(327 days)
ECG monitoring electrodes for short-term use.
Pregelled electrodes are of Aq/AqCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
The provided text is a 510(k) summary for the Niko ECG Monitoring Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and specific performance metrics for the new device.
Therefore, the document does not contain the information required to populate the table of acceptance criteria and device performance or to describe a study proving the device meets those criteria, as typically understood for a new product performance study.
Specifically, the text states: "The Niko ECG Monitoring Electrodes are identical in composition, function and design, and have the same intended use as the legally marketed disposable ECG monitoring electrodes... Accordingly Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models... are safe and effective for their intended use and perform at least as well as other disposable ECG monitoring electrodes."
This is a statement of self-assessment based on identity to predicate devices, not a study performing specific tests against predetermined acceptance criteria.
To address the prompt as accurately as possible given the provided text, I will state that the product is claiming substantial equivalence to predicate devices, rather than establishing new performance criteria.
Here's a breakdown of what can and cannot be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or reported performance metrics for the Niko ECG Monitoring Electrodes in a study. It asserts that the device is "identical in composition, function and design" to predicate devices and therefore "perform at least as well."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or study is described for the Niko ECG Monitoring Electrodes. The claim is based on substantial equivalence to existing predicate devices.
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)
- Cannot be provided. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is described.
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
- Cannot be provided. This is not an AI device, and no MRMC study or comparative effectiveness study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not an AI algorithm; it is an electrode. No standalone performance study is mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth is established for the Niko ECG Monitoring Electrodes as no distinct performance study is detailed.
8. The sample size for the training set
- Cannot be provided. This is not a machine learning device, and no training set is mentioned.
9. How the ground truth for the training set was established
- Cannot be provided. This is not a machine learning device, and no training set or its ground truth establishment is mentioned.
Summary based on the provided text:
The submission K990113 for the Niko ECG Monitoring Electrodes does not involve a study to prove the device meets specific acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The core argument is that the Niko ECG Monitoring Electrodes are "identical in composition, function and design" and have "the same intended use" as several legally marketed predicate devices from Nikomed USA, Inc. Therefore, the conclusion is that the Niko electrodes "perform at least as well as other disposable ECG monitoring electrodes."
No specific quantitative acceptance criteria, performance data, test sets, expert reviews, ground truth establishment, or training sets are described in the provided sections of the 510(k) summary. This type of 510(k) submission typically leverages existing data and regulatory approvals of the predicate devices.
§ 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.