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The device and accessories are indicated as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices.

The Rodenstock brand RO 5000 and RO 4000 slitlamps are instruments used for eye examination and the fitting of contact lenses. Each device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 6.3 to 12v AC and 50-60 Hz.

This document is a 510(k) summary for medical device clearance, not a study report detailing acceptance criteria for an AI/device performance study. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment cannot be extracted from the provided text.

The provided text describes two slitlamp devices, the Rodenstock RO 5000 and RO 4000, and their substantial equivalence to predicate devices (Haag-Streit 900 BQ and Topcon SL-2ED). It addresses the intended use, technological characteristics, and indications for use, stating they are "noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses."

There is no mention of:

• Specific quantitative acceptance criteria for device performance.
• Any study used to "prove" the device meets acceptance criteria in the context of a performance study (e.g., clinical trial, AI validation).
• Sample sizes for test sets or training sets.
• Data provenance or expert involvement for ground truth.
• Adjudication methods.
• MRMC studies or standalone algorithm performance.
• Types of ground truth beyond the general statement of "examination and diagnosis of eye conditions."

The 510(k) summary focuses on establishing substantial equivalence to legally marketed predicate devices, which generally involves comparing technical characteristics, indications for use, and safety, rather than presenting a performance study with explicit acceptance criteria as one would find for a novel AI or diagnostic algorithm.

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