Search Results

Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.

Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.

Disposable ECG Cable and Leadwires with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.

These devices consist of connectors on each cable end and a shielded bulk cables are used to transfer the signals from the electrodes to the patient monitor.

These devices use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.

The provided text describes the regulatory clearance of a medical device, the "Med-link Disposable ECG Cable and Leadwires," but it does not contain information about a study proving the device meets acceptance criteria in the way you've outlined.

The document is a 510(k) premarket notification summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical or detailed standalone studies.

Here's a breakdown of why this document doesn't fit your request and what information it does provide:

• Type of Device: The device is a Disposable ECG Cable and Leadwires, which is an accessory to ECG monitoring devices, not a diagnostic algorithm or AI system. Therefore, the concepts of "sensitivity," "specificity," "AI improvement," "training sets," "test sets," "ground truth," or "expert adjudication" as typically applied to AI/ML medical devices are not relevant here.
• Purpose of 510(k): The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Given this context, I cannot fill out your requested table and information points as they pertain to a different type of device evaluation (e.g., for an AI/ML diagnostic software).

However, I can extract the information that is relevant to the document provided:

Summary of Device Evaluation (as per the 510(k) Summary):

Acceptance Criteria and Device Performance (based on regulatory standards rather than clinical endpoints):

Here's why the other points you requested are not available in this document:

1. Sample size used for the test set and data provenance: Not applicable. This device is an accessory (cable/leadwire) and its performance is evaluated against engineering/safety standards (IEC, AAMI, ISO), not clinical data sets with "test sets" or "data provenance" in the context of an algorithm. The testing involves bench and type testing of the physical device according to standards.
2. Number of experts used to establish the ground truth... and their qualifications: Not applicable. There is no "ground truth" to establish through experts for an ECG cable's performance in the way a diagnostic algorithm requires. Compliance to standards is verified through laboratory testing.
3. Adjudication method: Not applicable. No human adjudication is mentioned or relevant for electrical and biocompatibility testing of a cable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML diagnostic device, so MRMC studies are irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, verified through bench testing.
7. The sample size for the training set: Not applicable. There is no "training set" for an ECG cable.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document details the "substantial equivalence" of an ECG cable to a predicate device by demonstrating compliance with relevant international and national standards for electrical safety, performance, and biocompatibility through non-clinical (bench and type) testing, not through a clinical study with acceptance criteria for diagnostic accuracy metrics.

Ask a specific question about this device