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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.

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