(132 days)
ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases:
- Patients with suspected cardiac abnormalities
- Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired.
Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in both ECG waveform and, in the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as Root Mean Square (RMS) values, are compared to the resting values.
ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.
The HyperQ™ Software is intended to be used as an aid to stress ECG test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.
The HyperQ™ System is a compact monitor for measuring, processing, storing, and displaying information derived from the following physiological measurements:
- Electrocardiogram (ECG). A twelve lead ECG is acquired and a waveform can be displayed real-time on the LCD screen, recorded or printed. The design of the ECG function is derived directly from the predicate device, the PC ECG 1200 device.
- Detection, analyzing and recording of the high frequency components of the QRS complex of standard ECG signals.
The provided text is a 510(k) summary for the HyperQ™ System, which is a physiological patient monitor primarily for ECG and stress testing, including analysis of high-frequency components of the QRS complex (HF-QRS). The document does not contain a dedicated section detailing specific acceptance criteria and a study proving the device meets them with quantitative performance metrics.
However, based on the information provided, we can infer some aspects related to its performance claim, which is primarily substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) nor does it present a table of reported device performance against such criteria. The primary performance claim is related to substantial equivalence to a predicate device and compliance with various voluntary and federal standards.
The document states:
- "The HyperQ™ System is substantially equivalent to the PC ECG 1200 device (NORAV MEDICAL LTD.) cleared under K000404 in terms of intended use, technological characteristics, performance and user interface."
- "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." (No specific accuracy values are provided).
- Compliance with various standards: U.S. Federal Performance Standard set forth in 21 CFR 898 for electrode lead wires and Patient Cables; IEC-601-1:1988 and amendments, IEC 60601-1-2:2001, IEC 60601-2-27:1994, IEC60601-2-25:1999 and amendment, IEC 60601-1-4:1996, EC53:1995, EC38:1998 and EC11:1991.
Since no specific performance metrics like sensitivity, specificity, or accuracy are provided for the HyperQ™ System itself, a performance table cannot be constructed with quantitative values for an "AI" component. The document focuses on the functional equivalence and safety aspects relative to the predicate device and established standards.
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 mentions: "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing."
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
For the HyperQ™ software module, it states: "The HyperQ™ System includes a new off-line software module that does not raise new issues of safety or effectiveness based on previous pre-clinical and clinical studies and software validation." This implies some form of testing or validation was performed, but details about the test set are missing.
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 specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified.
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 mentioned or implied. The document states the HyperQ™ software is "intended to be used as an aid to stress ECG test" and that "The significance of the HF-QRS changes must be determined by a physician." This suggests a human-in-the-loop scenario, but no comparative effectiveness study with or without the AI aid is described, nor is an effect size reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document mentions that "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing." This implies a standalone evaluation of the algorithm's accuracy, but no specific results are provided. The broader HyperQ™ System, including the HF-QRS analysis, is framed as an "aid" to a physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the ST segment algorithm, it states it was "tested for accuracy of the ST segment data." This implies the existence of a reference standard (ground truth) for ST segment changes, likely established by expert interpretation or a highly reliable measurement, but the specific method (e.g., expert consensus with explicit criteria) is not detailed.
8. The sample size for the training set:
Not specified.
9. How the ground truth for the training set was established:
Not specified.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).