Search Results

The MAC 800 is a portable ECG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.

The MAC 800 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 mode and (2) Arrhythmia mode.

The basic systems shall print 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.

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 800 is provided to the customer for the convenience of automatic documentation.

The MAC 800 is used under the direct supervision of a licensed healthcare practitioner.

Contraindications:

The MAC 800 is not designed to provide alarms for arrhythmia detection.

The device is not suitable for intra cardiac application.

It is not intended for use:

• As a vital signs physiological monitor; or
• For use during patient transport.

The MAC 800 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. The MAC 800 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. 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.

The MAC 800 delivers multiple leads of ECG on full-size reports and includes an SMS/text message telephone keypad for patient demographics and other data entry with T9 input method, 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 can print the resting ECG report via the external laser printer. The device will have optional internal memory and removable storage to store resting ECG records. The device also can export the resting ECG record to PDF file on SD card as an optional function. An optional barcode reader and magnetic card scanner to enter patient information is available. The MAC 800 can be used as a portable unit.

The provided 510(k) summary for the GE Healthcare MAC 800 Resting ECG Analysis System does not contain acceptance criteria or a study proving that the device meets such criteria.

Instead, the submission states:

• "The subject of this premarket submission, MAC 800 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." (Page 3)
• "GE Healthcare considers the MAC 800 Resting ECG Analysis System to be as safe, as effective, and performance is substantially equivalent to the predicate device." (Page 3)

The document focuses on demonstrating substantial equivalence to a predicate device (K081437, MAC 1600 ECG Analysis System) through non-clinical testing and similarity in technology, rather than presenting a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information, as it is not present in the given text.

If this were a different kind of submission (e.g., a De Novo application or a submission for a novel device), it would typically include a detailed clinical study plan, acceptance criteria, and performance results. However, for a 510(k) submission asserting substantial equivalence, especially for a device type like an electrocardiograph, demonstrating equivalence to an already legally marketed device often suffices without new clinical studies.

Ask a specific question about this device

The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk stratification and prediction of sudden cardiac death. The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations. The Heart Rate Turbulence Analysis Program is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.

The Heart Rate Turbulence Analysis Program is a software algorithm that runs in GE Medical Systems Information Technologies electrocardiographic equipment.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the requested metrics. The document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims.

However, based on the limited information available in the "Test Summary" and "Conclusion" sections, here's what can be extracted and inferred, along with what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text. The term "measurements" is used, implying some testing, but the number of patient records or cases is not mentioned.
• Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not specified. The document does not describe the establishment of a ground truth or the involvement of experts for this purpose in the context of the device's performance validation. The device "only provides measurements, not interpretations," suggesting the ground truth would relate to the accuracy of these measurements rather than diagnostic outcomes.

4. Adjudication Method for the Test Set

• Not specified. Without information on experts or ground truth establishment for the test set, an adjudication method cannot be determined.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done according to the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device based on functional technology and internal quality assurance measures, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, implicitly. The "Test Summary" and "Conclusion" indicate that the algorithm's performance was evaluated in isolation ("The Heart Rate Turbulence Analysis Program... complies with the voluntary standards," "The results of these measurements demonstrated that the Heart Rate Turbulence Analysis Program is... effective..."), separate from human interpretation. The statement "The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations" directly supports this, as its function is to provide raw data for a human to interpret.

7. The Type of Ground Truth Used

• Not explicitly stated, but inferred to be based on physical signal processing accuracy. Given the device's function is to "analyze ECG signals" and "provide measurements of Heart Rate Turbulence," the ground truth likely relates to the accurate calculation of these measurements from the raw ECG signals, possibly against established mathematical models or manually derived gold standard measurements from a subset of data. It is not based on "expert consensus, pathology, or outcomes data" in the conventional sense for diagnostic devices, as the device does not make a diagnosis.

8. The Sample Size for the Training Set

• Not specified. The document does not mention a training set or the process of machine learning model development.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as no training set or machine learning model development is described. The technology is described as employing "the same functional technology as the predicate device for calculating variations of heart rate (RR) intervals," suggesting a rule-based or algorithmic approach rather than a data-driven machine learning model requiring a large labeled training set.

Ask a specific question about this device