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Dewin Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Dewin Thawing Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Dewin Vitrification Kit and Dewin Thawing Kit include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.

The Vitrification Kit and Thawing Kit media are offered in 2mL and 5mL volumes. Dewin Vitrification Kit includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS. Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.

Dewin Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Dilution Solution (DS) and Washing Solution (WS).

The primary ingredients of the vitrification and thawing media are water, sodium chloride, potassium chloride, sodium dihydrogen phosphate dihydrate, magnesium sulphate heptahydrate, calcium chloride, sodium bicarbonate, gentamicin sulfate, glucose, sodium-s-lactate, sodium pyruvate, alanyl glutamine, taurine, EDTA, phenol red, HEPES, HSA, trehalose, ethylene glycol, DMSO, non-essential amino acids. Cryoprotectants in the media include ethylene glycol (7.5% in ES, 15% in VS), DMSO (7.5% in ES, 15% in VS), and trehalose in VS, TS and DS.

The five solutions in the Dewin Vitrification Kit and Dewin Thawing Kit are aseptically filtered (storage vials sterilized by dry heat and radiation) and provided in glass bottles capped with a polypropylene screw-top cap. They are single-use only and have a shelf-life of 7 months when stored at 2-8°C.

The provided FDA clearance letter and 510(k) summary pertain to the Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit). This document does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness with AI. Therefore, most of the requested information (such as effect size of human readers with AI assistance, expert qualifications, and adjudication methods) is not applicable or cannot be extracted from the given text.

The information below focuses solely on the device and its testing as described in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dewin Reproductive Media are primarily based on physical, chemical, and biological performance measures. The reported device performance matches these criteria for the supported shelf-life.

2. Sample size used for the test set and the data provenance

The document does not explicitly state specific sample sizes for each test mentioned (e.g., how many batches were tested for pH, osmolality, sterility, or bacterial endotoxin).

For the Mouse Embryo Assay (MEA), the criteria indicate the measurement is "≥ 80% embryos developed to expanded blastocyst at 96 hours." While not explicitly stated as a "test set" in the context of AI, this biological performance test would involve a certain number of mouse embryos. The document does not specify this number.

Data Provenance: The studies were conducted by DonneVie Medical Technology (Shanghai) Co. Ltd. (China) to support the substantial equivalence claim. The document does not specify the country of origin for the biological samples (e.g., mouse embryos) used in the MEA. The studies are assumed to be "prospective" in the sense that they were designed and performed to generate data for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is reproductive media, not an AI/ML diagnostic or image analysis device that requires expert ground truth establishment in the traditional sense. The performance criteria are objective laboratory measurements (pH, osmolality, sterility, endotoxin) and a biological assay (MEA).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as expert adjudication is not relevant for the type of objective laboratory tests performed for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is reproductive media, not an AI/ML diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance evaluation of this reproductive media is based on:

• Objective Laboratory Measurements: pH, Osmolality, Sterility, Bacterial Endotoxin, Appearance. These have established scientific and regulatory standards (e.g., USP monographs).
• Biological Functionality Assay: Mouse Embryo Assay (MEA), which assesses the ability of the media to support embryonic development in vitro to a certain stage (expanded blastocyst). This assay serves as a functional "ground truth" for the media's biological suitability.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

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