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HSA-solution contains Human Serum Albumin solution (100 mg/mL) and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of HSA-solution as a supplement for culture medium. Not for use as an injectable product.

Human Serum Albumin solution. For supplementation of gamete and embryo media.

The provided text is a 510(k) premarket notification summary for a medical device called HSA-solution™. It primarily discusses the regulatory aspects of the device, its intended use, and its substantial equivalence to a predicate device.

It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval notice, not a performance study report.

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