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The Aerotel Medical Systems (1998) Ltd BP-Tel Trans-Telephonic Monitoring system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The BP-Tel is not intended for patients with defibrillators.

The system includes a home blood-pressure measuring device that makes use of the oscillometric system, a means for sending the measurements over the telephone lines to a central station, and a computer program at the central station for receiving the measurements, storing them in a data base, and preparing reports.

The provided document, a 510(k) summary for the Aerotel BP-Tel Trans-Telephonic Blood Pressure Measurement System, offers limited information regarding specific acceptance criteria and the detailed study proving it. However, based on the available text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: "The entire system has been tested in a clinical test with volunteer subjects." The exact number of volunteer subjects is not specified in the document.
• Data Provenance: The study was a "clinical test." The country of origin is not explicitly stated for the clinical test, but the company is based in Israel, so it's plausible the study was conducted there or in the US (given the FDA submission). It was a prospective study as it involved testing the system in a clinical setting.

3. Number of Experts and Qualifications

• Not applicable / Not specified. The document does not mention the use of experts to establish a ground truth for the clinical test beyond the standard clinical assessment methods that would be used for blood pressure measurement. The core blood pressure device itself was a "cleared device," implying its accuracy was already established.

4. Adjudication Method

• Not applicable / Not specified. Given the nature of a blood pressure measurement device testing, an adjudication method like 2+1 or 3+1 typically applies to subjective interpretations (e.g., radiology images). For quantitative measurements like blood pressure, the ground truth is usually established through a reference standard measurement, not expert consensus on interpretation.

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

• No. An MRMC study is not mentioned as this device is for measuring and transmitting blood pressure, not for interpretation tasks that involve human readers. The clinical test involved the device's performance, not a comparison of human readers with and without AI assistance.

6. Standalone Performance Study

• Most likely, yes, for a component. The statement "The actual blood-pressure device is a cleared device purchased for this system" implies that the core blood pressure measurement algorithm (which could be considered a standalone algorithm) had undergone its own performance evaluation to achieve clearance. The current submission focuses on the system (measurement + telephonic transmission). The "extensive validation testing" for the MPM software also indicates a standalone assessment of that software component.

7. Type of Ground Truth Used

• Reference Standard Measurement (Inferred): For the blood pressure component, the ground truth would have been established by comparing the device's readings against a recognized standard method for blood pressure measurement (e.g., a mercury sphygmomanometer or another validated oscillometric device).
• System Functionality Verification: For the transmission and data handling aspects, the ground truth would be whether the data was accurately transmitted, stored, and displayed as received from the device's measurements.

8. Sample Size for the Training Set

• Not applicable / Not specified. Blood pressure monitors typically rely on established physiological principles and algorithms rather than machine learning models that require large training sets in the same way an AI diagnostic tool would. While there might be some internal calibration or algorithm development, the document doesn't mention a distinct "training set" in the context of an AI/ML algorithm. The core blood pressure device was "cleared," meaning its underlying algorithms and parameters were already validated.

9. How Ground Truth for Training Set was Established

• Not applicable / Not specified. As mentioned above, a traditional "training set" with ground truth in the AI/ML sense is not indicated for this type of device. The accuracy of the blood pressure measurement component would have been established during its original clearance, likely through comparison to gold-standard manual measurements on a diverse population.

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The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The device is not intended to be used for long-term monitoring or when the patient is not capable of actuating the device or the telephone.

The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The Heart 400 transmits each of leads I, II, III as selected by the patient. Patient connection is done by means of electrodes and a patient cable. The electrodes are attached by the physician. To transmit the electrocardiogram, the telephone handset transmitter is placed over the device and the On/Off button of the H400 is released. At the receiving center, the ECG will be edited and recorded.

Here's an analysis of the provided text regarding the Aerotel Heart 400 ECG Transmitter's acceptance criteria and studies:

Based on the provided text, the device is extremely simple, and the "study" is equally simple. It involves a comparison of ECG signal quality transmitted by the new device vs. the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Three volunteers.
• Data Provenance: Not explicitly stated, but given it's a 1996 submission from Aerotel Ltd. in Israel, the volunteers likely originated from Israel. The study appears to be prospective as it involves "volunteers" specifically undergoing testing for this submission.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It simply states that "The quality of the electrocardiograms in every case is equivalent," implying an internal assessment, but without detailing who performed this assessment.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method. The assessment of "equivalent quality" appears to be a direct conclusion from comparing the transmitted ECGs.

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, an MRMC comparative effectiveness study was not conducted. This device is a simple ECG transmitter, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable to the Heart 400. The device itself is a signal transmitter, and its "performance" is assessed by the quality of the transmitted signal, not by an algorithm's diagnostic capabilities. The study assesses the device's ability to transmit an ECG, which would then be interpreted by a human at a receiving center.

7. The Type of Ground Truth Used

The ground truth for the clinical test was the quality of the electrocardiograms taken from the volunteers using both the Heart 400 and the predicate device (Heart 1001). The "ground truth" was essentially the visual and expert assessment of whether the transmitted ECGs were of comparable quality. This is an implied "expert consensus" on signal quality, though the experts are not quantified or qualified.

8. The Sample Size for the Training Set

There is no mention of a "training set" for this device. This is not an AI/ML device that requires training data. The "study" described is purely for performance testing and comparison to a predicate.

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

Not applicable, as there is no training set for this device.

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