(77 days)
The CATS Tonometer™ Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure.
The CATS Tonometer™ Prism is used as an optical image prism for Goldmann applanation style tonometers. It is a modification of the standard Goldmann Applanation Tonometer (GAT) prism, with the only alteration being the modification of the flat surface in the GAT to a curved surface and a compensatory lengthening in the CATS prism. The CATS prism is made of PMMA, the corneal contact diameter is 7 mm and the total length of the prism is 30 mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CATS Tonometer™ Prism:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Success Criteria for Primary Endpoint) | Reported Device Performance |
|---|---|
| CATS tonometer prism measurements to be within ± 5 mmHg of the GAT tonometer prism measurements. | "No statistically significant difference in IOP measurement was observed between the CATS tonometer prism and the reference GAT tonometer prism." |
| No more than 5% of the paired differences between the reference tonometer (CATS prism) and the test tonometer (GAT prism) readings for each pressure range, would be greater than the tolerance levels: |
- 7 to 16 mmHg: ±5
-
16 to
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.