(25 days)
The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.
The software is deployed via medical imaging workstations and is organized as a series of workflows which are specific to use with particular drug and disease combinations.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET and SPECT studies.
Scenium 1.1 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.
The software is post processing and does not control the scanning features of the system.
The provided text is a 510(k) summary for the Scenium 1.1 software and does not contain information about acceptance criteria or specific study results to prove device performance.
The document focuses on:
- Company contact details
- Identification of the product and its classification
- Comparison to predicate devices
- Device description
- Indications for Use
- Technological characteristics (stating similarity to predicate devices)
- Safety and effectiveness concerns (mentioning compliance with regulations and standards)
- A statement of substantial equivalence to predicate devices.
- The FDA's decision letter confirming substantial equivalence.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information from the provided document.
The document generally asserts substantial equivalence based on similar uses, applications, and features to predicate devices, and compliance with regulatory standards (21 CFR § 820, 21 CFR 892.1200, 21 CFR 892.2050, and BS EN ISO 14971:2001). However, it does not present a specific study with defined acceptance criteria and corresponding performance metrics for the Scenium 1.1 software itself.
§ 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.