(139 days)
The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery.
The Natus Quantum Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.
The Natus Quantum amplifier is comprised of a base unit and several breakout boxes. It is part of a system that is made up of a personal computer, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports. The amplifier also contains an internal switch matrix to allow for a connection to an external cortical stimulator.
EEG and other physiological signals, from scalp electrodes, grid or needle electrodes, and other accessories such as pulse oximeters can be acquired by the Natus Quantum amplifier. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote networked storage for later review.
The provided text describes the Natus Quantum Amplifier, an electroencephalograph, and its regulatory submission (K143440). However, the document does not contain a study that directly proves the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or accuracy.
The document focuses on demonstrating substantial equivalence to predicate devices (EMU128S and NeuroLink IP 256) primarily through technical specifications and compliance with various safety, EMC, and quality standards. The "Performance Tests" section is very brief and refers to non-clinical verification testing rather than clinical efficacy studies.
Therefore, the following information is based on what is available or can be inferred from the provided text. Many requested fields will be marked as "Not Applicable" or "Not Provided" because the document does not describe the kind of clinical study you're asking about.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from a clinical study perspective) | Reported Device Performance (from the document) |
|---|---|
| Clinical performance metrics (e.g., sensitivity, specificity, accuracy in detecting electrophysiological signals) | Not provided. The document focuses on technical specifications and functional verification. |
| Technical Specifications (Comparison to Predicate Devices): | |
| EEG Channels | 64-256 (Subject Device, Predicate NeuroLink IP); 128 (Predicate EMU128S) |
| Reference Channels | Dedicated separate reference and ground (All devices) |
| Input Impedance | >1000 MOhm (Subject Device); >100 MOhms (Predicate NeuroLink IP); >47 MOhms (Predicate EMU128S) |
| Input Noise | 110dB@60Hz (Subject Device, Predicate EMU128S); >40dB@60Hz (Predicate NeuroLink IP) |
| Sampling Frequency | 256, 512, 1024, 2048, 4096, 8192, 16384 Hz (Subject Device); 256, 512, 1024 Hz (Predicate NeuroLink IP); 256, 512, 1024, 2048 Hz (Predicate EMU128S) |
| Sampling Resolution - EEG channels | 24 bits (Subject Device); 16 bits (Predicate NeuroLink IP); 22 bits (Predicate EMU128S) |
| Sampling Quantization - EEG channels | 305nV (Subject Device); 179 nV (Predicate NeuroLink IP); 310 nV (Predicate EMU128S) |
| Storage Resolution - EEG Channels | 16 bits (All devices) |
| Functional / Design Verification Tests: | |
| Signal Quality Verification Test | Pass |
| Functionality Verification Test | Pass |
Note on Acceptance Criteria: The document implies that meeting the specified technical characteristics that are substantially equivalent or superior to the predicate devices, and passing internal design verification tests, are the "acceptance criteria" for regulatory clearance based on substantial equivalence. It does not provide clinical acceptance criteria.
2. Sample size used for the test set and the data provenance
- Sample Size: Not Applicable. The document describes non-clinical verification testing of the device hardware/software, not a clinical study on patient data.
- Data Provenance: Not Applicable. No patient data was used for the described performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Applicable. Ground truth for clinical data is not relevant to the described non-clinical verification tests.
- Qualifications of Experts: Not Applicable.
4. Adjudication method for the test set
- Adjudication Method: Not Applicable. No clinical test set requiring adjudication was 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
- MRMC Study: No. This document describes an EEG amplifier, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not Applicable. This is a hardware device (EEG amplifier) with associated software for data acquisition, display, storage, and archiving. It is not an algorithm for standalone diagnostic performance.
7. The type of ground truth used
- Type of Ground Truth: For the "Performance Tests" (Signal Quality Verification Test, Functionality Verification Test), the ground truth would be the design specifications and expected operational parameters of the device. These tests verify if the actual output matches the designed output. No clinical "ground truth" (e.g., pathology, outcomes data) for diagnosis is mentioned for these tests.
8. The sample size for the training set
- Sample Size: Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not Applicable. (See 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).