(182 days)
The NeuroPort™ NSP System is intended for temporary (
The Neuroport Neural Signal Processing (NSP) System is intended for recording and monitoring. Its functionality includes routine brain activity recording, monitoring, retrieval and replay. The Neuroport supports up to 96 channels of recording and is comprised of the following hardware components: Patient Cable, Amplifier, CPU and a Display monitor. The Neuroport System also includes the following software functions: acquisition, amplification and display.
This K042626 submission for the NeuroPort™ NSP System does not describe specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study with a test set, ground truth establishment, or clinical performance evaluation against such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (BMSI 5000 (Nicolet), Ceegraph (Bio-Logic), and EMU 128 (XLTek)) primarily through:
- Intended Use Comparison: Stating that the NeuroPort™ NSP System has similar indications for use (temporary recording and monitoring of brain electrical activity) as the predicate devices.
- Functionality Comparison: Asserting that the functionality (recording, amplification, digitization, monitoring, retrieval, display) is identical to the predicate devices.
- Compliance with Safety Standards: Listing compliance with relevant safety standards for intra-operative and hospital monitoring settings (IEC 60601-2-26, IEC 60601-1-2, UL 2601-1, CAN/CSA-C22.2 no. 601.1-M90).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, or comparative effectiveness studies, as these types of data were not presented in this 510(k) summary for the NeuroPort™ NSP System. The device's "performance data" as mentioned in the summary refers to its compliance with safety standards, not to the diagnostic or analytical performance often seen with AI/clinical decision support devices.
Since this device is a neural signal amplifier and not an AI-powered diagnostic tool, the typical AI study parameters (e.g., sample size for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance) are not applicable or reported in this 510(k) summary.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).