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The Biosensor CMS Holter Analysis system is intended for patients requiring anbulatory monitoring is most frequently used for the indications below.

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2. Evaluation of Symptoms suggesting army announce of the works 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. Evaluation of patients with pacemakers
7. Reporting of time and frequency domain heart rate variability
8. Reporting of QT Interval.

Holter analysis systems contain software, which must perform effectively, accurately, and reliably.

I understand you're asking for information about a device's acceptance criteria and a study proving it meets those criteria. However, the provided text does not contain the acceptance criteria or a study that rigorously proves the device meets specific performance metrics.

The text is a 510(k) submission and FDA clearance letter for a Holter Monitor System Software from 1999. It discusses general principles of safety and effectiveness for Holter systems but does not provide specific quantitative acceptance criteria or a study design to meet them for this particular device.

Here's what the provided text does say, and why it doesn't fulfill your request:

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

• Acceptance Criteria: The document mentions "Recommended standards and test methods for the performance of these systems are also compiled in detail in the Association for the Advancement of Medical Instrumentation draft standard for Holter systems." It also lists areas for effectiveness like "Diagnostic Accuracy (In Holter systems that measure heart rate, arrhythmia content, ST values and other ECG parameters, the algorithms used to make such measurements and report trends to the physician influence the quality of information provided to the physician. 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."
• Reported Device Performance: The document does not report any specific performance metrics for the Biosensor CMS Holter Analysis System. It's a regulatory clearance document, not a clinical study report.

Therefore, a table cannot be constructed from the provided text.

Regarding the other points you requested:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text.
• 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 provided in the text.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
• 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 provided in the text. (This document predates modern AI as defined by such studies).
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the text.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The text generally refers to "diagnostic accuracy" of measurements (ST, QRS, VE detection), implying comparison to a "true" or established value, but does not specify how this ground truth was established.
• 8. The sample size for the training set: Not provided in the text.
• 9. How the ground truth for the training set was established: Not provided in the text.

In summary: The provided document is a 510(k) FDA clearance letter for a Holter monitor system from 1999. It outlines general safety and effectiveness considerations and refers to external standards (like AAMI draft standards) for performance testing. However, it does not include the actual acceptance criteria or any study results demonstrating the device's performance against specific metrics. To obtain this information, one would typically need to review the full 510(k) submission, clinical study reports, or performance testing documentation submitted to the FDA for this device, which are not present in the given text.

Ask a specific question about this device

The Biosensor Frequency Domain Heart Rate Variability (FD HRV), analysis option is being incorporated into the Biosensor Holter Monitor System for quantification and graphical displays of heart rate changes over a specific monitoring period as an aid to other clinical diagnostic techniques. The FD HRV graph is modeled after the recommendations of the Task Force of the European Society of Cardiology (Circulation. 1996;93: 1042-1065). FD HRV is intended to provide HRV spectra for any selected time segment of 5 minutes of duration or longer, at the physician's discretion.

Not Found

The provided text is a 510(k) clearance letter and an "Indications For Use" statement for the "BIOSENSOR HOLTER MONITOR SYSTEM." It does not contain any information regarding acceptance criteria, reported device performance, sample sizes for testing, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth used, or training set specifics.

The letter from the FDA (MAR - 4 1998) confirms that the Biosensor Holter Monitor System (K974192) has been determined to be substantially equivalent to devices marketed prior to May 28, 1976. The "Indications For Use" section describes the function of the device's Frequency Domain Heart Rate Variability (FD HRV) analysis option as an aid to other clinical diagnostic techniques for quantifying and graphically displaying heart rate changes. It also includes precautions and notes that validation data for FD HRV will be made available upon request.

Therefore, I cannot provide the requested information based on the given input.

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The Biosensor Holter Monitor System is intended for patients requiring ambulatory (Hotter) monitoring from 1 to 24 hours. Such monitoring is most frequently used for the indications below, (Portions from Ambulatory Electrocardiograph Recording, Wegner NK, Mock MB, and Reingquist I, Year Book Medical Publishers, 1981.)

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 patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)

5. Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.

6. Clinical and epidemiological research studies.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Biosensor Holter Monitor System, which declares the device substantially equivalent to a predicate device.

While it mentions the intended use of the device, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number or qualifications of experts, adjudication methods for ground truth, or types of ground truth used in any specific study.
• Information regarding multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details.

This type of information would typically be found in a separate clinical study report or a more detailed section of the 510(k) submission, not in the clearance letter itself.

Ask a specific question about this device