(15 days)
FCA is an aiding tool for the clinicians to perform analysis of sets of stationary. dynamic, or gated PET transaxial images via a number of display, measurement and batch filming/archive features. The measurements include perfusion, enddiastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation. Also included is to enable clinicians to visualize reformatted PET perfusion and viability data, make a comparison between the two. The perfusion or viability data could have been acquired under stress or rest conditions and they can be processed individually or simultaneously.
FCA allows users to customize their screens. Also, the users can export a selected set of short axis images in DICOM compliant format. These images can then be processed by an external software package to perform regional quantitative analysis, absolute and relative ratio maps of each region of the heart and topographic maps. Finally, it aids clinicians to capture the summary of quantitative and qualitative results from the study in a single summary page,
The physiological and functional data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners.
In summary, FCA is intended to aid clinicians in the assessment of physiological data and in refining their clinical decisions based on the quantitative and qualitative assessment of stationary, dynamic, and gated PET images.
FullCard Analysis (FCA) is a post processing analysis software package designed to assist Radiologists, Nuclear Medicine Doctors, Cardiologists, and other clinicians by offering a totally integrated package including automated processing, visualization, quantification of parameters of myocardial perfusion and function, along with simple reporting capabilities. The parameters include perfusion, end-diastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation.
FCA accepts Gated PET images in either transaxial or short axis orientations. The package processes images automatically but it allows the users to intervene and modify results when needed. FCA is a software post-processing package for the Advantage Workstation (AW) platform and PET/CT scanners.
The provided document, K061587 for the GE Healthcare FullCard Analysis (FCA) device, is a 510(k) summary submitted for substantial equivalence to predicate devices. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive details on novel performance studies to meet explicit acceptance criteria.
Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, a dedicated study proving performance against these criteria, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies.
The "Conclusions" section explicitly states: "FullCard Analysis does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of FCA to be equivalent to those of ECToolbox with HeartFusion and Xeleris 2 Processing and Review Workstation, Advantage Workstation 4.3, and Positron mPower."
Here's an attempt to answer your questions based on the limited information available in a 510(k) summary for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or a direct performance table are provided in this 510(k) summary. The submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly considered to be equivalent to the performance of the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary for this device. For substantial equivalence, specific performance studies with detailed test sets are often not required. The submission focuses on device description, indications for use, and comparison to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission, a dedicated "ground truth" establishment for a new test set is not typically detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the 510(k) summary. This type of study would typically be part of a more extensive performance evaluation, which is not the primary focus of a substantial equivalence filing for a post-processing software package like FCA.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study is not explicitly mentioned in the 510(k) summary. The device is described as an "aiding tool for the clinicians," suggesting human-in-the-loop is inherent to its intended use. The focus is on the software's ability to assist clinicians in analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the 510(k) summary.
8. The sample size for the training set
This information is not provided in the 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided in the 510(k) summary.
§ 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.