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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.

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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.

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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.

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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.

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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.

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Ask a specific question about this device

Ask a specific question about this device