(83 days)
CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office.
CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.
- Patient Population: Male/Female, Adults .
- Environment of Use: Hospital and Clinic .
- Prescription Device by a Physician ●
CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office.
CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.
The provided document describes a 510(k) premarket notification for the CardioView 32 Review Module, an ECG interpretive software. The focus of the submission is to demonstrate substantial equivalence to a previously cleared predicate device, the CardioView 3000.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for diagnostic accuracy (e.g., sensitivity, specificity for specific ECG abnormalities) for the device. Instead, the "Performance Standards" section indicates compliance with a general standard:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| AAMI EC11-1991 Requirements (Diagnostic Electrocardiographic Devices) | Meets AAMI EC11-1991 Requirements |
The submission relies on demonstrating that the modified CardioView 32 Review Module is as safe and effective as the unmodified CardioView 3000 predicate device, largely by showing that the fundamental interpretation algorithm (Cardionics Algorithm) remains the same, and that other modifications are related to software functionality, display, and operating system compatibility, rather than core diagnostic performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any specific information regarding a test set (e.g., ECG recordings used for validation), its sample size, or the provenance of the data (e.g., country of origin, retrospective or prospective). The "Summary of Performance Testing" only states that the device "has been tested or found otherwise to comply with applicable sections of the following standards: AAMI EC11-1991 (R/2007)." This suggests compliance through technical evaluation against the standard's requirements rather than a clinical performance study using a medical dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Since no specific test set or clinical performance study is described, there is no information about the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
Again, given the absence of a described test set or clinical performance study, there is no information regarding an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technical specifications and adherence to a general standard, rather than a clinical comparison of human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that the CardioView 32 Review Module "provides interpretive statements for which the physician renders his/her own medical opinion." This indicates that the software is not intended for standalone diagnostic use; it produces interpretations that are reviewed by a physician. While the underlying "Cardionics Algorithm" performs the primary interpretation, the submission does not detail a standalone performance study where the algorithm's output alone was assessed against a ground truth without human review. The claim is that the algorithm itself is the same as the predicate.
7. The Type of Ground Truth Used
As there is no detailed performance study described, there is no explicit mention of the type of ground truth used. If the predicate device's algorithm was validated, it would likely have been against expert consensus or possibly outcomes data, but this submission does not provide those details for the modified device.
8. The Sample Size for the Training Set
The document does not provide any information about the training set sample size. The "Cardionics Algorithm" is a pre-existing component, and no details regarding its development or training are included in this 510(k) summary.
9. How the Ground Truth for the Training Set was Established
Similar to the above, the document does not provide any information on how the ground truth for the algorithm's training set was established, as the algorithm itself pre-dates this submission and is considered a "Same" component as the predicate device.
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