(243 days)
The 3M Red Dot™ Resting EKG Electrode can be used on a patient undergoing an EKG diagnostic procedure while resting. These electrodes are applied to the patient's skin for short term use. These electrodes are disposable and are for single use. They are not indicated for use in long term monitoring.
3M Red Dot™ Resting EKG Electrode, Catalog Number 2360 has a conductive adhesive which is laminated to a conductive Ag/AgCl backing. The conductive backing has a tab end for connection to the electrocardiograph leadwire.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 3M Red Dot™ Resting EKG Electrode, 2360 (K974445):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Selection of materials which demonstrate appropriate levels of biocompatibility, based on ISO 10993-1, "Biological Evaluation of Medical Devices". |
| Electrical Performance | Meets the voluntary standard requirements under ANSI/AAMI EC12/1991, for Disposable ECG Electrodes. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing primarily focuses on the device's adherence to a recognized electrical performance standard (ANSI/AAMI EC12/1991) and biocompatibility standards, rather than a clinical ground truth established by medical experts for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. The performance testing described is likely based on objective measurements against a standard, not on subjective expert review requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document focuses on the device's technical specifications and adherence to standards, not on a clinical effectiveness study involving human readers or comparative analysis with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The described "Performance Testing" evaluates the electrical performance of the electrode itself, independent of a human operator's interpretation or involvement beyond setup. This is a standalone evaluation of the device's physical and electrical properties, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for performance assessment is based on voluntary standard requirements (ANSI/AAMI EC12/1991 for electrical performance) and biocompatibility standards (ISO 10993-1). These are established, objective measures against which the device's properties are compared.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (electrode) and not an AI/algorithmic device that would require a "training set" in the machine learning sense. The testing described is for physical and electrical performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.