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The PC-ECG system is a fully featured, non-invasive, real-time, 12-lead ECG system capable of recording, display and storage of data using a PC (personal computer). It is used in doctor's offices by cardiologists to record the clectrical heart signals (electrocardingram) of patients in order to detect abnormal heart conditions.
Patients are hooked up to the PC-FCG system via cables connected to the extremities and the chest using rubberized disks which contain in a small central depression a paste.
The device is for prescription use only.

Versatile 12-lead electrocardiograph system (ECG) for use with PCs.
Recording and display of 1, 3, 6, 12 channels
Monitoring of up to 12 channels with acoustic, analogue and digital pulse signal
Single user system or network ready
Storage of unlimited number of 10 sec. ECGs
High quality print of 6, 12 leads with variable speed
Patient database

The provided document, K963578, is a Premarket Notification [510(k)] Summary for a device called "PC-ECG." It is a 1997 submission so the details on the acceptance criteria and the study that proves the device meets the acceptance criteria are not as granular as modern submissions.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the PC-ECG device. The submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (CC Cardio-Card, Nasiff Associates). The letter from the FDA confirms this determination of substantial equivalence.

The "Technological characteristics" section states: "The two systems compared are very similar in their design. Both units measure the low-voltage signals generated by the heart, amplify the signals, perform an analog/digital conversion and transmit the data to a personal computer (PC) for display and evaluation. The main differences are in the features provided by the software."

This implies that the acceptance criterion was likely that the PC-ECG device performs comparably to the predicate device in its fundamental functions (measuring, amplifying, converting, and transmitting ECG data) and that its software features either do not negatively impact safety and effectiveness or offer equivalent functionality. However, no specific performance values are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide any information regarding the sample size used for a test set, nor does it specify the data provenance (country of origin, retrospective/prospective). This level of detail was not typically required or included in 510(k) summaries from 1997, which often relied on comparative claims to predicate devices rather than extensive clinical trial data for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for a test set. Given the nature of a 510(k) submission from this era focusing on substantial equivalence for an electrocardiograph, it's highly unlikely that an independent expert panel was used to establish ground truth in the way it might be for a novel diagnostic algorithm.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

No information is provided regarding an adjudication method. This type of detail is usually associated with studies involving human interpretation and clinical endpoints, which are not described in this 510(k) summary.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device, "PC-ECG," is an electrocardiograph system for recording, display, and storage of ECG data, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with or without AI assistance. Therefore, there is no mention of effect size for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe a standalone performance study in the context of an algorithm's diagnostic accuracy. The device itself is a measurement and display tool. Its "performance" would likely be related to the accuracy of its electrical signal acquisition and display, which is not specifically quantified in the summary, beyond the claim of substantial equivalence to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify a type of ground truth used, as it doesn't describe a study where ground truth for a diagnostic endpoint against a device's classification was established. The "ground truth" for an ECG device would inherently be the true electrical activity of the heart, measured against established physiological principles and comparison to a legally marketed predicate device accepted as accurately capturing this activity.

8. The sample size for the training set

The document does not mention a training set or its sample size. This device is a measurement and display system, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

As there is no mention of a training set, there is no information on how its ground truth would have been established.

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