(147 days)
Paceart Wrist Electrodes are intended to be used for home monitoring of pacemaker patients via telephone monitoring systems.
Paceart Wrist Electrodes are metallic electrodes with elastic wristbands intended for electrocardiographic monitoring. Physically the device consists of a flat metallic electrode fastened to a familiar metallic expansion band of the type commonly used with wrist watches. Ordinarily, the patient would have one electrode and band on each wrist. Each electrode has attached to it a single cable, attached to a connector with an oversized pin. The cable is used to provide the connection to the monitor. No gel or other skin preparation is indicated, and in general is not necessary: the patient slips on the bracelet so that the electrode is on the inside of the wrist, and connects the cable connector to a jack on the monitor. The plug is of sufficiently large diameter so that it will not fit into a power outlet. The wrist electrode is used for home telephonic monitoring purposes, and in general will be in contact with the skin for a maximum of five minutes; it is not intended for use as a general-purpose electrocardiographic electrode or for long-term monitoring.
Here's a breakdown of the acceptance criteria and study information for the Paceart Wrist Electrodes, based on the provided text:
Paceart Wrist Electrodes: Acceptance Criteria and Study Details
The provided submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining specific numerical acceptance criteria for novel performance. The "acceptance criteria" are implied by showing the Paceart device performs equivalently or better than the predicate device and meets relevant AAMI standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Paceart Wrist Electrodes Performance | Reference |
|---|---|---|---|
| Noise | Equivalent to Medtronic 9427 Wrist Electrode; Better than AAMI EC12-1991 standard. | Values are equivalent to the predicate device. Better than AAMI requirements for reusable electrodes. | {1}, {5} |
| Offset Voltage | Equivalent to Medtronic 9427 Wrist Electrode; Better than AAMI EC12-1991 standard. | Values are equivalent to the predicate device. Lower offset voltage without gel than Medtronic electrodes. Better than AAMI requirements for reusable electrodes. | {1}, {5} |
| Biocompatibility | No adverse biological reaction; Use of accepted material (Type 304 Stainless Steel). | Manufactured from biologically-compatible Type 304 stainless steel. Considered biologically inert. | {1}, {4} |
| ECG Signal Quality | Produce virtually identical ECG recordings compared to the predicate device. | ECG recordings using Paceart electrodes were virtually identical to those from Medtronic electrodes. | {5} |
| Safety (Electrical) | Pin diameter too large to fit into a power outlet. | Pin has a 3.5 mm diameter, which is too large to fit into a power outlet. | {3}, {4} |
| Ease of Use | Easily attached with a minimum of adjustment and preparation (for elderly users). | Patient slips on the bracelet; no gel or skin preparation necessary. | {0}, {3} |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "human subject" (singular) for the clinical comparison, suggesting a very small sample, possibly a single individual or a small, unspecified number.
- Data Provenance: The study was a "Clinical Comparison" with human subjects. The country of origin is not specified but implicitly in the context of a US 510(k) submission, it would often be the US. The study was prospective in nature, as it involved actively conducting tests with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" here is the recorded ECG signal and the physical characteristics/measurements. There were no human expert interpretations requiring consensus to establish ground truth for this device's performance. The comparison was directly between the output of the device and a predicate, and against established engineering standards.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison of physical and electrical properties, not an interpretative task requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study focused on the physical and electrical performance of the device itself, not on the improvement of human readers with or without AI assistance. This device is not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the bench tests for noise and offset voltage, as well as the biocompatibility assessment, represent standalone performance evaluations of the device's physical and electrical characteristics. The "Clinical Comparison" also evaluated the device's ability to record an ECG signal on its own, for direct comparison to a predicate, which also functions as a standalone assessment.
7. The Type of Ground Truth Used
- Bench Tests (Noise & Offset Voltage): The ground truth was established by direct physical measurement according to AAMI standard EC12-1991, Paragraph 4.2.2.3 and 4.2.2.2.
- Biocompatibility: The ground truth was established by material specification (Type 304 Stainless Steel is "biologically inert") and its historical use.
- Clinical Comparison (ECG Signal Quality): The ground truth was the ECG signal generated simultaneously by the predicate device, against which the Paceart device was compared for "virtually identical" results.
8. The Sample Size for the Training Set
Not applicable. This device is a passive medical component (electrodes), not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
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.