Search Results

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. Patients exercise by bicvcle, 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 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. HyperQ™ 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 an electrocardiogram (ECG). The device analyzes and records the high frequency components of the QRS complex of standard ECG.

The provided document, K072389, is a 510(k) summary for the HyperQ™ System. It outlines the device's intended use and a comparison to a predicate device, but it does not contain information regarding detailed acceptance criteria, specific study designs (like sample sizes, data provenance, ground truth establishment, or expert qualifications), or performance metrics (sensitivity, specificity, accuracy, etc.) typically found in a clinical study report.

The document focuses on demonstrating substantial equivalence to a predicate device (HyperQ™ System K070624) based on technological characteristics and intended use. It states: "The primary difference is that the modified device provides a reformatted graphic interface unit (GIU) with additional enhancements, features, and user selectable options. Based upon the validation results, BSP believes these differences do not raise additional safety of efficacy concerns."

The only mention of performance testing is related to the ST segment algorithm: "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." However, no details about this testing (e.g., acceptance criteria, results, study design, sample size, or ground truth) are provided.

Therefore, many of the requested details cannot be extracted from this specific 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document. It mentions "a database is used as a tool for performance testing" for the ST segment algorithm, but no details about this database are provided.

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)

• Number of Experts: Not specified in the document.
• Qualifications of Experts: Not specified in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified in the document.

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 Comparative Effectiveness Study: No evidence of an MRMC study is mentioned. The document primarily focuses on technological equivalence to a predicate device, not on human-AI comparative effectiveness.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance Study: The document indirectly suggests some form of standalone testing for the ST segment algorithm, stating it "has been tested for accuracy of the ST segment data," and for the HyperQ™ stress test where it analyzes HF-QRS changes. However, no specific results or a clear "standalone performance study" section with metrics are provided. The device itself is described as a "compact monitor for measuring, processing, storing, and displaying information." The "HyperQ™ Software is intended to be used as an aid to stress ECG test," implying it complements rather than replaces physician interpretation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not specified in the document for any testing.

8. The sample size for the training set

• Sample Size for Training Set: Not specified in the document.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not specified in the document.

Ask a specific question about this device