(168 days)
Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
The Lung Lobe Quantification module in Hybrid 3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function.
The provided text is a 510(k) summary for the Hybrid3D device, specifically focusing on its Lung Lobe Quantification module. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and how they were met.
The document broadly states:
- "The testing results supports that all the software specifications have met the acceptance criteria." (Page 4, Section H)
- "Comparisons were made between the module Lung Lobe Quantification in Hybrid3D v1.0 and Hermes Medical Imaging Suite v5.6 (K153056), Hybrid3D v1.0 and PMOD. The results showed a good compliance." (Page 4, Section I)
This general statement indicates that testing was performed and acceptance criteria were met, but it does not provide the specifics of those criteria, the reported device performance, sample sizes, expert qualifications, or adjudication methods.
Therefore, I cannot extract the information required for your request from the provided text. To answer your questions, I would need a more detailed scientific or clinical study report, which is typically found in the full 510(k) submission, but not in this summary document.
§ 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.