(29 days)
The ImagenSPECT™ 3.0 system is a software application that provides a processing environment for the analysis and display of cardiac SPECT and planar images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT 3.0 is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. This software can also be used for processing display and quantitation of multigated acquisition blood pool scans (MUGA) specifically the left ventricular ejection fraction (LVEF). ImagenSPECT™ 3.0 can also be used for quantitation of planar and SPECT, early and late 99mTc pyrophosphate images.
ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The 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. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECTT™ 3.0 is used to quantitate the uptake of 99™Tc pyrophosphate in early and late planar and SPECT studies. The ImagenSPECTTM 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (K152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).
Here's a breakdown of the acceptance criteria and the study details for ImagenSPECT™ 3.0, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes comparative studies against predicate devices and statistical measures of agreement and difference. I will present the reported performance and infer the implicit acceptance criteria based on these comparisons.
| Feature / Metric | Implicit Acceptance Criteria (Inferred) | Reported Device Performance and Statistical Significance |
|---|---|---|
| 99mTc pyrophosphate heart contralateral ratios | High correlation and no significant statistical difference compared to predicate. | Pearson correlation coefficient (r) = 0.96 (between ImagenSPECT 3.0 and Siemens e.soft). P-value for student paired t-test = 0.15 (indicating no statistically significant difference). |
| MUGA derived LVEF measurements | High correlation and no significant statistical difference compared to predicate. | Pearson correlation coefficient (r) = 0.92 (between ImagenSPECT 3.0 and Siemens e.soft). P-value = 0.13 (indicating no statistically significant difference). |
| One-quarter time myocardial perfusion SPECT (phantom study) | Signal-to-noise ratio effectively preserved compared to full-time scans. | 98.9% of the signal-to-noise using one-quarter time reconstructed with ImagenSPECT 3.0 when compared to full-time unfiltered reconstructed perfusion images. |
| One-quarter time myocardial perfusion SPECT (patient study - segmental difference) | Low average segmental difference and no significant statistical difference compared to conventional OSEM reconstructions. | Average segmental difference between full-time OSEM and one-quarter time ImagenSPECT 3.0 was 5.9%. P-value of the paired t-test = 0.76 (indicating no statistically significant difference). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set for each study. It indicates that the studies involved:
- "patient data" for 99mTc pyrophosphate and MUGA LVEF comparisons.
- "patient studies" for the one-quarter time myocardial perfusion SPECT evaluation.
- "phantom studies" for the one-quarter time myocardial perfusion SPECT signal-to-noise ratio.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the comparison to the Siemens e.soft system, it's likely the data was collected in a clinical setting in a country where such systems are used, but specific details are absent. The nature of the studies (comparison to existing methods) suggests they could be retrospective analyses of existing patient data, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Instead, the ground truth appears to be established by the measurements obtained from the predicate Siemens e.soft system or conventional OSEM reconstructions, which are presumably considered the clinical standard.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The comparisons are statistical correlations and t-tests against established methods, not against expert consensus that would typically require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies described focus on the algorithm's performance in comparison to predicate systems, not on how human readers' performance improves with or without AI assistance.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are primarily standalone (algorithm only) performance evaluations. ImagenSPECT™ 3.0's calculations and reconstructions (e.g., heart contralateral ratios, LVEF, one-quarter time SPECT) are directly compared against the results from predicate systems (Siemens e.soft, conventional OSEM). There is no mention of human-in-the-loop performance evaluation in these specific studies.
7. The Type of Ground Truth Used
The ground truth used in these studies appears to be based on:
- Measurements from legally marketed predicate devices: Siemens e.soft system for 99mTc pyrophosphate heart contralateral ratios and MUGA derived LVEF.
- Conventional reconstruction methods: Full-time unfiltered reconstructed perfusion images and conventional ordered subsets expectation maximization (OSEM) reconstructions for one-quarter time myocardial perfusion SPECT.
This can be broadly categorized as "predicate device/method comparison" rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not specify the sample size for any training set. It focuses solely on the verification and validation studies (test sets) comparing ImagenSPECT™ 3.0 against predicate devices/methods.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set or its sample size, there is no information on how ground truth for a training set was established.
§ 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.