Search Results

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).

Ask a specific question about this device