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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 HeartView P12/8 is a 12/8-lead Transtelephonic electrocardiographic recorder and transmitter which is intended to be used to record and transmit a patient's electrocardiogram (ECG) via the telephone to a diagnostic/emergency center. The HeartView P 12/8 can record either an eight lead or a twelve lead electrocardiogram, and has been designed so that the patient can attach the electrodes him/herself.

The HeartView P12/8 is a 12/8-lead Transtelephonic electrocardiographic recorder and transmitter which is intended to be used to record and transmit a patient's electrocardiogram (ECG) via the telephone to a diagnostic/emergency center. It is a modification to the Aerotel HeartView event recorder, K950004. For the original HeartView, the patient had 10 standard disposable electrodes attached to his chest by a physician, and the unit always recorded and over and electrocardiogram. The HeartView P 12/8 can record either an eight lead or a 12 clead electrocardiogram, and has been designed so that the patient can attach the electredes him/le rself.

To record an 8-lead electrocardiogram, three standard disposable electrodes are attached to the patient's chest, and in addition the patient places the recorder in a specific place on his chest and makes recordings using "button" electrodes embedded in the case. To record a 12-lead electrocardiogram, the disposable electrodes are in the same locations but the patient makes three recordings using the embedded "button" electrodes, each with the recorder in a different location on the chest (also explained later). The system is designed so that the patient can attach the electrodes and place the embedded electrodes him/herself with the recorder in the proper locations. Clinical tests have been done which show that the electrocardiograms produced when the patient attaches the electrodes and manipulates the recorder are of the same quality as in the original HeartView, K950004, in which disposable electrodes are attached by the physician.

Heart View P12/8 has internal memory, which enables it to record and store the ECG of a cardiac event when the Record Transmit button is pressed. The stored ECG can then be transmitted to the center by telephone at a later time. Transmitting the ECG does not erase it, so that an inadvertent or faulty transmission does not affect the recording.

The system is designed so that the patient can record an episode on the recorder and then transmit it in a simple, non-confusing way.

The provided text describes the HeartView P 12/8 Event Recorder and its clinical testing. However, it does not explicitly state "acceptance criteria" in the format of specific quantitative thresholds. Instead, the study's goal was to demonstrate equivalence in quality between ECGs recorded by the new device (patient-attached electrodes) and the predicate device (professionally-attached electrodes).

Here's an interpretation of the information based on the provided text, structured to answer your questions:

Acceptance Criteria and Device Performance Study

The primary acceptance criterion for the HeartView P12/8 was the equivalence of electrocardiogram (ECG) quality when electrodes were attached by the patient, compared to the predicate device where electrodes were professionally attached.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The text mentions "a clinical test" and "the electrodes were given to a cardiologist for comparison," but does not provide details on the number of patients or ECGs involved in this comparison.
• Data Provenance: Not explicitly stated. Given the submitter's address in Israel (Aerotel Ltd., Holon, Israel), it is likely the clinical tests were conducted in Israel, but this is not confirmed in the document. The study was presented as a prospective comparison of the new device's method against the predicate device's method.

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

• Number of Experts: One ("a cardiologist").
• Qualifications of Experts: A "cardiologist." No further details on experience level (e.g., years of experience) are provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not formally described (e.g., 2+1, 3+1). The ground truth was established by a single cardiologist who compared the ECGs. There is no mention of multiple readers or an adjudication process for discrepancies.

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

• Was an MRMC study done? No. The study involved a single cardiologist making a comparative judgment, not an MRMC study designed to assess improvement of human readers with AI assistance. This device is an event recorder, not an AI-driven diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Was a standalone study done? Not applicable in the context of an "algorithm only" study as understood for AI devices. The device's performance was assessed by human evaluation of the ECG output, focusing on the quality of the waveform itself when recorded by the patient versus a professional. It's a device that records, stores, and transmits ECGs, not one that automatically interprets them via an algorithm for standalone performance evaluation.

7. Type of Ground Truth Used:

• Type of Ground Truth: Expert consensus (from a single cardiologist) and comparative assessment of ECG quality. The ground truth was the cardiologist's judgment that the ECGs were "equivalent in quality."

8. Sample Size for the Training Set:

• Sample Size: Not applicable/not specified. This device is a hardware event recorder with a simple recording/transmission function. It is not an AI/ML model that undergoes a "training set" process in the conventional sense. The "training" in this context refers to the development and iterative design of the device itself rather than a data-driven model training.

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

• How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there is no "training set" for an AI/ML model. The device's design and functionality were refined through engineering and clinical understanding of ECG recording, likely informed by previous device designs (like K950004) and medical requirements for ECG quality.

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The Telelink is a battery powered device intended to be used by the physician in his office, for the transfer of an ECG signal received over the telephone from a compatible transmitter, to a conventional single trace ECG recorder in the physician's office . The patient has no contact with the Telelink, and it does not affect him in any way.

The Telelink is a battery powered ECG telephone receiving interface that is capable of transferring the transtelephonic ECG, received over the telephone, to a conventional single trace ECG recorder.
The Telelink is a battery powered interface which is intended to be used by a physician or an ECG technician to convert an ECG signal received via the telephone to an analog ECG signal recordable on the physician's conventional single trace ECG recorder.
The Telelink has two connections; one of these is connected to the telephone's handset via an acoustic coupler (included) which is placed on the speaker of the handset; the other connection is attached to the single-trace ECG recorder in the physician's office via the recorder's patient cable by using only 3 wires of the patient cable.
After activating the recorder, all received ECG leads from the telephone, will be routed to the recorder will print them out, one after the other, in the sequence in which they have been transmitted.

Here's an analysis of the provided text regarding the Aerotel Telelink device, focusing on its acceptance criteria and the study conducted.

It's important to note that this document is a 510(k) summary from 1996 for an ECG telephonic receiving interface. Such summaries typically focus on demonstrating substantial equivalence to a predicate device, rather than establishing de novo clinical efficacy with rigorous, broad-based studies common for novel devices or AI algorithms today. Therefore, many of the detailed criteria you've requested (like MRMC studies, specific effect sizes, or large training sets for AI) are not applicable or not present in this type of submission.

Acceptance Criteria and Device Performance for Aerotel Telelink K961362

The Aerotel Telelink is an ECG telephonic receiving interface designed to transfer an ECG signal received over the telephone to a conventional single-trace ECG recorder. The core acceptance criterion for this 510(k) submission is substantial equivalence to its predicate device, the Aerotel Heartline Receiving Console (K930314), in terms of safety and efficacy (diagnostic utility and quality of ECGs).

Specifically, the device aims to:

• Convert an ECG signal received via telephone to an analog ECG signal recordable on a conventional single-trace ECG recorder.
• Produce ECG prints that are equivalent in quality and diagnostic utility to those produced by 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" were used.
• Data Provenance: The location where the volunteers were recruited and the study conducted is not explicitly stated, but the company address is in Holon, Israel. The study was prospective in nature, as ECGs were "taken from three volunteers transmitting over the phone" for the purpose of this comparison.

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

• The document does not mention the use of experts to establish a "ground truth" in the traditional sense for diagnostic accuracy.
• Instead, the comparison was made between the ECGs produced by the Telelink and the ECGs produced by the predicate device. The judgment of "equivalent in quality and diagnostic utility" would have been made by the manufacturer's internal personnel, likely with medical or technical expertise, but this is not detailed. There's no mention of external, independent experts for a formal ground truth evaluation.

4. Adjudication Method for the Test Set

• No formal adjudication method (like 2+1, 3+1) is described for determining the equivalence of ECG quality or diagnostic utility. The statement is a direct conclusion that the "electrocardiograms from the two systems are equivalent." This suggests an internal assessment rather than an adjudicated consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance to quantify improvement) is not relevant for this device, which is an interface, not an AI diagnostic algorithm.

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

• Yes, in spirit, a standalone performance was evaluated. The "clinical tests" describe the device (Telelink) receiving and printing ECGs, which were then compared to the predicate device's output. While a human makes the ultimate determination of "equivalence," the device's function as an interface to produce the ECG is essentially evaluated in a standalone manner (without another human intervening in the signal transmission/recording between the Telelink and the final printout, other than operating the equipment). However, this isn't an "algorithm only" study as the device is hardware.

7. The Type of Ground Truth Used

• The "ground truth" here is best described as "predicate device performance comparison." The ECGs produced by the predicate device served as the reference standard for quality and diagnostic utility. It wasn't pathology, outcomes data, or an independent expert consensus on a disease state, but rather a direct comparison of the output signal quality to a legally marketed equivalent device.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware interface, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and engineering were based on established principles of signal processing and telecommunications.

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

• Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth for it to be established.

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