(309 days)
The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG electrodes are 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 electrodes are for single patient use only.
Ambu® Blue Sensor NEO/NEO X is non-sterile, self-adhesive ECG electrodes. Ambu® Blue Sensor NEO/NEO X should only be used by or on the order of a physician. Ambu® Blue Sensor NEO/NEO X is single patient use disposable devices. Ambu® Blue Sensor NEO/NEO X is a multi-layer construction containing a pre-attached lead wire with an attached connector, a top disc, a top film, a sensor and a hydrogel adhesive.
The provided text describes the 510(k) summary for the Ambu® Blue Sensor NEO/NEO X disposable ECG electrodes. Here's a breakdown of the acceptance criteria and study information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical and mechanical functionality required by ANSI/AAMI EC12:2000 - Disposable ECG Electrodes | The Ambu® Blue Sensor NEO/NEO X meets the mandatory performance standard requirements under ANSI/AAMI EC12:2000. |
| Biocompatibility as per ISO 10993-1 – Biological evaluation of Medical Devices | The biological safety of the Ambu® Blue Sensor NEO/NEO X has been assured through the selection of materials demonstrating appropriate levels of biocompatibility. The biocompatibility has been established. |
| Equivalent electrical and mechanical functionality to predicate devices (Ambu® Blue Sensor NF and Ambu® Blue Sensor BRS) | Aging tests and comparison tests to predicate devices were performed, concluding that the Ambu® Blue Sensor NEO/NEO X has equivalent electrical and mechanical functionality to the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of the number of electrodes or the duration of testing for the acceptance criteria outlined. It mentions "laboratory tests" and "aging test."
- Data Provenance: The tests conducted are non-clinical laboratory tests performed by the manufacturer, Ambu A/S, in Denmark. The data is prospective in the sense that it was generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a disposable ECG electrode, not an AI/software device that requires expert ground truth for interpretation of diagnostic images or signals. The "ground truth" for its performance is derived from compliance with engineering standards (ANSI/AAMI EC12:2000) and biocompatibility standards (ISO 10993-1).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As above, this is not an AI/software device requiring subjective interpretation or adjudication of results. Compliance with standards is objective.
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
- No, an MRMC comparative effectiveness study was not done. This is a hardware device (ECG electrode), not an AI assistance tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by engineering standards (ANSI/AAMI EC12:2000) for electrical and mechanical functionality and biocompatibility standards (ISO 10993-1) for material safety.
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As this is a hardware device, there is no "training set" in the context of machine learning.
§ 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.