(85 days)
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.
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.
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.
§ 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.