(84 days)
The AutoSPECT Plus with InStill Motion Correction option to the ADAC Gamma Camera Systems produces images which depict anatomical density of the patient. This system is intended to provide enhancements of gamma camera emission images by automating previously manual image processing functions and providing manual and automated motion correction.
The AutoSPECT Plus with InStill Motion Correction software option enables automatic processing of one or more cardiac SPECT, gated SPECT, Vantage SPECT, MCD, or MCD-AC cardiac data sets. In addition. AutoSPECT Plus with InStill Motion Correction enables the manual processing of one or more SPECT. gated SPECT, Vantage SPECT, MCD, or MCD-AC data sets. The basic data processing algorithms utilized by AutoSPECT Plus with InStill Motion Correction are ones which have been utilized in previously cleared ADAC products.
For automatically processing cardiac data sets, AutoSPECT Plus with InStill Motion Correction provides three options. The first of these options, "Auto All", automatically determines the reconstruction limits, reconstructs and reorients the cardiac data sets and creates the short axis, horizontal long axis and vertical long axis data sets. The second option, "Auto Recon", automatically determines the reconstruction limits and reconstructs the cardiac data sets. The third option. "Auto Reorient", automatically reorients the cardiac transverse data sets. If necessary, AutoSPECT Plus with InStill Motion Correction reconstructs the data sets prior to re-orientation.
AutoSPECT Plus with InStill Motion Correction software also allows the user to process noncardiac SPECT, Vantage, MCD, or MCD-AC data sets. In this case, the operator manually positions the reconstruction limit lines to reconstruct transverse data sets. If necessary, the data set can be reoriented by manually positioning the Azimuth and elevation lines to the desired location.
The AutoSPECT Plus with InStill Motion Correction software will also process groups of SPECT data sets in a batch mode fashion. Once the operator has selected the data sets and determined the processing method (i.e. Auto All, Auto Recon, Reorient, or Reconstruct), AutoSPECT Plus with InStill Motion Correction processes the first data set followed by all remaining data sets without further interaction from the operator.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The document is primarily a 510(k) summary for the "AutoSPECT Plus with InStill Motion Correction" device, focusing on its substantial equivalence to predicate devices and its intended use.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria are explicitly stated in the document (e.g., a specific accuracy, sensitivity, or specificity threshold).
- No quantitative device performance metrics (e.g., reported accuracy, sensitivity, specificity) are provided. The "Testing" section only vaguely states: "Images were processed using the AutoSPECT Plus with and without InStill Motion Correction."
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not mentioned.
- Data provenance (e.g., country of origin, retrospective or prospective): Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not mentioned.
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
- The document implies a comparison ("with and without InStill Motion Correction"), but it does not describe an MRMC comparative effectiveness study involving human readers. It focuses on the processing of images by the device itself, not human interpretation aided by the device. Therefore, no effect size for human reader improvement is provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Based on the description, the device performs "automatic processing" and "automated motion correction." The "Testing" section suggests evaluating the output of this automated processing. This implies a standalone algorithm only evaluation, but no performance metrics are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not mentioned. Given the nature of a SPECT image processing and motion correction device, "ground truth" would likely involve expert visual assessment of image quality, artifact reduction, or quantitative metrics derived from the images, but this is not specified.
8. The sample size for the training set
- Not mentioned.
9. How the ground truth for the training set was established
- Training set details and ground truth establishment methodology are not mentioned.
§ 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.