(30 days)
The MAC 5500 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The MAC 5500 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 MAC 5500 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and the patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment. The MAC 5500 can deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 system acquires ECG data using the CAM14 patient data acquisition module. By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5500 delivers 12 or 15 lead ECG's on full-size reports. The MAC 5500 incorporates a alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, an integrated thermal writer and removable data storage. Additionally, the MAC 5500 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.
The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for ground truth. It largely focuses on regulatory classification and the device's intended use. No information is available regarding MRMC studies or standalone algorithm performance.
However, based on the Conclusion statement on page 2 of 7:
Conclusion: The results of these measurements demonstrated that the MAC 5500 ECG Analysis System is as safe, as effective, and performs as well as the predicate devices.
This implies that the acceptance criteria are implicitly met if the device performs "as well as the predicate devices" in terms of safety and effectiveness.
Here's an attempt to structure the answer based on the limited information, with many fields marked as 'Not provided in the text'.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| As safe as predicate devices | Demonstrated to be as safe as predicate devices (Implied) |
| As effective as predicate devices | Demonstrated to be as effective as predicate devices (Implied) |
| Performs as well as predicate devices (functional equivalency) | Performs as well as predicate devices (Implied) |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not provided in the text.
- Data provenance: Not provided in the text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not provided in the text.
- Qualifications of experts: Not provided in the text.
4. Adjudication method for the test set
- Adjudication method: Not provided in the text.
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
- MRMC study: Not provided in the text. The device is described as an ECG analysis system, but no details of a human-in-the-loop study are present.
- Effect size: Not applicable, as no MRMC study details are provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: The conclusion states "The results of these measurements demonstrated that the MAC 5500 ECG Analysis System is as safe, as effective, and performs as well as the predicate devices." This suggests that some form of performance evaluation was conducted for the device's algorithms, likely in a standalone capacity, to establish its equivalency to predicate devices. However, no specific details of such a study are provided.
7. The type of ground truth used
- Type of ground truth: Not explicitly stated. Given it's an ECG analysis system, the ground truth would likely involve expert-interpreted ECGs or potentially correlated clinical outcomes, but this is speculative.
8. The sample size for the training set
- Training set sample size: Not provided in the text.
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Not provided in the text.
§ 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).