(88 days)
The MAPS 10000 is intended to acquire, process, display and maintain nuclear imaging studies obtained using compatible gamma camera systems.
The MAPS 10000 is designed to acquire nuclear images as well as provide image display and processing, database utilities, and archiving utilities of nuclear imaging studies obtained using compatible existing acquisition software (subsystem) and gamma cameras. It is designed to be compatible with networked gamma camera and analogue camera systems using a windows-based operating system.
MAPS 10000 includes a software program used to archive new nuclear imaging studies on a local disc drive or networked disc drive, to perform file management tasks on existing patient studies and data files (select, protect, copy, move, delete, and print); to import foreign patient studies and data; to display and process studies and data files; and to run pre-set and user-defined image protocols.
The provided text does not contain information related to acceptance criteria or studies performed to prove the device meets specific performance metrics.
The document is a 510(k) summary for the MAPS 10000 Gamma Camera System, which primarily focuses on establishing "substantial equivalence" to predicate devices. It describes the device's general function (acquiring, processing, displaying, and maintaining nuclear imaging studies), its classification, and its intended use.
Specifically, the "Testing" section {2} states: "Images were acquired, processed, and displayed using MAPS 10000." This is a very general statement and does not provide any detailed information about:
- Acceptance Criteria: What specific performance metrics were tested (e.g., image quality, processing speed, accuracy of measurements).
- Study Design: How the testing was conducted, what data was used, or what statistical analyses were performed.
- Performance Results: Any quantitative or qualitative results from the testing to demonstrate performance against specific criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.
The FDA letter {2} also confirms the substantial equivalence determination but does not delve into the specifics of the performance testing.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.