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ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients:

1. 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. QT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacologic therapy. 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 PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability within 1 millisecond tolerance. The clinical significance of HRV measures should be determined by a physician.
5. The PCECG-1200 System With MEANS has been tested to measure Late Potential within 1 millisecond tolerance in the time domain, and 1 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 PCECG-1200 System With Modular ECG Analysis System (MEANS) is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The System comprises:

• · Data Acquisition Unit
• · RF transceiver
• · USB communications cable
• · Software application
• · Software access security lock (dongle), optional

The system acquires ECG data and displays it on the color monitor, calculates and controls some parameters of ECG display such as sweep speed, filters line interference and muscle noises introduced during monitoring, makes necessary outputs, handles the user interface, and controls the flow of operations.

Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of real time ECG display are possible. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard.

ECG is analyzed by the Modular ECG Analysis System (MEANS), which is a cleared O.E.M. SW Application obtained by Norav from the producer: the Department of Medical Informatics Erasmus University Medical Center Rotterdam, the Netherlands.

The provided document is a 510(k) Summary for the NORAV PCECG-1200 System with Modular ECG Analysis System (MEANS). It outlines the device's intended use, technological characteristics, and substantial equivalence to predicate devices. However, it does not contain the specific details about acceptance criteria or a dedicated study that proves the device meets those criteria in a way that directly maps to your requested table and study information.

Instead, the document makes general statements about testing and performance. It mentions:

• "The PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability within 1 millisecond tolerance."
• "The PCECG-1200 System With MEANS has been tested to measure Late Potential within 1 millisecond tolerance in the time domain, and 1 microvolt tolerance in voltage."
• "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."

These are statements about what was tested and the reported performance, but they lack the full context of "acceptance criteria" (i.e., the predefined thresholds that must be met for approval) and the detailed methodology of the studies.

Therefore, many of the requested fields cannot be extracted directly from this document.

Here's how I can address your request based on the available information, noting where data is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly suggests these tolerances are "acceptance criteria" because it states the device "has been tested to measure... within" these values. However, it does not explicitly define these as pre-established acceptance criteria that had to be met. For ST segment accuracy, no specific numerical criterion is provided, only that it was "tested for accuracy."

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document only mentions that a "database has been used as a tool for performance testing" for the ST segment algorithm.
• Data provenance: Not specified for any of the performance claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method 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

• No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in this document. The device is for automated ECG analysis.

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

• Yes, the performance claims strongly suggest standalone (algorithm-only) testing as the device is an "ECG Analysis System" intended for automated analysis. For example, "The PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability..." implies testing the algorithm itself.

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

• Not explicitly stated. For Heart Rate Variability and Late Potential, the "tolerance" suggests a comparison against a highly accurate reference measurement or a gold standard method. For the "ST segment algorithm accuracy," it refers generally to a "database," but the nature of the ground truth within that database (e.g., expert annotations, confirmed diagnoses) is not detailed.

8. The sample size for the training set

• Not specified. The document states the MEANS software is a "cleared O.E.M. SW Application obtained by Norav from the producer: the Department of Medical Informatics Erasmus University Medical Center Rotterdam, the Netherlands." This implies the training (and development) was done by the OEM.

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

• Not specified. This information would typically reside with the original developer of the MEANS software, not necessarily in this 510(k) submission.

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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.

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The Norav Holter Analysis System is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below:

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2 ) Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery.)

5. Clinical and epidemiological Research Studies

6. Norav Holter Systems containing Heart Rate Variability (HRV) software have been of Tronor Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician.

7. Evaluation of patients with pacemakers.

Not Found

This FDA 510(k) clearance letter for the Norav Holter Analysis System, Model NH-300, V1.07, does not contain the detailed acceptance criteria or a study description as requested.

The document is a regulatory approval letter, which primarily states that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide specific performance metrics, study designs, or data provenance.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) submission document or a separate clinical study report for the Norav Holter Analysis System.

Ask a specific question about this device

Ask a specific question about this device