Search Results
Found 1 results
510(k) Data Aggregation
(134 days)
MICRODERM, MODEL/VERSION 3.5
MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.
MicroDERM® is a digital dermascope and software system, which captures images of skin surfaces for physician diagnostic review and referral purposes. These images can be sent to other computers using a modem or network card. It consists of the MicroDERM® camera, MicroDERM® software, and a frame grabber card. The MicroDERM® software runs under the Microsoft® Windows 2000 operating system. MicroDERM is not intended as a diagnostic device.
This document is a 510(k) premarket notification for the MicroDERM® device, which is a digital dermascope and software system. The document states that the device is not intended as a diagnostic device, but rather for the acquisition and storage of images of skin surfaces. Therefore, the acceptance criteria and related studies provided are focused on performance standards for medical devices generally, rather than diagnostic accuracy metrics.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Standard | Reported Device Performance |
|---|---|
| ISO 9001:1994 Quality Systems | The MicroDERM System has been tested to and meets this standard. |
| ISO 13485 Quality Systems, Medical Devices- Particular application to the Requirements of 90001 | The MicroDERM System has been tested to and meets this standard. |
| EN 14971 Risk Analysis | The MicroDERM System has been tested to and meets this standard. |
| EN 46001 Quality Systems Application of 9001 to Medical devices | The MicroDERM System has been tested to and meets this standard. |
| IEC 10918-1 Information technology -- Digital compression and coding of continuous-tone still images: Requirements and guidelines | The MicroDERM System has been tested to and meets this standard. (Indicates images are saved using standard JPEG compression algorithms). |
| IEC 60601- Electrical Safety and Electromagnetic Compatibility | The MicroDERM System has been tested to and meets this standard. |
| 21CFR820 Quality System Regulation | The MicroDERM System has been tested to and meets this standard. |
| FDA ODE Guidance on the Content of Pre-market submissions for devices containing Software: 1998 | The MicroDERM System has been tested to and meets this standard. |
| FDA Guidance of use of Off The Shelf Software in Medical Devices; 1997 | The MicroDERM System has been tested to and meets this standard. |
| FDA Guidance for the Submission of Pre-Market Notification for Medical Image Management Devices: 2000 | The MicroDERM System has been tested to and meets this standard. |
| 21CFR1020.10 As applicable to Video Monitors | The MicroDERM System has been tested to and meets this standard. |
| 21CFR1040.10 As applicable to Optical Storage Devices | The MicroDERM System has been tested to and meets this standard. |
| 21CFR810 Labeling | The MicroDERM System has been tested to and meets this standard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily focuses on compliance with general medical device standards and does not detail a clinical test set or data provenance for evaluative purposes.
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)
This information is not provided in the document. Since the device is not intended for diagnosis, the concept of "ground truth" for patient outcomes or conditions in a clinical study is not applicable in the context of the provided information.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The MicroDERM is described as an image acquisition and storage device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation related to diagnostic accuracy or clinical outcomes was not performed, nor is it relevant given the stated indications for use. The "Performance Standards" listed are for medical device quality systems, electrical safety, and image handling, not for AI algorithm performance. The device is explicitly stated as "not intended as a diagnostic device."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided and is not applicable in the context of the device's stated purpose as an image acquisition and storage system, rather than a diagnostic tool.
8. The sample size for the training set
This information is not provided in the document. Since the device is not an AI-based diagnostic tool, a "training set" in that sense would not be relevant.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no indication of an AI-based diagnostic algorithm requiring a training set with established ground truth.
Ask a specific question about this device
Page 1 of 1