(14 days)
TELECTRODE Wet gel ECG Electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring.
The intended patient population can be adult and pediatric, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).
TELECTRODE Wet gel ECG Electrodes are a single use, self-adhesive, non-sterile, disposable ECG electrode that 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. The sensor is made of ABS plastic that has a Silver / Silver Chloride coating. The lead wire, cable and processor are not included with this device so the type of leadwire, cable and connector are not applicable.
The provided text describes the "Telectrode Wet-gel ECG Electrodes" device and its substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets specific acceptance criteria in the way described in your prompt (e.g., performance metrics, sample sizes for test/training sets, expert involvement, etc., which are typical for AI/ML-based device evaluations).
This document is a 510(k) summary for a Class II medical device (ECG electrodes), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel performance study against acceptance criteria in the context of an AI/ML system.
The "acceptance criteria" discussed are primarily regulatory standards for this type of device, not performance benchmarks of an AI algorithm.
Here's a breakdown of what is available from the text, framed to best answer your request, along with clear indications of what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|
| ANSI/AAMI EC-12 2000 (Electrical Performance) | "Pass" |
| ISO 10993-1 (Biocompatibility) | Met (materials selected and tested to demonstrate appropriate levels of biocompatibility) |
| Shelf Life | Ensures 24-month shelf life |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing is for a physical medical device (electrodes), and the testing described (ANSI/AAMI EC-12 and ISO 10993) refers to product testing, not performance evaluation on a "test set" of data in the AI/ML sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. "Ground truth" in the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for the regulatory submission of an ECG electrode. The "ground truth" for the performance claims here would be the physical measurements and observations made during the standard compliance testing.
4. Adjudication Method
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among experts during the establishment of ground truth in diagnostic studies, which is not what is being described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done or at least not described in this document. This type of study is specifically relevant for evaluating the impact of AI on human reader performance, which is not the focus of this device's submission.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done or at least not described in this document. This device is a physical electrode, not an algorithm. Therefore, "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
The "ground truth" used for this device's evaluation is based on objective measurements from standardized physical and biological tests (e.g., electrical measurements conforming to ANSI/AAMI EC-12 and biological responses conforming to ISO 10993-1). It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this device.
Summary regarding the "Study that Proves the Device Meets the Acceptance Criteria":
The document indicates that the device's electrical performance was proven to meet the acceptance criteria by passing the ANSI/AAMI EC-12 2000 standard. Biocompatibility was proven to meet acceptance criteria by selecting materials and conducting tests in accordance with ISO 10993-1. The shelf life was proven to ensure 24 months. These "studies" are standard product testing protocols rather than clinical trials or AI performance evaluations. The document does not provide details on the specific methodology, sample sizes of test articles, or results of these tests beyond stating that the device "passed" or "met" the requirements.
§ 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.