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510(k) Data Aggregation
(141 days)
The AURIS I and AURIS II ABR Systems provide information regarding the functional integrity of the peripheral and central auditory system. It tests for auditory evoked potentials as an aid in detecting hearing loss and lesions in auditory pathways. It is ittended for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.
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The provided text does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Auris AEP" (later referred to as "AURIS I and AURIS II ABR Systems"). It establishes substantial equivalence to a predicate device and outlines regulatory guidelines.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
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(88 days)
The Ulmer Video Nystagmograph System is intended for use by the physician as an aid for the detection and diagnosis of vestibular disorders. The Ulmer VNG detects and displays eye position and movement in response to a number of vestibular stimulations, i.e. saccadic test, smooth pursuit, optokinetic nystagmus, caloric tests, and kinetic vestibular tests. The Ulmer VNG records and analyzes the bilateral, monocular, horizontal, and vertical aspects of eye position and movement. This device is intended to be used in a doctor's office or health care facility to obtain recorded data of nystagmus by directly observing eye motion by videocameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.
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I am sorry, but the provided text is a letter from the FDA to a medical device consultant regarding the clearance of a device. It does not contain information about the acceptance criteria, study details, or performance data of the "Synapsys Ulmer Video Nystagmograph". Therefore, I cannot generate the requested table and information based on this input.
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