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The YZ3 Portable Slit Lamp is intended for use in the examination of the anterior segment of the eye.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the YZ3 Portable Slit Lamp. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) letter confirms that the device is substantially equivalent to legally marketed predicate devices for its intended use (examination of the anterior segment of the eye). It outlines regulatory compliance requirements but does not detail performance studies or testing results specifically.

Therefore, I cannot provide the requested information based on the input text.

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The 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.

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This document is a 510(k) premarket notification decision letter from the FDA to Suzhou 66 Vision Tech Co., Ltd. for their ophthalmoscopes. It confirms that the device is substantially equivalent to a legally marketed predicate device.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is an administrative approval based on substantial equivalence, meaning the device is considered as safe and effective as a previously cleared device. It does not typically require detailed performance studies and acceptance criteria to be submitted or reviewed in the same way a Premarket Approval (PMA) would.

Therefore, I cannot provide the requested information based solely on the provided text. The document primarily focuses on the regulatory approval process and not on the specifics of a performance study demonstrating acceptance criteria.

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The 66 Vision-Tech YZ Slit lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

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I'm sorry, but this document is a 510(k) clearance letter from the FDA for a slit lamp. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. It mainly focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device.

Therefore, I cannot extract the requested information based on the provided text.

Ask a specific question about this device