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The Gems Vitrification Set is designed to facilitate dehydration of blastocysts before vitrification via rapid cooling in liquid nitrogen. Dehydration of the blastocysts is achieved by the step-wise use of increasing concentrations of cryoprotectants in the Gems Vitrification Set, which results in water being withdrawn from the cell. The cryoprotectants also protect the blastocysts by reducing the potential for ice crystal formation during the vitrification process.

The Gems Vitrification Set consists of three solutions (Vitsol 2, and Vitsol 3). The base formulation for Vitsol 1 and Vitsol 2 is a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin. Vitsol 1 contains the cryoprotectant ethylene qlycol, while Vitsol 2 contains the cryoprotectants ethylene glycol and trehalose. Vitsol 3 consists of dimethyl sulphoxide (DMSO). The Gems Vitrification Set is not provided ready for use as Vitsol 3 must be added to the other vitrification solutions before use. Following DMSO addition to Vitsol 1 and 2, the final vitrification solutions for blastocyst vitrification procedures have the following properties:

. Vitrification Solution 1 (Vitsol 1 + DMSO) - 8% ethylene glycol and 8% DMSO
Vitrification Solution 2 (Vitsol 2 + DMSO) 16% ethylene glycol, 16% DMSO, and 0.57M trehalose ●

The Gems Warming Set consists of three warming solutions (Warmsol 2, and Warmsol 3), which are designed to facilitate the re-hydration (warming) of vitrified blastocysts. In the warming process, trehalose in the media manages the inflow of water into blastocysts as concentrations of DMSO and ethylene glycol are reduced during the rehydration process.

All three of the solutions in the Gems Warming Set consist of a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin, with varying amounts of the cryoprotectant trehalose as described below:

. Warmsol 1 - 1.0 M trehalose
Warmsol 2 0.5 M trehalose ●
Warmsol 3 - No trehalose

These media are single-use devices that are aseptically filled into sterilized bottles and have a sterility assurance level (SAL) of 10 3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.

AI/ML Overview

The provided document describes the acceptance criteria and performance testing for the "Gems Vitrification Set and Gems Warming Set" (subject device) in comparison to a predicate device, the "Cook Sydney IVF Blastocyst Vitrification Kit and Cook Sydney IVF Blastocyst Warming Kit" (K143724).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Parameter	Subject Device - Gems Vitrification Set and Gems Warming Set (K162409) Reported Performance	Predicate Device - COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit (K143724)	Comparison
Intended Use	Vitrification and warming of human blastocyst stage embryos for ART procedures.	Vitrification and warming of human blastocysts for ART procedures.	Same
Formulation	HEPES buffered physiologic media containing ethylene glycol, DMSO, trehalose, and human serum albumin in addition to normal physiological salts. DMSO provided separately.	HEPES buffered physiologic media containing ethylene glycol, DMSO, trehalose, human Serum albumin and gentamicin in addition to normal physiological salts. DMSO provided separately.	Similar (differences in gentamicin and some concentrations, deemed not to raise different S&E questions)
pH	7.3-7.5	7.3-7.5	Same
Osmolarity (mOsm/kg)	Warmsol 1: 1280-1320; Warmsol 2: 780-820; Warmsol 3: 295-305 (N/A for vitrification solutions)	K-SIBW-SOL1: 657-683; K-SIBW-SOL2: 500-520; K-SIBW-SOL3: 285-295 (Other values for vitrification solutions not directly comparable)	Different (higher in subject device for warming solutions due to cryoprotectant concentrations, deemed not to raise different S&E questions)
Mouse Embryo Assay (MEA)	1-Cell MEA: ≥80% developed to blastocysts at 96h	2-Cell MEA: ≥80% blastocyst formation at 72h	Similar
Endotoxin	Vitsol 1-2, Warmsol 1-3: < 0.40 EU/mL; DMSO: <0.05 EU/ml	< 0.40 EU/mL	Similar
Sterilization Method	Aseptic Filtration, SAL 10⁻³	Aseptic Filtration	Same
Shelf-Life	20 weeks	20 weeks	Same

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

The document does not specify exact sample sizes for all non-clinical tests. However, for the Mouse Embryo Assay (MEA), it states: "One-cell mouse embryos were exposed sequentially to subject devices in the Vitrification and Warming Sets followed by culture at 37°C in an atmosphere containing 5% CO₂. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group."

The provenance of this data is a non-clinical study, likely conducted internally by Genea Biomedx Pty Ltd, or by a contract research organization. There is no mention of country of origin of the data or if it was retrospective or prospective in the context of human embryos. Given it's a non-clinical study using mouse embryos, these distinctions are less relevant than for human clinical trials.

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

This information is not provided in the document. The studies are non-clinical (MEA, chemical analyses, sterility, endotoxin) and likely rely on laboratory measurements and protocols rather than expert consensus for ground truth on individual test items. For the MEA, the "ground truth" would be the observed development of mouse embryos to the blastocyst stage.

4. Adjudication method for the test set

This information is not provided. Given the nature of the non-clinical tests (quantitative measurements and adherence to specified limits), a formal adjudication method by experts is not typically applicable.

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

No, an MRMC comparative effectiveness study was not done. This document describes the testing of reproductive media (Gems Vitrification Set and Gems Warming Set), which are medical devices used for in-vitro fertilization procedures, not imaging or diagnostic AI software that would typically involve human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

This question is not applicable as the device is not an AI algorithm. It is a set of chemical media. The performance assessed is the biological effectiveness (embryo development) and chemical/physical characteristics of the media themselves in standalone non-clinical tests.

7. The type of ground truth used

The ground truth for the non-clinical performance testing involved:

Quantitative laboratory measurements: For pH, osmolality, endotoxin levels, and sterility. These are objective measurements against established scientific standards and limits.
Biological endpoint observation: For the Mouse Embryo Assay (MEA), the ground truth is the observed development of 1-cell mouse embryos to the expanded blastocyst stage within 96 hours. This is an objective biological outcome.
Validation against standards: Aseptic Processing Validation met requirements in ISO 13408-2:2003. Sterility testing was per USP <71> and Endotoxin testing per USP <85>.

8. The sample size for the training set

This information is not applicable. The device is not an AI algorithm that requires a training set. The descriptions relate to the manufacturing and quality control testing of physical chemical media.

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

This information is not applicable for the same reason as point 8.

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