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The Staurenghi Wide Field Scanning laser lens is indicated for use whenever a wide field scanning laser ophthalmoscope is indicated.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Staurenghi Wide Field Scanning Laser Lens." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets those criteria based solely on the input provided. The input solely focuses on regulatory approval, not on the technical performance study details.

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Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.

Disposable Vitrectomy Lens

This document is a 510(k) clearance letter from the FDA for a Disposable Vitrectomy Lens. It does not contain information about acceptance criteria or a study proving the device meets them. The letter simply states that the FDA has reviewed the 510(k) notification and found the device to be substantially equivalent to devices marketed prior to May 28, 1976.

Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a study report.

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