(86 days)
The Neuroscan Nuamps® system is intended for the measuring, recording and analysis of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG. The system is intended for the EEG and long/middle-latency EP registration in the research environment.
The Neuroscan Nuamps® is a 40-channel EEG amplifier capable of direct current (DC) recording, including signal amplification, analog-to-digital conversion, and filtering. Nuamps® permits high-speed simultaneous sampling, acquisition and transfer of data host computer that controls, displays, and stores the acquired data. Nuamps®'s software routines separately control each channel and perform real-time digital filtering. Nuamps® software measures and analyzes EEG signals and performs analysis of complete data sets, calculates compressed spectrum arrays (CSA), and presents results as annotated signal plots or topographic/tomographic maps in real-time two or three-dimensional (2/3-D) context. Nuamps® is optically isolated and transformers are available for line voltages of 100, 120, 230, VAC.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Neuroscan Nuamps® device:
Based on the provided text, the device is an Electroencephalograph (EEG) system, and the submission is a 510(k) premarket notification. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through rigorous clinical trials with specific acceptance criteria in the same way a PMA device would.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to compliance with applicable standards and performance equivalent to the predicate device, demonstrated through non-clinical testing. The text does not describe a study involving human subjects, AI performance, or the establishment of ground truth in the traditional sense for diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Compliance/Equivalence) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) and related collateral/particular standards. | "All tests were completed satisfactorily without adverse report." |
| Compliance with EN46001 / EN ISO9001:2000 (Quality systems - Medical devices) | "All tests were completed satisfactorily without adverse report." |
| Compliance with MDD 93/42/EEC (Medical Device Directive) | "All tests were completed satisfactorily without adverse report." |
| Compliance with AAMI EC53-1995 (Standard for Ambulatory Electrocardiographs) - Note: Though context is EEG, this standard is listed. | "All tests were completed satisfactorily without adverse report." |
| Compliance with CDRH Guidance Document on the "Performance Standard for Electrode Lead Wire and Patient Cables," March 9, 1998. | "All tests were completed satisfactorily without adverse report." |
| Functional equivalence to the predicate device, Neuroscan SCAN LT (K001564), in terms of safety and effectiveness for EEG measurement, recording, and analysis. | "The Neuroscan Nuamps® systems works in the same manner as the approved and predicate device," and "demonstrate that the performance of the system is equivalent to that of the predicate devices in the terms of safety and effectiveness." |
| Additional features (12-bit trigger board for timing information) provide utility and product performance exceeding the predicate device. | "additional features provide utility and product performance which exceed that of the predicate devices." |
| Electrical activity measurement, recording, and analysis for monitoring and diagnosis in clinical EEG settings. | "intended for the measuring, recording and analysis of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG." |
| EEG and long/middle-latency EP registration in the research environment. | "The system is intended for the EEG and long/middle-latency EP registration in the research environment." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a test set or data provenance in the context of diagnostic accuracy where a "sample size" of patient data would be relevant. The testing performed was related to engineering and regulatory compliance standards for electrical safety and functional equivalence, not a clinical study on a patient cohort.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided as the submission describes an EEG hardware and software system, not an AI or diagnostic algorithm requiring expert-established ground truth for a test set. The validation focused on technical performance and safety standards.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The document describes a 510(k) submission for an EEG device, focusing on its technical specifications, compliance with standards, and equivalence to a predicate device. It does not involve human readers interpreting cases or AI assistance to human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable as the device is an EEG system for measuring, recording, and analyzing electrical brain activity, not a standalone diagnostic algorithm that operates without human clinician involvement. While it has "software routines" that "measure and analyze EEG signals," this is part of a standard EEG system, not an AI algorithm designed to operate independently for diagnosis without human oversight or interpretation of the generated data.
7. The Type of Ground Truth Used
The concept of "ground truth" (e.g., pathology, outcomes data) as typically applied to diagnostic AI devices is not relevant or described in this 510(k) summary. The "truth" for this device's performance is compliance with electrical and medical device safety standards, and functional specifications equivalent to a predicate EEG device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is an EEG hardware and software system, not a machine learning model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
§ 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).