(31 days)
The ImagenMD™ system is a software and computer system that allows the user to view myocardial perfusion SPEC or PET images from a remote location. The system allows the user to view quantify and process perfusion and gated SPECT images.
ImagenMD™ is a software application installed on laptop computers which allows physicians and healthcare professionals to view myocardial perfusion SPECT or PET images from their office, hospital or home. The system processes perfusion and gated SPECT performing quantitative data analysis. The user can select raw, short axis, transmission slice and gated short axis studies for the purpose of examining those images for abnormalities and artifacts. The system contains optional databases which quantify the extent and severity of myocardial defects. Also included is an application for the display and analysis of gated short axis blood pool SPECT datasets. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
The provided document does not contain information regarding a specific study with acceptance criteria and reported device performance. It is a 510(k) summary for the ImagenMD™ system, which primarily focuses on establishing substantial equivalence to predicate devices rather than presenting detailed clinical trial results or performance metrics against defined acceptance criteria.
The document describes the device, its indications for use, and compares its technical characteristics to predicate devices (AutoQUANT, SeeMor, QBS). It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone (algorithm only) performance study details.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a regulatory submission for premarket notification (510(k)), which typically demonstrates equivalence to existing legally marketed devices rather than providing the detailed clinical study data often found in PMA submissions or peer-reviewed publications.
§ 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.