(191 days)
The HMicro Wired C-Patch ECG Electrode is a single patient use, disposable, radiolucent wired ECG electrode with a silver/silver chloride sensing element designed for short-term, adult ECG monitoring at rest. It is designed to provide a single patch alternative to distributed electrodes. It has been tested using the GE Marquette Eagle 4000 ECG monitor and patient cable and should be used with monitors with equivalent or better sensitivity.
The HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available to place the patch.
The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on the left upper chest or center chest and used for ECG monitoring. It is disposable and single use. It has five pre-wired electrodes affixed to a 3-inch silicone patch, where wires from the electrodes are pulled through the silicone patch for connecting into the patient monitoring cable.
Here's the information about the acceptance criteria and the study for the HMicro Wired C-Patch Electrode, extracted from the provided text:
Acceptance Criteria and Device Performance Study for HMicro Wired C-Patch Electrode
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to provide usable ECG tracings as often as a commercially available predicate. | 85% (11/13) of volunteer data was similar between the two HMicro Patches (left chest and center chest placements) and the respective control (3M Red Dot electrodes). |
2. Sample size used for the test set and the data provenance
- Sample Size: 15 volunteers (netting usable ECG tracings data from 13 volunteers).
- Data Provenance: The document does not explicitly state the country of origin. It was an engineering study involving volunteers, implying a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a ground truth or their qualifications. The study focused on the usability of data by comparing ECG tracings from the subject device to a predicate device.
4. Adjudication method for the test set
The document does not describe an adjudication method involving experts for the test set. The comparison appears to have been based on similarity of ECG tracings.
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 conducted. This device is an electrode, not an AI-powered diagnostic system, so the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is an ECG electrode, not an algorithm. The study evaluated the ability of the electrode to produce usable ECG data.
7. The type of ground truth used
The "ground truth" in this context was established by:
- Comparison to a predicate device: The 3M Red Dot electrodes, a commercially available and legally marketed device, served as the comparative standard.
- Usable ECG tracings: The primary outcome measured was the similarity of the ECG tracings produced by the HMicro C-Patch to those from the predicate device.
8. The sample size for the training set
This is not applicable. The device is hardware (an ECG electrode), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this 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.