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The MAC1600 is a portable ECG acquisition, analysis and recording system. The MAC1600 is intended to acquire, analyze, display and record information from adult and pediatic populations. Pediation is defined as patients between the ages of 0 and 15 years. The MAC1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The basic system shall provide 2 modes of operation: (1) Resting ECG mgnae nd (1) Arrhythmia mode. The basic systems shall print 6 or 12-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. The basic system shall be upgradeable with a third mode of operation: (3) Exercise mode for exercise stressing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional. The arrhythmia detection portion of the MAC 1600 is provided to the customer for the convenience of automatic documentation.

The MAC1600 is used under the direct supervision of a licensed healthcare practitioner.

The MAC 1600 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. MAC1600 is also capable of acquiring 2 additional ECG leads beyond what is needed for classical 12 lead ECG acquisition. The MAC 1600 will provide, in resting ECG mode, ECG quality information using the hookup advisor. The hookup advisor advises users of poor lead quality based on noise measurement. It can be upgraded to provide options such as ECG measurement and interpretation with 12SL as well as a stress testing option for exercise stress testing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is also optional. Multiple QT correction formulas including Bazett, Framingham and Fridericia will be available as a user selectable option. Clinical Trials Data Guard and audit trail options are also available to support electronic record requirements.
The MAC 1600 delivers multiple leads of ECG on full-size reports and includes an alphanumeric keyboard for patient demographics and other data entry, an integrated 7" color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non real time reports. The device will have optional internal memory and removable storage to store resting ECG records. An optional barcode reader to enter patient information is available. The MAC 1600 can be used as a portable unit.

The provided text describes the MAC 1600 ECG Analysis System, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices, outlining the device's technical characteristics, intended use, and regulatory classification. It does not detail specific performance studies with quantitative results against predefined acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.

Here's why each point cannot be addressed:

1. Table of acceptance criteria and reported device performance: This information is not included. The document states that the "technological characteristics of the MAC 1600 have been updated to reflect use of current technology and to incorporate user requested features. Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness." This is a general statement rather than a detailed performance report against specific criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The document primarily focuses on the device's own capabilities and its equivalence to predicate devices.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: The document describes the device's "12-lead ECG measurement and interpretive analysis" as an optional software feature and mentions "arrhythmia detection portion" for automatic documentation, implying standalone algorithmic functions. However, no specific study demonstrating its standalone performance is detailed.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document's conclusion, "This premarket notification submission demonstrates that the MAC 1600 ECG Analysis System is substantially equivalent to the previously cleared devices and differences in technological characteristics do not raise new questions of safety or effectiveness," indicates that the submission relies on the established safety and effectiveness of the predicate devices (CardioSmart ST V1.3 and CASE/Cardiosoft) rather than new, detailed performance studies for the MAC 1600.

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