(123 days)
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device.
• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
The MAC 7 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.
The MAC 7 can capture 3, 6 or 12 lead electrocardiograms, provide interpretive analysis, and print reports.
The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with the cardiology information systems such as the GEHC MUSE®
The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.
The provided text doesn't contain specific acceptance criteria or details about a study proving the device meets those criteria. The 510(k) summary indicates that no clinical studies were required to support substantial equivalence for the MAC 7 Resting ECG Analysis System.
However, it does state that the device underwent non-clinical tests to demonstrate compliance with applicable voluntary standards and quality system regulations.
Therefore, for your request, the following information is not available in the provided document:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI vs without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document explicitly states:
"Summary of Clinical Tests: The subject of this premarket submission, MAC 7 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence."
This indicates that the FDA's clearance was based on non-clinical testing and substantial equivalence to a predicate device (MAC VU360 Resting ECG Analysis System K173830), rather than on a clinical study with specific acceptance criteria for diagnostic performance. The substantial equivalence argument relies on the new device employing "the same fundamental scientific technology, basic design, construction, materials, energy source, control mechanism, operating principles as the predicate device MAC VU360".
§ 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).