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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Non-clinical Tests:
Common mode rejection	Passed (implied "no safety question")
Frequency response	Passed (implied "no safety question")
Sound level of the audio signal	Passed (implied "no safety question")
Temperature stress	Passed (implied "no safety question")
Ratio (unspecified type of ratio)	Passed (implied "no safety question")
Electromagnetic immunity	Passed (implied "no safety question")
Shock and vibration	Passed (implied "no safety question")
Clinical Tests:
Equivalence in quality of transmitted ECGs to predicate device (Heart 1001)	"The quality of the electrocardiograms in every case is equivalent."
Equivalence in safety and efficacy to predicate device	"The Heart 400 is equivalent in safety and efficacy to its predicate device."

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.

Summary

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JUL 18 1996

Aerotel Ltd. Heart 400 ECG Transmitter K953762 Request for Additional Information K953762 July 15, 1996 revised 510(k) Summary

AEROTEL LTD.

510(k) Submission

Heart 400 ECG Transmitter (H400)

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements Regulation par 807.92, effective March 14, 1 ପିଟିର୍ତ୍

1. Submitter
  Name: Aerotel Ltd Address: 5 Hazoref St., Holon 58856, Israel Telephone Number: 972-3-5596111 Contact person: Dr. George Myers, 201-438-2310 Date prepared: July 13, 1995.

2. Device

Proprietary name: Heart 400 Common Name: Electrocardiograph Telephonic Transmitter Classification Name: Transmitters and Receivers, electrocardiograph, telephone

The Heart 400 is a battery-powered ECG transmitter that is capable of transmitting a 3-channel ECG signal by means of a telephone to a central receiving station.

1. Predicate Device
  Aerotel Heart 1001 ECG Transmitter, K931020

4. Description

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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.

5. Intended Use

6. Comparison

The Heart 400 has basically the same physical characteristics as the predicate device, except that the Heart 400 does not have a memory. Thus, when the Heart 400 is used, the electrocardiogram is transmitted on the telephone at the same time it is taken, while with the Heart 1001 there can be a time lag. Apart from that, both use FM transmission, similar circuitry, and similar patient electrodes. This difference is not critical to the use of the device, because the Heart 400 is used when the electrocardiogram is to be transmitted immediately.

b. Performance Data

(1) Non-clinical tests

Non-clinical tests provided include bench tests of common mode rejection frequency response, sound level of the audio signal, temperature stress, ratio, electromagnetic immunity, and shock and vibration. There is no safety question, since the Heart 400 is battery operated.

(2) Clinical Tests

Electrocardiograms were taken from three volunteers using the Heart 400 and the Heart 1001, and transmitting the electrocardiograms over telephone lines. The quality of the electrocardiograms in every case is equivalent.

(3) Conclusion

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The conclusion drawn from these tests is that the Heart 400 is equivalent in safety and efficacy to its predicate device

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).