(90 days)
The IMNET DICOM Network Agent is a software device intended for use within the medical imaging environment. The product is a communication tool which facilitates the transfer of medical images from one system to another. Receiving medical images from a DICOM source and transmitting them to another DICOM compatible target, the product is a communication gateway for the DICOM environment.
The IMNET DICOM Network Agent is a software device intended for use within the medical imaging environment. The product is a communication tool which facilitates the transfer of medical images from one system to another. Receiving medical images from a DICOM source and transmitting them to another DICOM compatible target, the product is a communication gateway for the DICOM environment.
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) clearance letter from the FDA for the "Imnet Dicom Network Agent." It confirms that the device is substantially equivalent to legally marketed predicate devices. The second document, "EXHIBIT G: USE FORM," describes the "Indications for Use" for the device, stating it's a software device intended for transferring medical images between DICOM-compatible systems.
This type of regulatory document typically focuses on substantial equivalence to a predicate device rather than detailed performance studies and acceptance criteria as would be found in a clinical trial report or a comprehensive technical specification.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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: Not mentioned. The device is described as a "communication tool" and "communication gateway," not an AI-powered diagnostic or assistive tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.