Search Results

ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients:
l ) suspected of cardiac abnormalities, or
2) in populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics are desired.
3) OT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacologic therary. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. 4) The PC ECG 1200W System has been tested to measure Heart Rate Variability within 1 millisecond tolcrance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
5) The PC ECG 1200W System has been tested to measure Latc Potential within 1 millisecond tolerance in the time domain, and I microvolt tolerance in voltage. The clinical significance of Heart Rate Variability measures should be determined by a physician.

Stress testing intended use:
Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of a 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 thereby coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the ECG. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol.
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 has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

The PC ECG 1200W System is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The System comprises:

• · PCECG 1200W data acquisition unit
• · PCECG 1200WR RF transceiver
• · USB communications cable
• · Software application
• · Software security lock (dongle) for access to stress testing functions (optional)

The NORAV PC ECG 1200W System is substantially equivalent to the predicate device, Norav's PC ECG 1200 K000404, with the primary difference being the addition of wireless data communication capabilities. The submission primarily focuses on the device's technical specifications and intended use, asserting its safety and reliability based on similarity to the predicate and adherence to recognized standards.

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the device's intended functionality and accuracy in certain measurements, but it does not explicitly state specific pass/fail acceptance criteria in a quantitative manner for most functions. Instead, it makes claims of the device's capabilities and how it has been tested.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document mentions that for the ST segment algorithm, "a database has been used as a tool for performance testing." However, no specific sample size for this database or any other test set is provided.
• Data Provenance: Not specified. It does not mention the country of origin, nor whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is not provided in the document. The document states that "The significance of the ST segment changes must be determined by a physician," but it does not detail how ground truth was established for the performance testing database.

4. Adjudication Method for the Test Set:

• This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• A MRMC comparative effectiveness study was not mentioned or implied in the provided summary. The submission focuses on device equivalence and performance claims rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

• The claims regarding Heart Rate Variability ("within 1 millisecond tolerance") and Late Potential analysis ("within 1 millisecond tolerance in the time domain, and 1 microvolt tolerance in voltage") appear to relate to the standalone performance of the device's algorithms or measurement capabilities.
• Similarly, the statement that "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing" indicates a standalone algorithmic test.
• However, specific metrics or a detailed study of standalone performance results (e.g., sensitivity, specificity, AUC) are not explicitly provided beyond the tolerance statements for HRV and Late Potential.

7. Type of Ground Truth Used:

• For Heart Rate Variability and Late Potential analysis, the "tolerance" statements imply the device's measurements were compared against a reference standard for accuracy, which would constitute the ground truth. However, the nature of this reference standard (e.g., a gold standard measurement, expert-derived ground truth) is not specified.
• For the ST segment algorithm, it states a "database has been used as a tool for performance testing." The ground truth for this database to assess "accuracy" of ST segment data is not explicitly stated (e.g., expert consensus, pathology, follow-up outcomes). The "significance of the ST segment changes must be determined by a physician" suggests clinical interpretation is ultimately required.

8. Sample Size for the Training Set:

• This information is not provided in the document. The document refers to "testing" with a database but does not distinguish between training and test sets.

9. How the Ground Truth for the Training Set Was Established:

• As no information about a training set is provided, the method for establishing its ground truth is also not mentioned.

Ask a specific question about this device

Ask a specific question about this device

Not Found

Stress and ECG systems contain digital and analog hardware, associated firmware and software, which must perform effectively, accurately, and reliably.

The provided text is a summary of safety and effectiveness information for the "PC ECG 1200 ECG and Stress Electrocardiography System." It discusses various factors that can affect the effectiveness of the system, such as lead placement, line interference, EMG interference, baseline wander, and averaging. It also briefly mentions the importance of "Diagnostic Accuracy" for ST measurements, QRS detector, and VE detector.

However, the document does not provide acceptance criteria in a structured table, nor does it present the results of a specific study to prove the device meets those criteria. It references standards (ANSI/AAMI EC11-1982, IEC 601-1, 601-2, 601-3) that likely contain such criteria and test methodologies, but the criteria themselves and the device's performance against them are not detailed in this excerpt.

Therefore, for your specific questions, I can only extract limited information based on what is directly stated:

Here's a breakdown of what can and cannot be answered from the provided text:

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

• Cannot be provided. The document states that "Standards and test methods for the performance of these systems are compiled in detail in ANSVAAMI EC11-1982 and IEC 601-2 and 3" and that "Testing of the diagnostic accuracy of the ST measurements, QRS detector and VE detector are necessary to evaluate the value of the measurements and trends supplied to the physician for review." However, it does not actually list specific numerical acceptance criteria or the device's performance against them.

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

• Cannot be provided. This information is not present in the document.

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)

• Cannot be provided. The document does not describe a clinical study with expert adjudication for ground truth.

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

• Cannot be provided. The document does not describe a clinical study with an adjudication method.

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

• Cannot be provided. The document does not describe a MRMC study, nor does it refer to AI assistance.

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

• Cannot be provided. While the document refers to "algorithms used to make such measurements," it does not describe a standalone performance study.

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

• Cannot be provided. The document mentions the need for "diagnostic accuracy testing" but does not specify how ground truth would be established for such testing.

8. The sample size for the training set

• Cannot be provided. The document does not describe a training set for an algorithm.

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

• Cannot be provided. The document does not describe a training set.

In summary, the provided safety and effectiveness information focuses on general considerations for ECG and stress systems, potential issues (like interference), and a general statement about the need for diagnostic accuracy testing as per existing standards. It lacks the specific details of a study that would demonstrate the device's performance against defined acceptance criteria.

Ask a specific question about this device