(117 days)
The CVA-1000 is intended for use under the direct supervision of an ophthalmologist or optometrist in the measurement of vision at fixation in one or both eyes, with or without optical correction.
The CVA-1000 instrument is a standalone device consisting of a computer processing unit with data storage, two LCD monitors, a physician viewed monitor and a patient viewed monitor, and connected keyboard and mouse for physician interaction with a response pad for patient interaction. The instrument provides an evaluation of vision at fixation of one or both eyes under different conditions of contrast and lighting assisting the ophthalmologist or optometrist in evaluating the effects of prescribed refractive instruments such as spectacles or contact lenses and of pharmaceutical treatment or surgical procedures on the central vision of one or both eyes.
The instrument may be used in either of two methods of operation: Chart Panel or Interactive Central Vision Panel.
Here's a breakdown of the acceptance criteria and the study details for the Vimetrics Central Vision Analyzer 1000 (CVA-1000), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pearson correlation coefficient between CVA-1000 modules and corresponding logMAR chart > 0.8. | All but one CVA module (98% black Landolt C's against a bright white background) had a Pearson correlation coefficient > 0.8. The excepted module still showed a correlation > 0.5. All correlations were statistically significant (p |
§ 886.1150 Visual acuity chart.
(a)
Identification. A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.