Search Results

Philips ECG leadsets are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

The Philips ECG Leadwire Set is a single patient electrode cable system used to transfer signals from patient electrodes to various electrocardiograph recorders and monitors. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

This document describes the 510(k) premarket notification for the Philips ECG Leadwire Set (K110287). This submission is for a medical device (leadwire set) and not an AI/ML powered device, therefore much of the requested information (sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies) is not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with established electrical and biocompatibility standards, and the "reported device performance" is the claim of substantial equivalence to the predicate device based on meeting these standards and having similar technological characteristics.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as this is a traditional medical device submission (ECG leadwire set) and not an AI/ML device that would involve a "test set" of data in the sense of patient data for model evaluation. The "testing" referred to is engineering verification testing against recognized standards, not performance evaluation on a patient dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the context of AI/ML, refers to reference labels for a dataset. For this device, the "ground truth" is defined by compliance with established engineering and biocompatibility standards. Expert review would be part of the internal design and testing process, but not in the format of "ground truth" for a dataset.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the AI/ML context described.

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 is relevant for AI/ML-powered diagnostic or screening devices to assess how the AI impacts human reader performance, which is not applicable to a passive leadwire set.

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

No, a standalone performance study was not done. This is also relevant for AI/ML algorithms and not for an ECG leadwire set, which is a physical component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is compliance with recognized international and national standards for medical electrical equipment, cardiac monitors, ECG cables and leadwires, and biological evaluation of medical devices. This involves objective measurements and assessments against predefined criteria specified in these standards.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML algorithm requiring a "training set" for this device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device