(30 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 New Yorks™ 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 monits, 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 the front end hardware of an electroencephalograph, and consists of amplifier circuitry, A/D Converters, Digital Signal Processing, digital switch matrix, LCD touch screen interface as well as TCP/IP & USB connection options of PC communication.
The Natus Quantum Amplifier can record either in Tethered mode or in Ambulatory Mode. In Ambulatory Mode, data is stored in the Quantum Breakout's internal memory and automatically uploaded to the main study folder when the Quantum Breakout is reconnected to the Natus Base unit.
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 by an external cortical stimulator.
The provided text describes the 510(k) summary for the Natus Quantum, an electroencephalograph (EEG) device. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, intended use, and adherence to various safety and performance standards.
However, the document does not contain information about the development and testing of a medical device that uses artificial intelligence (AI) or machine learning. Therefore, it does not provide details for the following requested information:
- A table of acceptance criteria and the reported device performance: The document lists various technical specifications (e.g., input impedance, input noise, sampling frequency) for the device and its predicate, along with general statements about compliance with standards (e.g., "Results indicate that the Natus Quantum complies with the applicable standards"). It does not outline specific acceptance criteria in the format of a table with numerical performance results directly tied to those criteria, especially not in the context of an AI/ML algorithm's performance.
- Sample size used for the test set and the data provenance: No data sets for AI/ML model testing are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no mention of a ground truth for an AI/ML component.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance (as present in the document):
The document provides a "Summary of Performance Testing" for the Natus Quantum, focusing on:
- Software: "The Natus Quantum firmware was designed and developed according to a robust software development process, and was rigorously verified and validated." It states that the firmware complies with predetermined specifications and applicable guidance documents/standards (e.g., "The content of premarket submissions for software contained in medical devices, IEC 62304: 2006").
- Electrical Safety: "The Natus Quantum was verified for performance in accordance with the following standard: IEC 60601-1: 2005, Am1: 2012." It concludes that the device "complies with the applicable standards."
- Electromagnetic Compatibility: "The Natus Quantum was verified for performance in accordance with the following standard: IEC 60601-1-2 Edition 4.0 2014-02." It concludes that the device "complies with the applicable standards."
In essence, this 510(k) pertains to a traditional medical device (an EEG amplifier) and its compliance with established electrical and software engineering standards, not the performance evaluation of an AI-powered diagnostic or assistive tool.
§ 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).