(77 days)
ID.Store is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS).
ID.Store may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).
The ID.Store device is a software package composed of several application modules which work in tandem using a distributed storage architecture to control the archival storage and retrieval of digitized medical images. The ID.gate (gateway), ID.store (archiving), and ID.dbs (image database manager) modules communicate with each other using the dedicated administrative communication protocol ImageTalk. Permanent archival storage media supported include CD-R, WORM, MOD/WORM, DVD, etc. Recommended hardware are standard general purpose equipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devices for temporary data storage.
The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets them. The document is primarily a 510(k) summary for the "ID.Store" device, focusing on its intended use, description, comparison to a predicate device, and regulatory approval.
Specifically, the text is a 510(k) summary for the "ID.Store" (PACS Component Software) and letters from the FDA regarding its clearance. It describes the device's function as software for archival storage and retrieval of digital medical images within a PACS, and states its substantial equivalence to a predicate device (Kodak Medical Image and Information Library (MIIL)).
Therefore, I cannot provide the requested information, which typically involves performance metrics, study design, and ground truth establishment. This type of information is usually found in detailed performance studies or validation reports, which are not part of this 510(k) summary.
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(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.