(274 days)
The MAC VU360 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 overread as well as consideration of all other relevant patient data.
-The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.
The MAC VU360 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The MAC VU360 can capture 3, 6, 12, or 15 lead electrocardiograms, provide interpretive analysis, and print reports. The MAC VU360 is indicated for use on adult and pediatric (birth through 21 years of age) populations. 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® system to participate in a complete electrocardiology workflow. The device can also optionally display data from external systems which provide web or Citrix content. The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via a wheeled trolley. The MAC VU360 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the MAC VU360 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size. The MAC VU360 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
The provided text does not contain detailed information about a study proving the device meets specific acceptance criteria with a table of performance metrics, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
The document is a 510(k) summary for the MAC VU360 Resting ECG Analysis System. It primarily focuses on demonstrating substantial equivalence to a predicate device (ELI 380 Resting Electrocardiograph), rather than presenting a performance study with detailed acceptance criteria and results.
Here's what can be extracted and what is not available based on the provided text:
Acceptance Criteria and Device Performance:
The document states "The subject of this premarket submission, MAC VU360 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." This implies that the acceptance criteria for this submission were primarily based on technological similarity to the predicate device and compliance with voluntary standards, rather than a clinical performance study with defined quantitative metrics.
Therefore, a table of acceptance criteria and reported device performance, as requested, cannot be generated from the provided text because such a study was not deemed necessary for substantial equivalence in this context.
Other Information:
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Sample sizes used for the test set and the data provenance: Not applicable, as no dedicated clinical performance test set is described. The device's performance is asserted through its use of the 12SL Algorithm, which is referenced as being used by a reference device (MAC 5500 HD), implying its prior validation. Data provenance is not specified beyond "adult and pediatric (birth through 21 years of age) populations" for intended use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a specific test set is described for performance evaluation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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. The device provides "interpretation of the data for consideration by a physician" and states that "The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data." This suggests a human-in-the-loop use case, but no MRMC study is detailed to quantify improvements.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data." and "It is not intended as a sole means of diagnosis." This indicates it's designed for human-in-the-loop, and a standalone performance study is not described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study requiring ground truth is detailed. The device relies on the established 12SL Algorithm.
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The sample size for the training set: Not applicable. The document states the device "utilizes the 12SL Algorithm," implying that the algorithm's training (if any was needed) was done previously and is not part of this submission's new data.
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How the ground truth for the training set was established: Not applicable, as no specific training set or its ground truth establishment is described for this submission. The 12SL Algorithm is a pre-existing component/technology.
§ 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).