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The Vitrification Kit is indicated for use in the preparation, vitrification and storage of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.

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

The Vitrification and Thawing Kits are composed of a set of six media to vitrify and warm MII oocytes, and pronuclear (PN) zygotes through blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.

The Vitrification Kit includes three media components, Basic Solution (BS), Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose, and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS. In the case of the oocytes, use BS and ES. Using this methodology, the permeating cryoprotectants can replace water in the occyte, PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen. The Vitrification Kit comes prepackaged with one 1.5 ml vial of BS and ES, two 1.5 ml vials of VS, 4 Cryotop devices (Cryotop CL, Cryotop SC, or Cryotop US), and 2 Repro Plates.

The Thawing Kit is composed of three media used stepwise for thawing cryoprotectants from vitrified oocytes, and PN through blastocyst stage embryos. The Thawing Kit is composed of TS (Thawing Solution), DS (Dilution Solution) and WS (Wash Solution). The Thawing Kit comes pre-packaged with two 4.0 ml vials of thawing solution, one 4.0 ml vial of dilution solution, one 4.0 ml vial of washing solution, one Repro Plate, and two 35 mm dishes.

All the media in the Vitrification Kit contain Gentamicin. The media in these kits undergo aseptic filtration, while storage devices and plates are sterilized by radiation.

The provided document describes the Vitrification Kit and Thawing Kit (K171748) and its substantial equivalence to a predicate device. Below is an attempt to extract the requested information, though it's important to note that this document is a 510(k) Summary, which focuses on demonstrating substantial equivalence rather than a full study report with detailed acceptance criteria and performance data in the format often associated with AI/software performance studies. The device is a "Reproductive Media and Supplements," which are chemical reagents, not an AI/software device, so many of the requested fields (like AI-specific performance metrics, reader studies, etc.) are not directly applicable.

Here's the information based on the provided text:

Acceptance Criteria and Device Performance

Since this is a submission for a "Reproductive Media and Supplements" kit, the acceptance criteria are related to the biological outcome (survival, development, etc.) of oocytes and embryos rather than typical device performance metrics like accuracy, sensitivity, or specificity of an AI algorithm. The performance is compared to similar existing products (predicate device or other vitrification media).

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not explicitly stated as a single "test set" number. The evidence comes from three published scientific papers.
     • Literature 1 (Coello et al, 2016): Retrospective cohort study.
     • Literature 2 (Mori et al, 2015): Not specified in the summary, but likely a study comparing different methods.
     • Literature 3 (Inoue et al, 2014): Not specified.
   • Data Provenance: Not explicitly stated for all, but Coello et al. is published in Journal of Assisted Reproduction Genetics, typically international. Mori et al. published in Reproductive BioMedicine Online. Inoue et al. in Low Temp Med. Specific countries of origin for the patient data are not detailed in this summary. The studies appear to be retrospective and prospective clinical/bench studies, but specific details for each are not fully provided in this summary.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable in the context of this device (Reproductive Media Kit). The "ground truth" for the performance claims would be the observed biological outcomes (survival, fertilization, development to blastocyst, pregnancy, live birth rates) reported in the referenced scientific literature, likely assessed by trained embryologists and clinicians.

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

   • Not applicable. This is not an AI/image analysis device requiring expert adjudication of outputs.

4. 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 is not an AI device. The comparison is between different media formulations and vitrification methods.

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

   • Not applicable. This is not an AI/algorithm device.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • The "ground truth" here is outcomes data and biological observations from clinical and laboratory studies reported in published literature, such as oocyte/embryo survival rates, fertilization rates, blastocyst development, implantation rates, clinical pregnancy rates, and live birth rates.

7. The sample size for the training set

   • Not applicable. This is a medical device (chemical media), not an algorithm or AI model that requires a training set.

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

   • Not applicable. (See #7).

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Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Sage IVF's Vitrification Warming Kit (Ref # ART-8030) for optimal recovery of specimens.

Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Sage IVF's Vitrification Kit (Ref # ART-8025) for Assisted Reproductive Technology (A.R.T.) procedures.

There are five (5) solutions that comprise the two kits, Vitrification Kit and Vitrification Warming Kit.

Vitrification Kit: Consists of two solutions, Equilibration Solution (ES) and Vitrification Solution (VS) that are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts.

Equilibration Solution is used in preparation for freezing and contains dimethyl sulfoxide (DMSO) and ethylene glycol (EG).

Vitrification Solution is to be used during cryostorage and contains DMSO and EG and sucrose.

Vitrification Warming Kit: The three (3) warming solutions, 1.0 M Sucrose Warming Solution, 0.5 M Sucrose Warming Solution and MOPS Solution, are also intended for sequential use in the warming and recovery of cryopreserved human blastocysts.

This document is a 510(k) summary for the SAGE In-Vitro Fertilization Vitrification Kit and Vitrification Warming Kit. It does not contain acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Specifically, the document states:

• "The technological characteristics of the Sage products as compared to the predicate products are similar in the following areas and do not compromise the safety or efficacy of the device:
  • Indications For Use
  • Formulae
  • Performance testing
  • Sterility"

This indicates that SAGE is relying on the established performance and safety of its predicate devices and making a claim of substantial equivalence based on similar characteristics and the absence of new safety or efficacy concerns. A detailed study with acceptance criteria and device performance metrics would typically be submitted to demonstrate conformity to a specific standard or a novel device's performance, which is not the primary purpose of this 510(k) summary for these "reproductive media" devices.

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