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Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.

Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity.

Giftlife Blastocyst Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from day 3 to the blastocyst stage. This medium is not intended for transferring embryos to the uterine cavity.

Giftlife Single Step Medium is used for culture of embryos from fertilization to the blastocyst stage.

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This FDA clearance letter for the Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

The provided document is a standard 510(k) clearance letter, which confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, outlining the general controls provisions, potential additional controls, and responsibilities of the manufacturer.

Specifically, the letter does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample size, data provenance, or details of a test set.
• The number or qualifications of experts, or any adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Details of a standalone (algorithm-only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set or how its ground truth was established.

These types of details would typically be found in the 510(k) summary or the full 510(k) submission, neither of which is contained within the provided document. The clearance letter acknowledges the submission, but does not reiterate its technical content in this level of detail.

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