(87 days)
The Kodak Digital Science™ (KDS) ImageVIEW is a network-oriented client/server type PACS system for the distribution, viewing, and printing of medical images at distributed locations.
The Kodak Digital Science™ (KDS) ImageVIEW family of products is designed to facilitate the distribution of images from standard DICOM storage devices within the radiology department and provide controlled Internet access to images stored on DICOM storage devices. Browser extensions will allow dynamic viewing and manipulation of these medical images. This family of products will initially provide image viewing and referral printing functionality to referring and clinical physicians, but will be extended to provide diagnostic viewing and printing functionality for radiology use. They will also provide intelligent management of images and information to facilitate productivity enhancements for its users. ImageVIEWs are not represented to be of use in supporting or sustaining human life, nor do they represent a potential of unreasonable risk of illness or injury.
The provided text describes the Kodak Digital Science™ (KDS) ImageVIEW, a Picture Archiving and Communications Systems (PACS) component. However, the document is a 510(k) summary for premarket notification, indicating substantial equivalence to a predicate device, rather than a study report detailing specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information required to populate the tables and answer the questions regarding acceptance criteria, device performance, or study details.
The text states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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)." This indicates that the device was cleared based on its equivalence to a predicate device, not necessarily on a new clinical study assessing specific performance metrics against pre-defined acceptance criteria.
Information not found in the document:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study information.
- Standalone performance details.
- Type of ground truth used.
- How ground truth for the training set was established.
§ 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.