(214 days)
The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and alternate professional healthcare environments. The system is indicated for use in pediatric and adult patients.
The Matrix Mini ECG Monitor system provides a cardiac monitor which monitors ECG derived heart rate, ECG electrode impedance respiration rate, and specific ECG arrhythmias (including asystole, ventricular tachycardia, and ventricular fibrillation). The Matrix Mini ECG Monitor system consists of a display module, a data acquisition module and an ECG patient cable.
The display module and the data acquisition module are connected together with a USB interface. The data acquisition module is connected to the patient with the ECG patient cable, which is attached to standard ECG electrodes applied to the patient's skin surface.
The display module consists of a tablet computer which provides the graphical display, user interface, data processing, data reporting/review, data communication, alarm, and data storage functions. The data acquisition module provides the patient electrical isolation, interface to ECG skin surface electrodes attached to patient, conversion of analog ECG electrode data to digital data, data processing, and data communication functions. An accessory ECG patient cable is provided to connect the data acquisitions module to standard skin surface ECG electrodes. The accessory ECG patient cables are available in 3 or 5 ECG lead configurations.
The Matrix Mini ECG Monitor provides an ECG heart rate monitor that includes software capable of limited ECG analysis and ECG electrode impedance respiration rate measurement. The Matrix Mini ECG monitor includes the basic functions of the 3 or 5 lead ECG monitoring system hardware standard to a Cardiac Monitor including a Cardiotachometer and rate alarm (product code DRT). The primary predicate device is a cardiac monitor and has a product code of DRT and also provides functions for ECG electrode impedance respiration rate measurement (product code BZQ).
The Matrix Mini ECG Monitor device software can report asystole, ventricular tachycardia and ventricular fibrillation, which may be thought of as arrhythmias, we selected a supplemental predicate device (K120774) with the product code DSI. Both the software device component and hardware components are presented below compared to the currently marketed predicate devices.
The Matrix Mini ECG Monitor uses software to process and display the ECG electrode derived cardiac information to the user. The analog ECG electrode data is acquired and converted to digital data using conventional, well proven, and widely used, electronic digital data acquisition technology. The technology has operational and performance characteristics that comply with IEC 60601-2-27:2011, "Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment". The asystole, ventricular tachycardia and ventricular fibrillation algorithms use conventional software ECG analysis techniques and have been evaluated using ANSI/AAMI EC57:2012 "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms"
The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and professional healthcare environments, in pediatric and adult patients.
1. A table of acceptance criteria and the reported device performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Heart Rate | ||
| Range | 21 to 249 beats/minute (Predicate Standard) | 20 to 300 beats/minute |
| Accuracy | ± 3 beats/minute or ± 3% whichever is greater | ± 3 beats/minute or ± 3% whichever is greater |
| Bandwidth, Normal Mode | 0.5 to 40 Hz (Predicate Standard) | 0.05 to 70 Hz |
| Alarm Ranges (Low) | Heart Rate Low Limits: 21 to 245 beats/minute | Heart Rate Low Limits: 20 to 300 beats/minute |
| Alarm Ranges (High) | Heart Rate High Limits: 25 to 249 beats/minute | Heart Rate High Limits: 20 to 300 beats/minute |
| Samples per second | 180 samples/sec (Predicate Standard) | 250 samples/sec |
| Respiration Rate | ||
| Range | 5 to 100 breaths/minute | 5 to 100 breaths/minute |
| Accuracy | ± 3 breaths/minute | ± 2 breaths/minute |
| Alarm Ranges (Low) | Respiration Low limits: 5 to 100 breaths/minute | Respiration Low limits: 5 to 100 breaths/minute |
| Alarm Ranges (High) | Respiration High limits: 5 to 100 breaths/minute | Respiration High limits: 5 to 100 breaths/minute |
| Arrhythmia Detection | ||
| Types Detected | Asystole, Ventricular tachycardia, Ventricular Fibrillation (Predicate Standard) | Asystole, Ventricular tachycardia, Ventricular Fibrillation |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance. It refers to the use of ANSI/AAMI EC57:2012 "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms" for evaluating the arrhythmia algorithms. This standard typically involves testing against standardized arrhythmia databases, but the specific details of the test set used (e.g., its size, origin, and whether it was retrospective or prospective) are not provided in this submission.
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)
The document does not specify the number of experts or their qualifications for establishing the ground truth of any test sets. The mention of ANSI/AAMI EC57:2012 suggests that ground truth would likely be established based on accepted labeled arrhythmia databases, but no details are given regarding expert involvement in this specific context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the 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
No MRMC comparative effectiveness study was done. The submission states, "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." This indicates that no studies involving human readers, with or without AI assistance, were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, standalone performance testing was conducted. The document states that the asystole, ventricular tachycardia, and ventricular fibrillation algorithms use conventional software ECG analysis techniques and "have been evaluated using ANSI/AAMI EC57:2012 'Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms'". This standard is for evaluating the performance of the algorithms themselves, without human readers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the reference to ANSI/AAMI EC57:2012, the ground truth for the arrhythmia detection algorithms would likely be derived from a standardized arrhythmia database, which typically uses expert-annotated ECG recordings, forming a type of expert consensus ground truth. However, the document does not explicitly state the type of ground truth used for this specific evaluation.
8. The sample size for the training set
The document does not specify the sample size for the training set of the algorithms.
9. How the ground truth for the training set was established
The document does not specify how the ground truth for the training set 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.