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V-DENUPET is used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of oocytes and embryos during assisted reproductive techniques (ART). V-DENUPET is not intended for biopsy of cells from oocytes or embryos.

The V-DENUPET is a polycarbonate micropipette. All tips are 90 mm in length, and depending on the size of the tip have a volumetric capacity of 20-25 µl. All pipettes have an outer diameter of 900 µm at the proximal end that is connected to an aspiration device.

The V-DENUPET is supplied in a range of inner diameter sizes at the distal end as shown below:

• Sizes 125 µm, 135 µm, 140 µm, 150 µm, and 175 µm are suitable for oocyte . denudation.
• Sizes 175 µm, 200 µm, 275 µm, 300 µm, and 600 µm are suitable for oocyte . and embryo handling.
  V-DENUPET micropipettes are radiation sterilized and provided in a sterile pouch containing a polypropylene vial containing 10 micropipettes. Each pipette is for single-use only.

The provided text describes the V-DENUPET, a micropipette used in Assisted Reproductive Technologies (ART). However, it does not include acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/algorithm performance. The document is an FDA 510(k) summary for a medical device (a micropipette), focusing on non-clinical performance testing for physical characteristics, sterility, and biocompatibility, not for an AI device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, study details, sample sizes, expert qualifications, or MRMC studies, as this information is not present in the provided text.

The closest relevant information from the document is related to the device's performance criteria, not an AI algorithm:

Acceptance Criteria and Reported Device Performance (Non-AI device)

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