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The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used for the measurement of intraocular pressure of the human eye.

The Reichert Tono-Vera® Tonometer is a hand-held, battery powered instrument that utilizes rebound methodology to measure the intraocular pressure (IOP) of the eye. The tonometer propels a small, plastic-tipped measurement probe in a controlled manner against a patient's unanesthetized eye in order to calculate IOP. The device has a simple, four-button control system and an LCD that provides information to the operator and displays measurement results.

There are two Tono-Vera Tonometer models:
· Tono-Vera Tonometer Starter Kit, AA Battery, Model 16305; and
• Tono-Vera Tonometer Starter Kit, Rechargeable, Model 16306.

Both models of the Tono-Vera Tonometer have a required accessory, the Ocu-Dot® Tonometer Probe, model 16318. The Ocu-Dot Tonometer Probe is a sterile, single-use, disposable accessory.

The Tono-Vera Tonometer utilizes a camera-based alignment system, called ActiView™ to improve alignment with the apex of the cornea and reduce measurement variability caused by operator technique. The measuring process starts automatically once alignment conditions are fulfilled.

The device has two measurement options: 3+ (Quick) Measurement Option and 6 Measurement Option. Both the 3+ (Quick) Measurement Option and 6 Measurement Option use the same calculation for the IOP result. The 3+ (Quick) Option can calculate a final IOP result with as few as three measurements. The 6 Measurement Option always uses six measurements to calculate the final IOP result.

The Tono-Vera Tonometer can be connected to a computer with ReichertSync® installed on it. Data from ReichertSync can be imported by an EMR system.

The Tono-Vera Tonometer determines IOP by detecting and analyzing the motion of the measurement probe as it briefly contacts the cornea.

Here's an analysis of the acceptance criteria and the study proving the device meets it, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text primarily focuses on demonstrating substantial equivalence to a predicate device (Icare Ic100) and meeting an industry standard (ANSI Z80.10-2014) for tonometry. Specific numerical acceptance criteria for a direct comparison study between the Tono-Vera Tonometer and the Goldmann Applanation Tonometer are not explicitly stated as a table within the document. However, the performance metrics reported against the predicate device give us an indication of the performance expected and validated.

Study Details Proving Acceptance Criteria

The text describes two main evaluations:

• Bench Test Comparison against Predicate Device (Icare Ic100): This study focused on demonstrating similar or improved performance characteristics compared to a legally marketed device.
• Clinical Study against Goldmann Applanation Tonometer (referencing ANSI Z80.10-2014 standard): This study aimed to demonstrate the device's fundamental safety and effectiveness for IOP measurements.

Here's the breakdown of details for the latter, more comprehensive study:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The text only mentions "Reichert conducted a clinical study."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The study compared the device against the Goldmann Applanation Tonometer, which is the "gold standard" for IOP measurement. The implication is that the measurements from this standard device served as the reference for ground truth.

4. Adjudication Method for the Test Set

• The text does not mention any adjudication method. The comparison was against the Goldmann Applanation Tonometer, implying that its measurements were considered definitive.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The clinical study was focused on the Reichert Tono-Vera Tonometer's equivalence to the Goldmann Applanation Tonometer based on the ANSI Z80.10-2014 standard. There is no mention of comparing human readers with AI assistance versus without AI assistance. The Tono-Vera Tonometer itself uses a camera-based alignment system (ActiView™) which aids the operator, but this isn't presented as a human-AI comparison study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone (algorithm only) performance study was not explicitly described. The device is a tonometer operated by "properly trained eye care professionals," implying human interaction is integral to its use. While the "ActiView™" system has an auto-measure mode, the context suggests it's still part of a human-operated workflow, not a standalone AI device.

7. The Type of Ground Truth Used

• External Reference Standard: The ground truth for the clinical study was established by comparison to the Goldmann Applanation Tonometer (GAT), which is widely considered the gold standard for intraocular pressure (IOP) measurement. The study aimed to demonstrate equivalence "per the requirements of the ANSI Z80.10-2014 standard," which likely sets performance benchmarks relative to GAT.

8. The Sample Size for the Training Set

• Not applicable/Not mentioned. The text describes performance testing and a clinical study, but does not refer to a "training set" in the context of machine learning. The device utilizes an "ActiView™" camera-based alignment system, which might involve internal algorithms, but no specific machine learning training data or training set size is provided.

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

• Not applicable/Not mentioned. As no machine learning training set is explicitly discussed, there's no information on how its ground truth might have been established.

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