Search Results

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.

Ask a specific question about this device