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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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Section 2 - Safety and Effectiveness Information
2.1 Summary of Safety and Effectiveness Information
Safety
Stress and ECG systems can be sources for macroshock and microshock hazards for the patient and the user. Details and protection requirements are explained in 'Medical Instrumentation: Theory and Application:, J.G. Webster, Ch. 13, 1978. These protection requirements are compiled into National and International Safety Standards. The most comprehensive ones are ANSI/AAMI/ES-1 and IEC 601-1 and 2.
For safe use of Stress and ECG systems, labeling and documentation must be complete. Standards for these are also covered in the above mentioned standards and also in ANSI/AAMI EC11-1982.
Effectiveness
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Stress and ECG systems contain digital and analog hardware, associated firmware and software, which must perform effectively, accurately, and reliably. Standards and test methods for the performance of these systems are compiled in detail in ANSVAAMI EC11-1982 and IEC 601-2 and 3.
In addition to these, because of lack of proper user training, problems may arise regarding the following:
(a) Lead placement (Correct positions for electrodes are explained in ECG textbooks such as "Harrison's Principles of Internal Medicine", Eds. R.G. Fetersdorf, R.D. Adams, E. Braunwald, K.J. Isselbacher, J.B. Martin and J.D. Wilson, 100 edition, pp: 1320-21. McGraw Hill, 1983).
(b) Line Interference (A comprehensive reference list for causes and reduction methods for line interference is given in "A new technique for line interference monitoring and reduction in biopotential amplifiers", Y.Z. Ider and H. Koymen, IEEE Trans. Biomedical Engineering, Vol. 37, pp. 624-31, 1990.) 50/60 Hz Notch filters can reduce partially or substantially an problems with line interference.
(c) EMG (myopotential) interference (A low pass filter may be provided as an option as too much muscle interference may be encountered during an ECG or stress recording. Users should be notified continuously when this filter is in use, since low pass filters may affect the diagnostic value of the ECG recording information. The PC ECG 1200 ECG and Stress Electrocardiography System provides such notification on screen.)
(d) Baseline wander (High pass correction filters may be provided as an option as baseline wander may occur during ECG or stress recording. Users should be notified continuously when this filter is used, since baseline wander filters may affect the diagnostic value of the recording. The PC ECG 1200 ECG and Stress Electrocardiography System provides such notification on screen.)
(e) Averaging (In Stress and ECG systems, ST level changes must be accurately measured for each lead and at each exercise step. Due to myopotential, baseline wander and other noise interference, such measurements cannot be reliably made using a single beat. Therefore,
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beats are averaged and measurements are made from average beats to minimize errors. These average beats must be recorded for every exercise step level during stress testing.)
(f) Diagnostic Accuracy (In Stress and ECG systems that measure heart rate, 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.)
2.2 Certification:
I certify that we have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the PC ECG 1200 ECG and Stress Electrocarc ു raphy System. I further certify that I am aware of the types of problems to which the PC ECG 1200 ECG and Stress Electrocardiography System is susceptible and that the above summary of the types and causes of safety and/or effectiveness problems about the PC ECG 1200 ECG and Stress Electrocardiography System is complete and accurate
Steve Springrose
Steve Springróse President Biosensor Corporation January 23, 1996
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).