(188 days)
The Qwiklead™ Electrocardiograph Electrode Patch is intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include, in particular, patient ECG surveillance and ECG diagnosis recording. The Qwiklead™ Electrocardiograph Electrode Patch is intended for single-patient/single application use and is intended to be used on intact (uninjured) skin. The Qwiklead™ Electrocardiograph Electrode Patch is to be used on adults.
The Qwiklead™ Electrocardiograph Electrode Patch configures pre-positioned ECG electrodes affixed to the underside of a single non-sterile, laminated, flexible patch/pad. The patch is a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate) including at least one electrode, a second layer (metallic with Ag/AgCl coating) that contains the electrodes, and a third layer (made of biocompatible conductive hydrogel coupling media). The patch is placed on the patient's chest, and no additional electrodes need be placed on the patient's limbs, as is typical for ECG electrodes.
The provided 510(k) summary for the Qwiklead™ Electrocardiograph Electrode Patch does not describe a study related to acceptance criteria for a device performance, multi-reader multi-case (MRMC) comparative effectiveness, or standalone algorithm performance in the way typically expected for AI-powered diagnostic devices. This submission pertains to an ECG electrode patch, which is a physical medical device, not a software algorithm or AI system.
Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, how ground truth for training was established) are not applicable to this type of device and are not present in the provided documentation.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on bench testing of physical and electrical properties, and biocompatibility.
Here's a breakdown of the information that is available or relevant to this type of device submission based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by recognized standards for ECG electrodes, and the device is reported to meet these.
| Acceptance Criteria (Standard) | Device Performance |
|---|---|
| ANSI/AAMI EC12:2000: | |
| AC impedance | Met specifications |
| DC offset voltage | Met specifications |
| Defibrillation overload recovery | Met specifications |
| Combined offset instability and internal noise | Met specifications |
| Bias current tolerance | Met specifications |
| ISO 10993-1 (for skin contact): | |
| Cytotoxicity | Passed |
| Sensitization | Passed |
| Primary skin irritation tests | Passed |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of an AI device. For this physical device, "test set" refers to the tested electrode patches. The quantity of patches tested is not specified, but it would have been a sample size sufficient to demonstrate compliance with the standards, likely from a production batch. The provenance of material testing data is generally from the manufacturer's internal testing or a certified lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in this context refers to the defined specifications in the ANSI/AAMI and ISO standards, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
Not applicable. Testing involves quantitative measurements against predefined thresholds in standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is typically for evaluating diagnostic accuracy of interpretations (e.g., by human readers, or humans assisted by AI) on a collection of cases, which is not relevant for an ECG electrode patch itself.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an electrode patch, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation against its acceptance criteria is defined by recognized international standards:
- ANSI/AAMI EC12:2000 for electrical performance of disposable ECG electrodes.
- ISO 10993-1 for biocompatibility (skin contact).
These standards set the objective, measurable parameters and thresholds that the device must meet.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for an ECG electrode patch as it does not involve machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.