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The MAC 5 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 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.
The device 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 cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow.
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 is a 510(k) summary for the GE MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System. It focuses on demonstrating substantial equivalence to a predicate device (MAC 7 Resting ECG Analysis System) and a reference device (ELI 380 - 12 Lead Resting ECG). The documentation does not contain specific acceptance criteria and performance data for the device's diagnostic capabilities, nor does it detail a study proving the device meets particular acceptance criteria related to its interpretive analysis.

The document primarily focuses on explaining that the device is substantially equivalent to existing devices based on technical specifications, intended use, indications for use, and a comparison of features. It explicitly states, "The subject of this premarket submission, MAC 5 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I describe a study that proves the device meets those criteria, as such information related to diagnostic performance is not present.

However, I can extract information related to the device's characteristics and the comparison to predicate/reference devices:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy for disease detection) for the interpretive ECG analysis, nor does it report the device's performance against such criteria. The "performance" discussed is in terms of feature functionality and technical specifications being "substantially equivalent" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission states that clinical studies were not required to support substantial equivalence.

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)

This information is not provided. Since no clinical studies were deemed necessary, there is no mention of a test set with expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

No MRMC comparative effectiveness study was mentioned. The submission states that clinical studies were not required. The device provides "interpretation of the data for consideration by a physician" and "is not intended as a sole means of diagnosis," indicating it's an assistive tool, but no study validating its impact on human reader performance is presented here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone performance study of the interpretive algorithm (12SLTM analysis algorithm v24) is detailed in this document. The focus is on the substantial equivalence of the overall system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided.

8. The sample size for the training set

The document does not provide information about the training set for the 12SLTM analysis algorithm. It only mentions that the proposed device uses "12SLTM analysis algorithm (v24)" (which is an updated version of the algorithm used in the predicate device, v23.1). It states "No changes to the interpretive statements of the 12SLTM analysis algorithm (v24) under K141963 and compared to the predicate device. The changes introduced with the 12SLTM (v24) do not impact the ECG analysis (measurement or accuracy) of the algorithm." This suggests the algorithm itself has been previously validated, but details are not in this document.

9. How the ground truth for the training set was established

This information is not provided in this document.

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