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The MENTOR TONO-PEN 3 is used to measure the intraocular pressure (IOP) during routine eye examination or when an increased IOP is suspected.

The MENTOR TONO-PEN 3 is a precision electronic tonometer which measures intraocular pressure [IOP]. The body of the instrument is specially designed to fit comfortably in the user's hand, facilitating fast and accurate measurements.

TONO-PEN 3 contains an elemental silicon strain gage which converts intraocular pressure to an electrical signal. The pen displays each valid reading on a liquid crystal display [LCD]. When four valid readings are obtained, a mean IOP reading and an indication of reliability are shown on the LCD. The TONO-PEN 3 has a molded plastic tip which must be covered by a latex protective membrane. MENTOR Ocu-Film Tip covers are recommended.

This submission explicitly states, "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical." Therefore, there is no information in the provided text to describe acceptance criteria or a study that proves the device meets them.

The sections requested in the prompt, such as acceptance criteria, reported device performance, sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for the training set, cannot be answered from the provided document.

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