(227 days)
The NeoLead Hydrocolloid/ Hydrogel electrode is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting.
The Neolead is a self-adhesive, disposeable sensor, which receives electrical impulses from the body in a non-invasive manner. These impulses are then transmitted to a monitor, which displays the electrographic patterns of cardiac activity. Hydrogel is the pectin based conductive material between the skin and the sensor. Hydrocolloid is the pectin based adhesive.
This document outlines the acceptance criteria and study findings for the Neolead device, as extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (AAMI for Disposable ECG Electrodes) | Reported Device Performance (Neoleads) |
|---|---|
| 3.2.2.1 AC Impedance | Meets standard |
| 3.2.2.2 DC Offset Voltage | Meets standard |
| 3.2.2.3 Combined Offset Instability and Internal Noise | Meets standard |
| 3.2.2.4 Defibrillation Overload Recovery | Meets standard |
| 3.2.2.5 Bias Current Tolerance | Meets standard |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The information rather refers to meeting "basic performance standards" of AAMI (Association for the Advancement of Medical Instrumentation) for Disposable ECG Electrodes. This implies a general compliance check rather than a specific clinical trial with a defined test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The provided text does not mention the use of experts to establish ground truth for a test set. The evaluation is based on meeting technical performance standards, not on expert interpretations of clinical data.
4. Adjudication Method for the Test Set
The provided text does not describe an adjudication method for a test set. The evaluation is based on technical performance against AAMI standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The Neolead is an ECG electrode, a hardware device for signal acquisition, not a software or AI-based diagnostic tool that would typically undergo such a study to assess reader improvement. Therefore, there is no information on effect size for human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
The provided text does not describe a standalone performance study in the context of an algorithm. The Neolead is a physical device (an electrode), and its performance is evaluated based on its ability to acquire electrical signals according to established technical standards.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Neoleads is based on technical performance standards outlined by the AAMI for Disposable ECG Electrodes (specifically sections 3.2.2.1 to 3.2.2.5). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's regulatory review.
8. The Sample Size for the Training Set
The provided text does not mention a training set sample size. As the Neolead is a hardware device evaluated against technical standards, there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, there is no information on how its ground truth was established.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.