(122 days)
This software is intended to be used for the visualization of non-reversible perfusion defects (hypo/hyper dense areas) in patients with angina or with a previous myocardial infarct. Included software tools may aid a trained user in monitoring the disease state and treatment over time. This software provides maps and the values used to generate the maps. The information provided is intended to be qualitative in nature and when used by a qualified physician may aid in the identification of myocardial enhancement defects and the follow up of such findings.
This device processes ECG-gated contrast enhanced cardiac scan data using MPR generated images according to the cardiac axis. The software generates polar maps, perfusion index (PI) map and Transmural Perfusion Ration (TPR) maps based upon the measured CT values of the tissue within the specified region of interest. The software displays the values associated with the generation of the Perfusion Index and TPR Maps. Pl is the ratio of the Mean Myocardial CT value to the LV blood pool CT value. TPR is provided as a ratio per sector of the Endocardial CT value to the mean Epicardial CT value.
The provided 510(k) summary for MyoPerfusion, CSMP-001A, is a short document outlining the device's purpose and its substantial equivalence to predicate devices. While it mentions "performance testing," it does not provide detailed acceptance criteria or results from a specific clinical study that proves the device meets those criteria.
The information primarily focuses on regulatory compliance, device description, and comparison to predicate devices, rather than a detailed performance study report.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) for the device's performance in identifying perfusion defects. Similarly, it does not provide a table of reported device performance metrics against such criteria. The "Testing" section broadly states that "performance testing conducted through bench testing" demonstrates that "design specifications established for the device have been met and that the perfusion map calculation and auto segmentation used by the software will appropriately display visualization tools." This is a general statement of compliance, not a detailed performance report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document mentions "bench testing" but does not detail the nature or origin of any data used.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. Since details on the test set itself are absent, the adjudication method is also 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
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The filing describes the device as providing "visualization tools" and "maps and values" to aid a "trained user" and "qualified physician," suggesting it's intended as an aid to diagnosis, but there is no study assessing its impact on human reader performance.
- Effect Size of Improvement: Not applicable, as no MRMC study is reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not explicitly indicated or detailed. The document states that the software "appropriately display[s] visualization tools," and that it "provides maps and the values used to generate the maps." This implies the algorithm's functional performance in generating these outputs was assessed, but not an independent diagnostic performance of the algorithm itself without human interpretation. The "Indications for Use" continuously emphasizes use by a "trained user" and "qualified physician," and states the information is "qualitative in nature," which further suggests it's not a standalone diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. The device description notes it "processes ECG-gated contrast enhanced cardiac scan data," but doesn't mention a training set in the context of machine learning or AI. Given the date of the 510(k) (2013), and the nature of the description ("perfusion map calculation and auto segmentation"), it's possible the software relies on more deterministic algorithms rather than sophisticated AI requiring large training sets in the modern sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not specified.
Summary of Study Information:
The 510(k) summary provides minimal information regarding specific performance studies or acceptance criteria. It focuses on demonstrating substantial equivalence to predicate devices based on intended use and similarity in the manner of performance (i.e., post-processing software for visualizing cardiovascular anatomy and pathology). The "Testing" section vaguely mentions "hazard analysis, verification/validation and performance testing conducted through bench testing" to ensure "design specifications have been met" and that the software "will appropriately display visualization tools." However, it does not offer the granular detail requested for acceptance criteria, sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone performance).
§ 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.