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ORIGIO® Handling™ is intended for in vitro procedures involving handling and micromanipulation of gametes and embryos outside the CO2 incubator.

Indication includes oocyte retrieval including follicle flushing, gamete (oocyte/sperm) and embryo washing, and micromanipulation procedures including Intra Cytoplasmic Sperm Injection (ICSI), assisted hatching and trophectoderm biopsy.

ORIGIO® Handling™ is a non-viscous, ready-to-use solution providing supporting conditions for human gametes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside the CO2 incubator. This product can also be used for oocyte retrieval including follicle flushing.

ORIGIO® Handling™ consists of amino acids, glucose, physiological salts, calcium lactate, sodium pyruvate, vitamins, sodium bicarbonate MOPS/HEPES, human serum albumin, and gentamicin sulfate. This product is supplied with phenol red (Cat. No. 8311) or without phenol red (Cat. No. 8310).

ORIGIO® Handling™ is a single-use device that is aseptically filled into sterilized bottles (60 and 125 ml) and has a sterility assurance level (SAL) of 103. The product is stored at 2-8℃, and if not warmed, the product can be used for up to seven days after bottle opening. Prior to use, ORIGIO® Handling™ must be pre-warmed to 37℃, except for sperm washing procedures where the product is pre-warmed to room temperature before use.

The provided document describes the ORIGIO® Handling™ reproductive media, but it does not contain information about an AI/ML device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI/ML device meets them based on the provided text. The document describes a traditional medical device (reproductive media) and its non-clinical performance testing.

Here's why I cannot provide the requested information:

• No AI/ML Component: The text describes the reproductive media's composition, use, and validation through standard laboratory tests (pH, osmolality, mouse embryo assay, human sperm survival assay, biocompatibility, sterility, endotoxin). There is no mention of an algorithm, artificial intelligence, machine learning, or any computational component that would require acceptance criteria related to its performance on data.
• No "Device Performance" Table for AI: The "reported device performance" in the document refers to validation test results for the media itself (e.g., pH range, osmolality range, MEA blastocyst development rate). It does not report metrics like accuracy, sensitivity, specificity, AUC, or other common performance indicators for AI/ML models.

If you have a document describing an AI/ML medical device, please provide that, and I would be happy to help with your request.

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