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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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