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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.

AI/ML Overview

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 < 23 mmHg: ±5 - ≥23 mmHg: ±5	The document states that the study indicated the accuracy "met or exceeded the performance requirements of the reference GAT tonometer." While it doesn't explicitly state the percentage of measurements outside the tolerance, the claim of meeting or exceeding requirements, along with "no statistically significant difference" implies this criterion was met.
Intra-operator and inter-operator repeatability of the CATS Tonometer™ Prism compared to the GAT tonometer. (Implied: similar or better repeatability to GAT).	"The study indicated that the accuracy and both inter-operator as well as intra-operator repeatability met or exceeded the performance requirements of the reference GAT tonometer." "No statistically significant difference in IOP measurement repeatability was observed between the CATS tonometer prism and the reference GAT tonometer prism with respect to inter-operator, intra-operator, as well as lot repeatability."
Non-clinical design requirements articulated in ANSI Z80.10-2014.	"Design verification testing, which consisted of optical and mechanical tests, demonstrated that the CATS Tonometer™ Prism met the design requirements articulated in ANSI Z80.10-2014."
Bench testing in accordance with ANSI Z80.10 and FDA Guidance (March 27, 2006): Tonometers - Premarket Notification [510(k)] Submissions using human cadaver eyes.	"Bench testing was also performed in accordance with both ANSI Z80.10, Ophthalmic Instruments - Tonometers and FDA Guidance (March 27, 2006): Tonometers - Premarket Notification [510(k)] Submissions using human cadaver eyes."

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document mentions "adult population" for the clinical evaluation but does not specify the numerical sample size for the test set.
Data Provenance: The document does not specify the country of origin of the data. The study appears to be prospective as it describes a clinical evaluation conducted to compare the CATS Tonometer™ Prism against the GAT tonometer. There is also bench testing that used human cadaver eyes, which would be considered retrospective in a sense, but for a different type of evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish ground truth for the clinical test set or their qualifications. The ground truth appears to be the measurements from the predicate Goldmann Applanation Tonometer (GAT).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison is directly between the new device's readings and the predicate device's readings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The study focuses on the "inter-operator" and "intra-operator" repeatability of the device itself, implying different operators using the device, but not in an AI-assisted versus non-AI-assisted paradigm. The CATS Tonometer™ Prism is a physical accessory to a tonometer, not an AI algorithm.

6. Standalone (Algorithm Only) Performance

This question is not applicable as the CATS Tonometer™ Prism is a physical device (an optical image prism), not an algorithm or AI software. It does not have standalone algorithmic performance.

7. Type of Ground Truth Used

The ground truth for the clinical study was established by comparison to the measurements obtained from the legally marketed predicate device, the Goldmann Applanation Tonometer (GAT). This implies the GAT's readings were considered the reference standard for accuracy and repeatability.

8. Sample Size for the Training Set

This question is not applicable. The CATS Tonometer™ Prism is a physical medical device, not a machine learning model or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this physical device.

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