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The Canon FULL AUTO TONOMETER TX-F is intended to be used for the measurement of intraocular pressure of the human eye.

The Canon FULL AUTO TONOMETER TX-F is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure with the help of a full auto-alignment system.

This is a 510(k) premarket notification for a medical device submitted to the FDA. Such submissions focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a PMA (Pre-Market Approval) or de novo submission might for novel devices.

Therefore, the provided document does not contain the specific information requested in your prompt regarding acceptance criteria and a detailed study proving device performance as typically expected for advanced AI/ML models.

Here's a breakdown of why and what information can be inferred from the document:

Why the requested information is not present:

• Type of Device: The Canon FULL AUTO TONOMETER TX-F is a tonometer, a physical medical device for measuring intraocular pressure. It's not described as an AI/ML powered device or software.
• Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device (in this case, the Canon TX-10 Tonometer). This pathway generally focuses on comparing technical characteristics, materials, and intended use, rather than extensive clinical efficacy studies with predefined acceptance criteria for novel performance metrics.
• Date: The submission is from 2002, long before the widespread use and regulatory guidelines for AI/ML in medical devices became common.

Based on the provided text, the following specific questions cannot be answered:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance in the context of an algorithm.
• Type of ground truth used in the context of image interpretation or complex diagnostic algorithms.
• Sample size for the training set.
• How ground truth for the training set was established.

What can be extracted or inferred from the document about "acceptance criteria" and "study":

While not explicitly called "acceptance criteria" in the AI/ML sense, the core of this 510(k) is demonstrating performance equivalent to the predicate device. The "study" here is essentially the comparison itself, showing that the new device measures intraocular pressure effectively and safely, similar to its predecessor.

1. A table of acceptance criteria and the reported device performance:

• Inferred "Acceptance Criteria": The primary "acceptance criteria" for a 510(k) device like this is demonstrating substantial equivalence to the predicate device (Canon TX-10 Tonometer) in terms of safety and effectiveness. This is achieved by showing that the new device performs its intended function (measurement of intraocular pressure) within similar parameters and doesn't raise new questions of safety or effectiveness.
• Reported Device Performance: The primary "performance" reported is through the "CANON TONOMETER COMPARISON CAHRT" included in the document. This chart compares technical specifications, implying that similar specifications and functionality demonstrate equivalent performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. For a 510(k) of this nature, clinical study data with specific patient sample sizes, if any, would be presented in a separate section if required for demonstrating equivalence beyond technical specifications, or would be part of internal testing not explicitly detailed in the public 510(k) summary. The comparison chart indicates technical equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. This is a physical measurement device, not an interpretive AI system. "Ground truth" would refer to the true intraocular pressure, typically measured by a gold standard method. Clinical studies, if performed, would compare the device's measurements against such a standard, but details are not in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided.

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:

• Not applicable. This device is not an AI-assisted diagnostic tool involving human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a standalone tonometer, a physical device, not an algorithm. Its performance is its ability to measure IOP. The comparison chart serves as the "standalone" performance assessment by comparing its specifications to a predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not explicitly stated in the summary. For a tonometer, the "ground truth" would implicitly be the actual intraocular pressure, potentially verified by a reference tonometer or a more invasive gold standard (e.g., manometry in a research setting) if clinical accuracy studies were conducted. However, the FDA found substantial equivalence based on the technical comparison.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI/ML device that undergoes "training."

9. How the ground truth for the training set was established:

• Not applicable/Not provided.

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