(293 days)
CARDIOVIEW™ 3000 interpretive software is a Windows-based program intended to interpret electrocardiograms. CARDIOVIEW™ 3000 interpretive software receives, displays and stores a single or standard 12-lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.
The proposed device is computer software which receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. Using a complex mathematical analysis of a 12 Lead ECG, the software can also provide an interpretation of the ECG recording.
The provided text describes the CARDIOVIEW™ ECG Interpretive Software, K974352. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study comparing the device to acceptance criteria, sample sizes for test or training sets, expert qualifications, or adjudication methods.
The document is a 510(k) summary and an FDA clearance letter. It states that nonclinical testing was performed to compare the proposed device to a predicate device (MAX 1 Exercise Testing System), and concluded that the proposed device is "substantially equivalent" to the predicate device. Substantial equivalence is the basis for 510(k) clearances, implying that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested details are not present in this document.
Here's a summary of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Nonclinical testing showed the proposed device to be substantially equivalent to the predicate device (MAX 1 Exercise Testing System). |
Missing Information: Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets for ECG interpretation) are not detailed in this document.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not specify the sample size of the test set used for nonclinical testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: The document does not mention the number or qualifications of experts used to establish ground truth for any testing.
4. Adjudication method for the test set
Missing Information: No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Missing Information: The document does not describe a multi-reader, multi-case comparative effectiveness study involving human readers with and without AI assistance. The nonclinical testing mentioned was a comparison between the proposed device and a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Answer: Yes, the nonclinical testing section states: "Testing showed the proposed device to be substantially equivalent to the predicate device. Both devices use proprietary algorithms to receive, store, analyze and interpret the ECG signal." This implies a standalone evaluation of the algorithm's performance against the predicate device's algorithm.
7. The type of ground truth used
Missing Information: The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). In the context of ECG interpretation, ground truth is typically established by expert cardiologists reviewing the ECGs and, sometimes, correlating with clinical data or more definitive diagnostic tests.
8. The sample size for the training set
Missing Information: The document does not provide any details about a training set or its size.
9. How the ground truth for the training set was established
Missing Information: As no training set details are provided, the method for establishing its ground truth is also not mentioned.
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