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The G-Vitri™ Vitrification Straw is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.

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The provided document is an FDA 510(k) clearance letter for the G-Vitri™ Vitrification Straw, a medical device used in assisted reproduction. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical study report or a detailed validation study.

The letter primarily focuses on:

• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Outlining regulatory requirements and general controls for the device.
• Defining the Indications for Use for the G-Vitri™ Vitrification Straw.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report submitted as part of the 510(k) application.

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