(90 days)
The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.
The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages. The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K180269) with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices. Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.
The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML powered device. The document is a 510(k) premarket notification for the Cadwell Apollo System, an electroencephalograph, and focuses on demonstrating substantial equivalence to a predicate device through engineering and software testing for safety and performance against established standards.
Therefore, the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML component cannot be extracted from this document. The document describes traditional device testing, not AI/ML model validation.
§ 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).