(168 days)
HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
The base product design of Hermes Medical Imaging Suite v5.7 is the same as for the Hermes Medical Imaging Suite v5.6 (K153056). The following modules have been added in this applicatio to Hybrid Viewer NM Processing: Colonic Transit, Remnant Liver, Parathyroid, Dosimetry, Classic DMSA, Oesophageal Transit/Reflux, HIDA, Salivary Gland, Bone3Phase Analysis and Uniformity.
Here's an analysis of the provided text regarding the acceptance criteria and study details for the Hermes Medical Imaging Suite v5.7:
Understanding the Device:
The device, HERMES Medical Imaging Suite v5.7, is a software application suite for processing, displaying, analyzing, and managing nuclear medicine and other medical imaging data. It has added several new modules compared to its predecessor (v5.6).
Challenges in Extracting Information:
The provided text is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device. It doesn't present a traditional "acceptance criteria" table or a single, comprehensive study report with detailed methodologies. Instead, it describes a series of comparative tests against predicate devices and manual calculations. Therefore, the "acceptance criteria" are implied by the comparisons and the statement that "the testing results supports that all the software specifications have met the acceptance criteria." The reported performance is the outcome of these comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
| Module/Function Tested | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Hybrid Recon (Myocardial SPECT) | High correlation (Pearson correlation coefficient r close to 1) with predicate v5.6 for QPS parameters (SSS, Stress volume, Stress Area, Stress Defect Area, SRS, Rest Volume, Rest Area, Rest Defect Area). | Pearson correlation coefficient r between 0.96 to 0.99 with Hybrid Recon in Medical Imaging Suite v5.6. |
| Hybrid Recon (Phantom Studies) | Similar accuracy in activity concentration calculation to predicate v5.6, particularly for larger targets. | Jaszczak Phantom: Average error between reconstructed and true activity concentration: -3.5% with v5.6, -1.1% with v5.7. |
| IEC Phantom: Error of reconstructed activity concentration around 5% for large enough targets; reduced accuracy in small targets due to partial volume effect (as expected). | ||
| Classic DMSA | Maximum percentage difference in relative function values with predicate v5.3's Classic DMSA application should be small. | Maximum % difference between Classic DMSA in v5.7 and Classic DMSA in v5.3 for relative function values is ** |
§ 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.