(89 days)
The Enfant is a non-invasive medical device to screen, without dilation or sedation, for visual disorders in infants and pre-school children. The system uses Visual Evoked potentials to provide information about the visual pathway function and about optical or neural abnormalities related to vision.
Horizontal Contrast Photopic stimuli are presented to the patient on a computer monitor at various numbers of elements in separately stimulated fields. The fields are varied in spatial size over a number of cycles. The signals are analyzed by the software using algorithms for spatial filtering and artifact rejection. Data may be presented in number form and on a graph. The device also adds some attention features specifically for children. In particular, a cartoon is presented prior to the VEP pattern. During the Cartoon presentation no data is collected. Age appropriate music is also presented to patient as well. The music is only intended as an attention facilitator.
The Enfant™ System is a non-invasive medical device designed to screen for visual disorders in infants and pre-school children without requiring dilation or sedation. It uses Visual Evoked Potentials (VEP) to assess visual pathway function and identify optical or neural abnormalities related to vision.
Here's an analysis of its acceptance criteria and the supporting study:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (like minimum sensitivity, specificity, etc.) for marketing authorization. However, the clinical performance study itself establishes the device's measured effectiveness, which implicitly served as the basis for substantial equivalence with predicate devices.
| Metric | Reported Device Performance (Enfant™) |
|---|---|
| Sensitivity | 0.973 |
| Specificity | 0.808 |
| Positive Predictive Value | 0.706 |
| Negative Predictive Value | 0.984 |
| Test Completion Rate | 94% |
| Average Time to Complete Testing (both eyes) |
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).