(250 days)
The Cardio7 electrocardiograph is one of the tools that clinicians can use to evaluate and diagnose patient cardiac function. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
Cardio7 is an EKG monitoring system that provides standard EKG and (optional) pulmonary diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG and pulmonary monitoring, data analysis and data management functions.
The provided document is a 510(k) premarket notification for the Bionet Cardio7 electrocardiograph. It claims substantial equivalence to a predicate device (Bionet CardioXP, K102767) rather than providing a detailed performance study with established acceptance criteria and results.
Therefore, the document explicitly states: "Because Cardio7 complies with the EC11 standard, assessment of performance data is not necessary to determine of Substantial Equivalence for this type of device."
This means that a specific study demonstrating compliance against acceptance criteria, as typically seen for devices requiring clinical evidence for efficacy or safety, was not included or deemed necessary for this 510(k) submission. Instead, compliance with the EC11 standard for electrocardiographs was deemed sufficient to establish substantial equivalence to the predicate device.
Given this, I cannot fill out all the requested information as it is not present in the provided text.
Here's what can be extracted based on the document's content:
1. A table of acceptance criteria and the reported device performance:
Since the document states performance data assessment was not necessary due to EC11 standard compliance, there is no explicit table of acceptance criteria or reported device performance against those criteria. The comparison table (Table 1) focuses on features and specifications, not performance outcomes against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No specific test set or performance study is detailed.
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):
Not applicable. No specific test set or ground truth establishment is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No specific test set or adjudication method is detailed.
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:
Not applicable. This device is an electrocardiograph with an "interpretive algorithm" for analysis, not an AI-assisted diagnostic tool that augments human readers in a comparative effectiveness study. The 510(k) does not mention such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device has a "12-lead ECG interpretive algorithm [that] provides a computer-generated analysis of potential patient cardiac abnormalities". However, the document explicitly states this analysis "must be confirmed by a physician with other relevant clinical information." This indicates it's an assistive tool, and no standalone performance study without human confirmation is detailed in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No specific performance study with ground truth is detailed.
8. The sample size for the training set:
Not applicable. No details about algorithm training are provided in this regulatory submission.
9. How the ground truth for the training set was established:
Not applicable. No details about algorithm training are provided.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).