(64 days)
StatNet is intended for the storage, distribution to any of several work stations, viewing, interpretation and annotation of X-ray of coronary anatomy that have been obtained in coronary catheterization laboratories and written on DICOM-3 CD-ROM media.
StatNet is a network of image display, processing, and archiving modules composed of general purpose, personal computer level, digital hardware; commercial, general purpose digital communication hardware; general purpose operating systems and communications software; medical image analysis and processing software developed by others; and proprietary software modules developed by GORCA that integrate the preceding components into a complete system. Images enter the network on DICOM-3 CD-ROM media.
The provided text describes a PACS system called StatNet and compares its features to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria for device performance, nor a study proving it meets such criteria. The document is a 510(k) summary, which focuses on device description and comparison to predicates for regulatory clearance, not performance validation studies against specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance, as this information is not present in the provided text.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.