(87 days)
The ORI F6T Dry ECG Monitoring Electrodes are intended for use in adults (persons 18 years and older) in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrodes can be used in short term and long term (up to 2 days) ECG monitoring.
The ORI F6T Dry ECG Monitoring Electrode is a non-sterile, single-use, disposable electrode system consisting of a solid, Ag/AgCl-coated conductive polymer element with a mechanical skin interface surface designed to ensure adequate skin interface without the use of a component electrolytic gel. The conductive polymer clement is held in place using a novel adhesive tape patch.
The provided text describes the acceptance criteria and the study conducted for the ORI F6T Dry ECG Monitoring Electrode. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Performance: Meets applicable requirements of ANSI/AAMI EC 12:2000, Disposable ECG Electrodes. | Determined to meet the applicable requirements of ANSI/AAMI EC 12:2000. |
| Biological Safety: Assessed in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. | Biological safety assessed through tests specified in ISO 10993-1. |
| Clinical Performance: Substantially equivalent to predicate device as assessed in clinical testing conducted in accordance with ANSI/AAMI EC 12:2000 and FDA's ECG Electrode 510(k) guidance document. | Performance of the device was substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions "clinical testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance and equivalence of the device to predicate devices, not on human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was done for the device. The "electrical performance of the F6T Electrode was assessed and determined to meet the applicable requirements of ANSI/AAMI EC 12:2000, Disposable ECG Electrodes." This implies testing the device's inherent electrical capabilities without human interpretation or intervention beyond standard usage.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the electrical performance and biological safety was established by adherence to industry standards (ANSI/AAMI EC 12:2000 for electrical, ISO 10993-1 for biological safety). For clinical performance, the ground truth was based on comparison to a predicate device. This means the device's output was compared against the known performance of an existing, legally marketed ECG electrode.
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning or AI. The device is an ECG electrode, and its performance is evaluated based on standard engineering and clinical testing protocols, not through machine learning models requiring training data.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning for this device, this question is not applicable. The device's performance is validated against established industry standards and predicate device performance.
§ 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.