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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:

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.

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The CATS®-D Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.

The CATS®-D Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. It is made of PMMA, the corneal contact diameter is 6.5 mm and the total length of the prism is 30 mm.

This document does not contain information related to AI/ML device performance or clinical studies typical for AI/ML-based medical devices. The submission (K203850) is for a CATS®-D Tonometer Prism, which is a physical accessory for Goldmann type tonometers, not an AI/ML algorithm.

The core of the submission focuses on demonstrating substantial equivalence to a predicate device (CATS® Reusable Tonometer prism K173904) through performance data related to:

• Design verification: Ensuring the device meets its design specifications.
• Sterilization validation and shelf-life testing: Confirming the sterility and stability of the disposable prism.
• Biocompatibility testing: Cytotoxicity, sensitization, and irritation tests according to ISO 10993 standards.

There is no mention of:

• Acceptance criteria for an algorithm's performance (e.g., accuracy, sensitivity, specificity).
• A test set with ground truth or expert annotations.
• Sample sizes for AI/ML model testing or training.
• The number or qualifications of experts.
• MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.

Therefore, I cannot provide a response to the prompt's specific requirements, as they are geared towards AI/ML device evaluations, which are not relevant to this 510(k) submission.

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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

• 7 to 16 mmHg: ±5

• 16 to

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