(31 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: Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. 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 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 waveforms are compared to the resting ECG records. 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. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential. 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 acuracy 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. HyperQ™: The HyperQ™ Software is intended to be used as an aid to the ECG stress 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 an electrocardiogram (ECG). The device analyzes and records the high frequency components of the QRS complex of standard ECG.
The provided text is a 510(k) summary for the HyperQ™ System, which is an ECG monitoring device. It describes the device's intended use and compares it to a predicate device, but it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Missing. The document states 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" and similar for "validation results" of enhancements, but it does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported performance values for these metrics.
2. Sample Size for the Test Set and Data Provenance
Missing specific details. The document mentions "a database is used as a tool for performance testing" for the ST segment algorithm and that "validation results" were obtained for the modified device. However, it does not specify the sample size of this database or the nature of the data (e.g., number of patients, number of ECGs, country of origin, retrospective or prospective). Given the manufacturer is based in Israel, it's possible the data originated there, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Missing. The document indicates that "The significance of the ST segment changes must be determined by a physician" and "The significance of the HF-QRS changes must be determined by a physician." This implies physician involvement in interpreting results, which could be related to ground truth. However, it does not specify the number of experts used, their qualifications, or their role in establishing ground truth for the test set.
4. Adjudication Method for the Test Set
Missing. There is no information provided about any adjudication methods used (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating the device's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes the device itself and its equivalence to a predicate device. It does not mention any MRMC study or comparative effectiveness study involving human readers with or without AI assistance. The device is presented as an aid to the stress ECG test, assisting physicians, but not in the context of comparative performance against human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document heavily implies a standalone algorithm's performance was evaluated, as it states: "The ST segment algorithm has been tested for accuracy of the ST segment data..." and "changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values." These statements suggest the algorithm generates data and makes comparisons autonomously. However, no specific "standalone study" with detailed results is described. The context is that the output of the algorithm needs to be interpreted by a physician.
7. The Type of Ground Truth Used
The document states, "The significance of the ST segment changes must be determined by a physician" and similarly for HF-QRS changes. This suggests that expert physician interpretation or diagnosis serves as the ultimate ground truth for the clinical significance of the ECG changes detected by the device. It's not explicitly stated whether this ground truth was derived from pathology, outcomes data, or only expert consensus on ECG readings.
8. The Sample Size for the Training Set
Missing. The document does not provide any information about a training set or its sample size. This is typical for a 510(k) for a device like this, which focuses on substantial equivalence rather than a de novo marketing application requiring detailed algorithm development and validation data.
9. How the Ground Truth for the Training Set Was Established
Missing. As no training set information is provided, there is no mention of how its ground truth was established.
In summary, the provided text serves as a regulatory submission focused on substantial equivalence to a predicate device, highlighting its intended use and technological characteristics rather than providing a detailed scientific study report with specific performance metrics and validation methodologies.
§ 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).