(87 days)
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.
ACQA is a software application installed on GE Advantage Windows workstation computers which allows physicians and healthcare professionals (1) to create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images, and (2) to register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images. 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.
Here's a breakdown of the acceptance criteria and study findings for the ACQA system, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the ACQA system is a general summary and does not include specific quantitative acceptance criteria or detailed performance metrics. However, it does state a general conclusion:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets specifications | "The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications." |
| Functionality (Attenuation Correction) | "create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images" |
| Functionality (Image Registration) | "register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images." |
| Safety & Effectiveness (Assisted Reading) | "The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physician read the original PET images." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary mentions "both laboratory and clinical data sets" were used for testing. However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The 510(k) summary does not provide information on the number of experts used to establish ground truth or their qualifications for the test set.
4. Adjudication Method for the Test Set
The 510(k) summary does not provide information on the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it quantify an effect size for human readers improving with AI vs. without AI assistance. The device is described as assisting physicians, but direct comparison of physician performance with and without the tool is not detailed.
6. Standalone (Algorithm Only) Performance Study
The 510(k) summary indicates that the ACQA system performs specific functions (creating averaged CT images and registering images) as a software application. The statement "The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications" implies some form of standalone performance evaluation of these technical functionalities. However, it doesn't explicitly detail a standalone performance study in terms of traditional diagnostic metrics (e.g., sensitivity, specificity) for a clinical diagnosis, as the output is described as "secondary data set to assist the physician read the original PET images."
7. Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used. Given the device's function (attenuation correction and image registration), the "ground truth" would likely relate to the accuracy of these technical tasks rather than a clinical diagnosis. This could involve:
* Image registration accuracy metrics: Comparing the alignment achieved by ACQA to a manually confirmed or gold-standard registration.
* Attenuation correction accuracy: Comparing PET images corrected by ACQA to those corrected by established methods or phantoms with known attenuation properties.
8. Sample Size for the Training Set
The 510(k) summary does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The 510(k) summary does not provide information on how the ground truth for the training set was established. Given the nature of the device (software for image processing, not a diagnostic AI system predicting disease), it's possible that the "training set" in the context of this device refers to data used for algorithm development and testing of technical parameters, rather than a clinical ground truth labeling.
§ 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.