(20 days)
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, 12 lead 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 5000 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 5000 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 patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment. The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead 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 5000 system acquires ECG data using a modular patient data acquisition device called the CAM14 (K991735). By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5000 delivers 12 or 15 lead ECG's on full-size reports with alphanumeric keyboard for patient demographic and other data entry, a full-size VGA graphics and waveform display, integrated thermal writer and removable data storage. Additionally, the MAC 5000 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 document K033492 is a 510(k) summary for the MAC 5000 ECG Analysis System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The submission states that the "results of these measurements demonstrate that the MAC 5000 is as safe, effective, and performs as well as the predicate device," but it does not provide the specific measurements or the acceptance criteria used for that determination.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not Available. The document does not provide a table of acceptance criteria or specific reported device performance metrics in numerical form. It states that the device "performs as well as the predicate device" but does not quantify this performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Available. The document mentions "Software and hardware testing," "Safety testing," "Environmental testing," and "Final system validation" but does not disclose the sample size of any test sets (e.g., number of ECGs or patients) or the provenance of the data used for these tests.
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)
Not Available. The document does not describe how ground truth was established for any testing, nor does it mention the involvement or qualifications of experts for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Available. The document does not mention any adjudication method for a test set.
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
Not Available. The document does not describe an MRMC study or any study involving human readers with or without AI assistance. The device is an ECG analysis system, which typically provides automated interpretations, and the focus of the submission is on its equivalence to a prior automated system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Likely Yes, but details are not provided. The submission focuses on the "ECG Analysis System" and specifically mentions that "All algorithms have been previously cleared and include: ECG Analysis Program 12SL (K002209) Phi Res Algorithm (K972199)". This implies that the algorithms function in a standalone capacity to provide interpretations. However, the document does not present separate standalone performance metrics or a study specifically detailing this. The "Test Summary" mentions "Software and hardware testing" and "Final system validation," which would implicitly include standalone algorithm performance, but no results are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Available. The document does not specify the type of ground truth used for any testing or validation.
8. The sample size for the training set
Not Available. The document does not provide any information about the training set size for the ECG analysis algorithms. It mentions that previously cleared algorithms (12SL and Phi Res) are utilized, but details about their training are not in this submission.
9. How the ground truth for the training set was established
Not Available. Similar to the above, the document references previously cleared algorithms but does not disclose how their training set ground truth was established.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.