(61 days)
MedicHeart 1 is a PC-based, stand-alone, non-invasive, image analysis software application intended to assist radiologists and other clinicians in the identification and quantification of coronary calcified plaques in the coronary arteries from CT image data. This quantification allows for evaluation of the progression or regression of calcified plaques in coronary arteries over time.
MedicHeart™ is a software tool designed to assist radiologists and other clinicians in the identification and quantification of coronary artery calcification. The software allows the user to manually select Regions of Interest by a single click or a drawing tool followed by semi-automatic detection. It provides calculation of calcium score using the traditional Agatston method, as well as measurement of the volume and mass of calcified plaques.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the MedicHeart™ Release 1 device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the MedicHeart™ Release 1 device's performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance is reported in terms of achieving this equivalence.
| Acceptance Criteria Category | Specific Criteria (from predicate equivalence) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Device evaluates CT images for identification and quantification of coronary artery calcified plaques, similar to GE SmartScore, Viatronix V3D, and Voxar Calcium Scoring. | "The functional features and the intended use of MedicHeart 1 are substantially equivalent to the predicate devices." |
| Safety | Residual risks are as low as reasonably practicable and acceptable when weighed against benefits. | "A comprehensive hazard analysis was carried out... concluded that any residual risks were as low as reasonably practicable and judged as acceptable..." |
| Overall Performance | Equivalent in performance to existing legally marketed devices (predicates). | "MedicHeart 1 does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Test data are provided to validate the performance of the system and its substantial equivalence to the predicate devices." However, it does not specify the sample size of the test set used.
Regarding data provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish the ground truth for the test set, nor does it detail their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. Therefore, no effect size for human readers' improvement with AI assistance can be determined from this document. The focus is on the device's standalone performance compared to predicates.
6. Standalone Performance Study
Yes, a standalone study was done. The device is described as a "PC-based, stand-alone, non-invasive, image analysis software application." The reported performance focuses on its ability to identify and quantify coronary calcified plaques and its substantial equivalence to predicate devices, without explicitly involving human-in-the-loop performance measurement.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The phrase "identification and quantification of coronary artery calcification" suggests a ground truth related to anatomical presence and extent of calcification, likely established through expert review of imaging data that the device processes.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. In fact, it doesn't mention a "training set" at all, which is common for regulatory submissions where the focus is on validation against an independent test set.
9. How Ground Truth for the Training Set Was Established
Since the document does not mention a training set, it does not describe how its ground truth was established.
§ 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.