(50 days)
The CATS-L® Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.
The CATS-L Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. The CATS-L prism is made of PMMA, the corneal contact diameter is 6.28 mm, and the total length of the prism is 29.28 mm.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Area of Applanation | ANSI Z80.10-2018 A1.1 | Diameter of $3.06 \pm 0.02$ mm | Met acceptance criteria |
| Surface of Pressure Body – surface imperfections | ANSI Z80.10-2018 A1.2 | Free from surface imperfections that could damage the eye | Met acceptance criteria |
| Surface of Pressure Body – Diameter | ANSI Z80.10-2018 A1.2 | Diameter minimum of 6.0 mm | Met acceptance criteria |
| Surface of Pressure Body – Flatness | ANSI Z80.10-2018 A1.6 | Flat with a tolerance of 10 or fewer fringes over the 4-mm central diameter | Met acceptance criteria |
2. Sample size used for the test set and the data provenance:
- Sample Size: Five samples of the CATS-L tonometer prisms were evaluated.
- Data Provenance: The document does not specify the country of origin. The study is described as "design verification bench testing," implying a prospective, controlled laboratory setting rather than retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described is bench testing against specified engineering standards, not a clinical study involving human experts establishing ground truth from patient data.
4. Adjudication method for the test set:
This information is not applicable as the testing was bench testing against engineering standards, not a clinical study requiring expert adjudication of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a tonometer prism, which is a physical accessory for measuring intraocular pressure, not an AI or imaging diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone performance study of an algorithm was not done. This device is a physical medical device accessory, not a software algorithm. The "performance data" refers to bench testing of the physical properties against engineering standards.
7. The type of ground truth used:
The ground truth used was based on engineering standards specified in ANSI Z80.10-2018. Specifically, sections A1.1, A1.2, and A1.6 for various physical and optical properties of the tonometer prism.
8. The sample size for the training set:
This information is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
§ 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.