camera and a USB cable to transfer images to a standard PC workstation. The device acquires optical dermatoscopic images in a contact mode (acquired with the device in contact with the skin). In addition, the device can also acquire a clinical close-up image, when it is positioned 15cm from the skin.

The stand-alone software application is cloud-based software with a related web application. The cloud software allows for storage and retrieval of the acquired images and patient data for review by medical professionals.

DeepX Health DermoSight Dermatoscope software is a stand-alone application to be accessed via a standard computer connected to the hospital/clinic server or directly to the internet.

The software displays the patient demographic and identification information (e.g., date of image acquisition and anatomic location of photographed site). The images and identification data may be output to the computer used for image acquisition or downloaded to an alternate computer or storage device identified by the user.

AI/ML Overview

The provided text describes the DeepX DermoSight Dermatoscope, a non-invasive skin imaging system, and its FDA 510(k) clearance process. However, the document does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or accuracy compared to predefined thresholds).

The document states that "The following documentation was submitted in the 510(k): Hardware Requirements Level of Concern Statement, Software Description, Software Architecture Specification, User Manual and Instructions for Use, Software Design Specification, Risk Analysis, Traceability Matrix, Software Validation Report, Usability Evaluation Report, Software Development and Lifecycle Plan, Unresolved Anomalies, Cybersecurity, Electromagnetic Compatibility and Safety, Biocompatibility Data."

This list indicates that various engineering, regulatory, and safety tests were performed, but it lacks the clinical or performance study details (e.g., accuracy against a gold standard or comparison with human readers) that would provide acceptance criteria and reported device performance metrics specifically for image interpretation or diagnostic accuracy.

Therefore, I cannot populate the table or answer most of the questions directly from the provided text.

Here's a breakdown of what can be extracted or inferred based on the document's content:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from general 510(k) process for this device type)	Reported Device Performance (Not explicitly stated in the document for specific image quality or diagnostic accuracy metrics)
Hardware Requirements Met	Documentation submitted: Hardware Requirements Level of Concern Statement
Software Description Provided	Documentation submitted: Software Description, Software Architecture Specification, Software Design Specification
Software Validation Completed	Documentation submitted: Software Validation Report
Usability Evaluated	Documentation submitted: Usability Evaluation Report
Risk Analysis Conducted	Documentation submitted: Risk Analysis, Traceability Matrix
Cybersecurity Addressed	Documentation submitted: Cybersecurity
Electromagnetic Compatibility and Safety Met	Documentation submitted: Electromagnetic Compatibility and Safety (IEC 60601-1-2:2014 and EN 60601-1-2:2015 compliant)
Biocompatibility Met	Documentation submitted: Biocompatibility Data (ISO 10993 for tissue contact nose piece and spacer)
Electrical Safety Met	Documentation submitted: Electrical safety (IEC 60601 compliant)
Substantial Equivalence to Predicate Device for Intended Use, Technological Characteristics, and Performance	Stated in Conclusion: "The DeeX Health DermoSight Dermatoscope system is substantially equivalent to the previously cleared Demetra BDEM-01 Image Processing System with respect to intended use, general technological characteristics and performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document lists "Software Validation Report" and "Usability Evaluation Report" as submitted documentation, but it does not detail the methodology, sample size, or data provenance for these tests. There is no mention of a clinical or retrospective/prospective study with a test set of images for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. Given that there's no described performance study (e.g., for diagnostic accuracy), there's no mention of experts establishing ground truth for such a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided. (See #3)

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No evidence of an MRMC study. This device is a dermatoscope and an archiving system; it's explicitly stated to be for "acquiring, storing, retrieving, displaying and reviewing" by trained medical practitioners. It does not appear to incorporate AI for image analysis or diagnostic assistance, so an MRMC study comparing human readers with and without AI assistance is not applicable based on the provided information.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No evidence of a standalone algorithm performance study. The device description focuses on image acquisition, storage, and display for review by medical practitioners, implying it is a tool for human review, not a standalone diagnostic AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated for performance metrics. For the various engineering tests (software validation, usability, safety), the ground truth would be adherence to specified requirements, standards, and safety regulations. However, for diagnostic accuracy, no such ground truth establishment is described.

8. The sample size for the training set

Not applicable / Not provided. Since there's no mention of an AI algorithm requiring a training set for diagnostic purposes, this information is not present. The software is described as for "Image acquisition, Image transfer, Image and patient data storage and retrieval, Image display and comparison."

9. How the ground truth for the training set was established

Not applicable / Not provided. (See #8)

Summary of what the document focuses on regarding performance:

The document emphasizes that DeepX DermoSight Dermatoscope is substantially equivalent to a previously cleared predicate device (Demetra BDEM-01). The "Performance Testing" section lists various engineering and regulatory reports (e.g., Software Validation, Cybersecurity, Biocompatibility), which are typical for demonstrating safety and effectiveness for a 510(k) clearance, especially for a device primarily focused on image acquisition, storage, and display rather than automated diagnosis. The comparison table directly addresses the technical specifications and intended use against the predicate, highlighting similarities rather than presenting novel performance metrics against a clinical gold standard.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 17, 2023

DeepX Health LLC % Howard Schrayer Official Correspondent 8 Lookout Hilton Head Island, South Carolina 29928

Re: K230448

Trade/Device Name: DeepX DermoSight Dermatoscope Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: PSN Dated: February 20, 2023 Received: February 21, 2023

Dear Howard Schrayer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Carr -S

Jessica Carr, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230488

Device Name DeepX DermoSight Dermatoscope

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Exhibit E - 510(k) Summary

Contact:	Howard SchrayerDeepX Health LLC2101 L Street, NW Suite 300Washington, DC 20037Telephone: 609-273-7350hs.ss@lucidmedical.net
Date Prepared:	February 20, 2023
Device Trade Name:	DermoSight Dermatoscope
Manufacturer:	DeepX Health LLC2101 L Street, NW Suite 300Washington, DC 20037
Common Name:	Light Based Imaging - Surgical Lamp
Classification:	Class II
Product Code:	PSN
Regulation:	21 CFR 878.4580
Predicate Devices:Primary Predicate	Demetra BDEM-01Surgical Lamp[510(k) K192829]
Reference Predicate	Visiomed AGMicroDERM® Model/Version 3.5[510(k) K040171]

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Indications for Use:

The DeepX DermoSight Dermatoscope is a non-invasive skin imaging system. which acquires white light dermatoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.

Device Description:

DeepX Health DermoSight Dermatoscope software is a stand-alone application to be accessed via a standard computer connected to the hospital/clinic server or directly to the internet.

Substantial Equivalence and Predicate Devices:

The device was shown to be substantially equivalent to a previously cleared light based imaging devices, specifically including the Demetra BDEM-01 system [510(k) K192829] predicate and the Visiomed AG MicroDERM® Model/Version 3.5 [510(k) K040171].

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Performance Testing:

The following documentation was submitted in the 510(k).

Hardware Requirements Level of Concern Statement Software Description Software Architecture Specification User Manual and Instructions for Use Software Design Specification Risk Analysis Traceability Matrix Software Validation Report Usability Evaluation Report Software Development and Lifecycle Plan Unresolved Anomalies Cybersecurity Electromagnetic Compatibility and Safety Biocompatibility Data

Predicate Comparison Table

Manufacturer	DeepX Health LLC	Demetra
Trade Name	DeepX HealthDermoSight Dermatoscope	Demetra BDEM-01
510(k) Number	Subject Device - TBD	K192829
Regulatory Class	Class II	Class II
Regulation	21 CFR 878.4580	21 CFR 878.4580
Type of Device/Product Code /Regulation	Light Based ImagingSurgical LampPSN21 CFR 878.4580	Light Based ImagingSurgical LampPSN21 CFR 878.4580
Indications forUse	The DeepX DermoSightDermatoscope is a non-invasiveskin imaging system, whichacquires white lightdermatoscopic images andclinical photographs of the skin.These can be stored, retrieved,displayed and reviewed bytrained medical practitioners.	The Barco DermoSightDermatoscope is a noninvasiveskin imagingsystem, which acquiresmultispectral and white lightdermatoscopic images andclinical photographs of the skin.These can be stored, retrieved,displayed and reviewed bytrained medical practitioners.
Intended Use(From Regulation)	A surgical lamp (including afixture) is a device intended tobe used to provide visible	A surgical lamp (including afixture) is a device intended tobe used to provide visible
	illumination of the surgical fieldor the patient.Emission and collection of lightto create an image for medicalpurposes	illumination of the surgical fieldor the patient.Emission and collection of lightto create an image for medicalpurposes
Intended Users	Trained medical practitioners	Trained medical practitioners
Mechanism of Action	Acquire and display of digitalvideo images	Acquire and display of digitalvideo images
Form of HardwareComponent ofDevice	The hardware device is aportable, battery poweredmedical device for acquiring andvisualizing images of the skin.	The hardware device is aportable, battery poweredmedical device for acquiring andvisualizing images of the skin.
DermoSightCameraResolution	5mp 2592 x 1944CMOS sensor	8mp 3840 x 2160CMOS sensor
Light Source	White light LEDs	White light LEDsMultispectral LEDs
Data transfer	Camera to PC via USB cable	FCC compliant wireless
Software location	Cloud based	Cloud based
Functions	Image acquisitionImage transferImage and patient data storageand retrievalImage display and comparison	Image acquisitionImage transferImage and patient data storageand retrievalImage display and comparison
Use environment	Professional medicalenvironment	Professional medicalenvironment
HardwareLocation	PC inserted between imagesource (camera) and internetconnection	PC inserted between imagesource (camera) and internetconnection
Body contact	Unbroken skin	Unbroken skin
User interface	Proprietary software for entryand retrieval of patientidentification, lesion location andimages	Proprietary software for entryand retrieval of patientidentification, lesion location andimages
Biocompatibility	ISO 10993 for tissue contactnose piece and spacer	ISO 10993 for tissue contactnose piece
Environmentalcompatibility	IEC 60601-1-2:2014 and EN60601-1-2:2015 compliant	IEC 60601-1-2:2014 and EN60601-1-2:2015 compliant
Electrical safety	IEC 60601 compliant	IEC 60601 compliant

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Conclusion

The DeeX Health DermoSight Dermatoscope system is substantially equivalent to the previously cleared Demetra BDEM-01 Image Processing System with respect to intended use, general technological characteristics and performance.

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.