(189 days)
The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
The Quick-20m is a wireless, battery-operated 10-20 montage EEG headset utilizing dry sensor technology. The headset provides an integrated approach to the wireless acquisition of EEG signals. A seated patient is free to exhibit natural movements while real-time data is collected. The Quick-20m includes advanced amplification and shielding to reject ambient electrical noise.
The headset obtains high-quality EEG with minimal scalp preparation. Patented mechanisms and a range of replaceable dry sensors align to various head shapes and sizes, maintaining sensor positions in a standard 10-20 layout. EEG channels are digitized with 24 bits of resolution at 500 Hz. The Quick-20m is suitable for general-purpose EEG.
Regrettably, the provided text does not contain the information needed to answer your request about acceptance criteria and the study proving the device meets them.
The document is a 510(k) premarket notification letter and summary for a device called "Quick-20m," which is a physiological signal amplifier (EEG headset). While it discusses the device's technical characteristics and claims substantial equivalence to a predicate device (g.Nautilus PRO), it explicitly states the following:
- "Clinical studies were not required to demonstrate that this device is as effective and at least as safe as the predicate device." (page 10)
- "Bench testing on the Quick-20m includes Intertek certifications to 80601-2-26. in addition to internal company design verification testing that successfully demonstrated compliance to user inputs, and in accordance with 21 CFR 820.40. Clinical testing on the Quick-20m was not applicable." (page 10)
This submission relies on technical comparisons to a predicate device and bench testing for safety standards rather than a clinical study or performance data against specific acceptance criteria for a diagnostic/interpretive AI.
Therefore, I cannot extract:
- A table of acceptance criteria and reported device performance: No such criteria or performance data are presented.
- Sample size for the test set and data provenance: No test set is described.
- Number of experts and their qualifications for ground truth: No expert ground truth establishment is described as clinical studies were not performed.
- Adjudication method for the test set: Not applicable as there's no test set.
- MRMC comparative effectiveness study or effect size: No clinical study involving human readers or AI assistance is mentioned.
- Standalone (algorithm only) performance: The device is a hardware amplifier; performance here refers to its ability to acquire and transmit EEG, not an AI algorithm's diagnostic performance.
- Type of ground truth: Not applicable as no clinical ground truth was established for performance evaluation.
- Sample size for training set: Not applicable; this is a hardware device, not an AI model requiring a training set in the conventional sense.
- How ground truth for training set was established: Not applicable.
The document focuses on establishing substantial equivalence based on technical specifications and safety standards, not on a performance study against specific diagnostic or interpretive endpoints.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).