(90 days)
SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.
SnapShot Freeze 2 (SSF 2) is a post processing software, which can be delivered on general purpose computing platforms. SnapShot Freeze 2 is an automated motion correction algorithm designed for use with gated cardiac acquisitions from GE CT scanners to reduce cardiac induced motion artifacts in the whole heart. It is based on the same fundamental algorithm as the predicate product commercially marketed under the name CardIQ Xpress 2.0 with SnapShot Freeze Option (K120910, AKA SSF 1). Same as its predicate device the SSF 2 algorithm works on multi-phase, gated cardiac CT DICOM compatible image data and produces a new image series in which motion artifact is reduced.
The provided text does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in a table. Instead, it describes internal validation and testing to support the product's substantial equivalence to a predicate device.
However, based on the information provided, here's an attempt to extract relevant details and structure them according to your request, with disclaimers that much of the quantitative information you're asking for (like specific acceptance criteria values and reported performance against them) is not present in the given document.
Device Name: SnapShot Freeze 2
Intended Use: Motion correction of gated cardiac image series.
Indications for Use: Designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.
Overview of Device Performance and Acceptance (as inferred from the document):
The document describes engineering bench testing and a clinical assessment to demonstrate that SnapShot Freeze 2 is "as safe and effective, and performs in a substantially equivalent manner to the predicate device CardIQ Xpress 2.0 with SnapShot Freeze Option." The main improvement of SnapShot Freeze 2 is its ability to extend motion correction to the "whole heart" beyond just coronary vessels.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a clear table of predefined acceptance criteria with corresponding numerical performance results. However, it mentions qualitative performance improvements and claims of "effective temporal resolution" based on phantom testing.
| Feature / Criterion (Inferred from text) | Acceptance Criteria (Not explicitly stated with thresholds) | Reported Device Performance (as stated or inferred) |
|---|---|---|
| Motion Correction (Coronary Vessels) | Expected to be equivalent to predicate. | "6x improvement in reducing blurring artifacts of the coronary arteries due to cardiac motion." (Inherited from predicate, reiterated for SSF2) |
| Motion Correction (Whole Heart) | Demonstrate ability to perform whole heart motion correction. | "Yes, enhancement to the algorithm demonstrates whole heart motion correction." |
| Effective Temporal Resolution | Maintain or improve upon predicate's resolution. | "29 ms for 0.35 sec/rot gantry speed." (Inherited from predicate). |
| "24 ms for 0.28 sec/rot gantry." (New for SSF2 at faster gantry speed). | ||
| Diagnostic Capability of Motion Corrected Images | Images should demonstrate diagnostic utility. | "The assessment demonstrated the diagnostic capability of the motion corrected images by SSF 2." (Qualitative statement) |
| No New Risks/Hazards | Device should not introduce new risks. | "SnapShot Freeze 2 does not introduce any new risks/hazards, warnings, or limitations." |
| "No new hazards were identified, and no unexpected test results were obtained." | ||
| Substantial Equivalence | Device must be substantially equivalent to predicate. | "GE Medical Systems believes that the SnapShot Freeze 2 is as safe and effective, and performs in a substantially equivalent manner to the predicate device CardIQ Xpress 2.0 with SnapShot Freeze Option." |
2. Sample Size and Data Provenance for Test Set:
- Sample Size for Clinical Assessment: A "representative clinical sample image set of 60 CT cardiac cases."
- Data Provenance: The document states this data is "representative of routine clinical imaging from a cardiac acquisition perspective," but "intentionally includes data from subjects with elevated heart rates or those with heart rate variability which represent more challenging cases." It does not specify the country of origin, nor explicitly state if it was retrospective or prospective, but the phrasing "representative clinical sample image set" and "routine clinical imaging" suggests it was likely a retrospective collection of existing patient data.
3. Number of Experts and Qualifications for Ground Truth for Test Set:
- Number of Experts: Three board certified radiologists.
- Qualifications: "Board certified radiologists." No further details on years of experience are provided.
4. Adjudication Method for the Test Set:
- The document states, "A representative clinical sample image set of 60 CT cardiac cases... were assessed by three board certified radiologists using 5-point Likert scale."
- It does not specify an adjudication method (e.g., 2+1, 3+1 consensus, or independent reading). It only states they "assessed" the cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study demonstrating how human readers improve with AI vs. without AI assistance is explicitly described. The clinical assessment was to demonstrate the "diagnostic capability of the motion corrected images by SSF 2," not a direct comparison of human reader performance with and without the tool.
6. Standalone (Algorithm Only) Performance:
- The document implies that the effective temporal resolution metrics (29 ms, 24 ms) derived from "mechanical and mathematical cardiac phantom testing" represent the standalone performance of the algorithm in terms of motion correction capability, independent of human interpretation.
- The clinical assessment of "diagnostic capability" also evaluates the output of the algorithm, suggesting an evaluation of its quality for diagnostic purposes.
7. Type of Ground Truth Used for the Test Set:
- The "ground truth" for the clinical assessment appears to be the expert consensus/assessment of the three board-certified radiologists using a 5-point Likert scale to determine the "diagnostic capability" of the motion-corrected images. No mention of pathology or outcomes data as direct ground truth for image quality/diagnostic utility is made for the 60 clinical cases.
8. Sample Size for the Training Set:
- The document does not specify a sample size for the training set. It describes the algorithm's fundamental similarity to its predicate (SSF1) and states that SSF2 "extends the motion correction capability to the whole heart." This suggests the core algorithm was already established, and the "enhancement" for whole-heart motion correction might have involved further development or refinement without explicitly detailing a new, distinct "training set" in this submission summary.
9. How Ground Truth for Training Set was Established:
- The document does not describe how the ground truth for any potential training set was established. Given that the algorithm is based on and an extension of a predicate device, it's plausible that the underlying algorithm was developed and validated earlier, and the current submission focuses on the safety and effectiveness of the extended capability.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.