(89 days)
Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.
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This is a 510(k) premarket notification for a medical device (Ambu Disposable ECG Electrode) and as such, it does not typically contain detailed studies with acceptance criteria and performance metrics in the same way a clinical trial report would for a novel device. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can extract the information that is present and explain why other information is not available.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document (510(k) summary) does not include a direct table of acceptance criteria and reported device performance for a study. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, which usually involves comparing design, materials, indications for use, and performance characteristics. The performance is typically demonstrated through bench testing and often, but not always, limited clinical testing, which are then compared to the predicate device's known performance. The specific performance data and criteria would be in the full submission, not usually in the publicly available summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided document. A 510(k) summary typically doesn't detail the sample size or provenance of specific test data unless it's a critical part of demonstrating substantial equivalence for a novel aspect. It's likely that a variety of bench tests were performed on a sample of electrodes, but specifics are not mentioned.
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)
Not applicable/available. For an ECG electrode, ground truth for performance is established through objective electrical and biocompatibility testing (e.g., impedance, adhesion, irritation) against established standards or predicate device performance, not typically by expert review of "truth" in the same way an imaging AI algorithm would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/available. Adjudication methods are typically used in studies where human interpretation of medical data is being evaluated, such as in imaging or clinical diagnoses. For an ECG electrode, objective test results are generally compared to pre-defined thresholds or predicate device results.
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
Not applicable. MRMC studies, especially those involving AI assistance, are relevant for diagnostic devices that interpret complex data, such as imaging. An ECG electrode is a passive measurement device; it doesn't "interpret" data in a way that would involve human readers or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm in the "Ambu Disposable ECG Electrode" to perform standalone analysis. It is a physical device used to acquire physiological signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for an ECG electrode would generally refer to specific performance metrics established through validated testing methods, such as:
- Electrical Performance: Impedance, DC offset, combined offset instability, defibrillation overload recovery (as per ANSI/AAMI EC12:2000 standard).
- Adhesion: Adhesion strength over time.
- Biocompatibility: Absence of cytotoxicity, irritation, sensitization (as per ISO 10993 standards).
These "ground truths" are verified through standardized bench tests and potentially limited human use studies for skin irritation, but not through expert consensus on diagnostic interpretation or pathology, as the device doesn't make a diagnosis. The document does not specify which of these were used or the details of the testing.
8. The sample size for the training set
Not applicable. This device does not use an algorithm that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.
§ 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.