(24 days)
The HERMES HDAQ Acquisition Station is a system designed to acquire nuclear medicine image data using a compatible gamma camera system. The HERMES Workstation is a system designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or HDAQ acquisition stations.
The HERMES system consists of two components, a data acquisition station and a computer workstation. The HERMES HDAQ acquisition station and workstation are designed for use with commercially available gamma cameras. Software applications control acquisition, processing, display, analysis, and management of data and can be connected via network to other vendors' medical imaging workstations.
The provided 510(k) summary for the HERMES HDAQ Acquisition Station and HERMES Workstation, Ver. 3.4 does not include information about specific acceptance criteria or an explicit study proving performance against such criteria.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (HERMES HDAQ Acquisition Station and HERMES Workstation, K002782) based on the following:
- Same intended use: The modified device (Ver. 3.4) has the same intended use as the original device.
- Same technological characteristics: The document states, "The technological characteristics of the modified device are the same as the original device." The modification is explicitly stated as "the addition of six additional software applications."
- Device testing: The summary mentions, "Testing of the modified device followed Nuclear Djagnostic AB's normal procedures. A test plan was developed containing a description of relevant test procedures. Test results were documented, including what was tested, expected results, who performed the test, and which resources were used (i.e., automated test tools)." However, it does not provide details about what was tested, what the expected results were, or the actual results that would constitute acceptance criteria.
Therefore, I cannot provide the requested table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample size, ground truth, expert opinions, or comparative effectiveness studies, as these types of detailed performance studies were not a part of this 510(k) submission for substantial equivalence.
This submission is based on the premise that since the modified device's core technological characteristics and intended use are the same as the predicate, and new software applications operate independently, a detailed performance study like those for entirely new devices or those with significant changes impacting clinical performance were not required for this type of 510(k) clearance.
§ 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.