(94 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 analyses 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 video cameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.
The Ulmer VNG is a video nystagmograph system composed by a software and hardware components.
The software has optional modules: Caloric, Saccade, Slow Pursuit, Kinetic, Optokinetic, Nystagmus (Nystagmus, Gaze or Vertical Subjective modules). It is provided on a CD Rom and activated with a key licensing.
The hardware components correspond to a video acquisition unit. The video acquisition unit is composed by different camera goggles/masks in order to allow the visualization of the movement of one or both eye of the patient. The types of cameras included are as follows:
- -Type VNS (goggle camera wired),
- -Type WNS (goggle camera wireless using Wifi), and
- -Type VISIO (goggle camera for visual free field).
For Kinetic Test, an optional stimulator system can be used and is composed by a speed sensor velocimeter and a rotating chair.
The modified Ulmer VNG system is a modification of the previously cleared Synapsys Ulmer VNG System (K982103) which allows use of a wireless camera (using Wifi).
The advantage of a wireless camera system resides in both ergonomics: manoeuvers made easier without being disturbed by cable presence; and portability: makes possible to bring a VNG system (PC laptop + wireless camera) to the patient unlike other fixed wired systems.
The provided document is a 510(k) Pre-market Notification for the Synapsys Ulmer Video Nystagmograph (VNG) system (K163558), specifically concerning a modification that allows for the use of a wireless camera. This document focuses on demonstrating substantial equivalence to a predicate device (K982103), rather than presenting a performance study with acceptance criteria for a new AI/algorithm-based device.
Therefore, the information required to answer the prompt regarding acceptance criteria and the study proving the device meets those criteria (especially for an AI/algorithm where detailed performance metrics, ground truth, and human reader studies would be relevant) is not present in this document.
The document states:
- "There was no human clinical testing required to support the medical device as the intended use is the same as the predicate device." (page 9)
- "The non-clinical testing detailed in this submission supports the substantial equivalence of the device." (page 9)
The non-clinical testing mentioned is primarily related to electrical safety, electromagnetic compatibility, and software verification to ensure that the integration of the wireless camera does not introduce new safety or effectiveness concerns. These are not performance metrics of an AI/algorithm, but rather engineering and regulatory compliance tests for the modified hardware component.
Given the absence of the requested data in the provided text, I cannot fill in the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/algorithm.
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).