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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 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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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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