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Ultra-Fast Vitri is indicated for use in the preparation, vitrification and storage of oocytes (MII).
Ultra-Fast Warm is indicated for use in the preparation and warming of vitrified oocytes(MII).

The Ultra-Fast Vitri and Ultra-Fast Warm is composed of a set of three media to vitrify and warm oocytes for assisted reproductive technology (ART) procedures.

The Ultra-Fast Vitri includes two components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol and dimethyl sulfoxide. There are two vitrification procedures to choose from. During the vitrification process, oocytes are first exposed to ES then in VS within several minutes. Using this methodology, permeating cryoprotectants can replace water in the oocytes prior to vitrification and storage in liquid nitrogen. The Ultra-Fast Vitri comes prepackaged with 1.5 mL vial or 4 mL vial of ES, three 1.5 mL vials or three 4 mL vials of VS.

Ultra-Fast Warm is composed of one media used for warming and removing cryoprotectants from vitrified oocytes. It is composed of Thawing Solution (TS). The Ultra-Fast Warm comes pre-packaged with four 4.0 ml vials of TS.

All the media in the Ultra-Fast Vitri and Ultra-Fast Warm contain Gentamicin. The media undergoes aseptic filtration, while the vials are sterilized by radiation.

Based on the provided FDA 510(k) Clearance Letter, here's a description of the acceptance criteria and the study that proves the device meets them:

Device: Ultra-Fast Vitri; Ultra-Fast Warm
Description: A set of three media used for the vitrification (cryopreservation) and warming of oocytes (MII) for Assisted Reproductive Technology (ART) procedures.

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device, as demonstrated through non-clinical and clinical performance data, revolve around its biological compatibility and effectiveness in preserving and recovering oocytes without compromising their viability or subsequent reproductive outcomes.

Study Proving Device Meets Acceptance Criteria

The provided document describes both non-clinical (bench) and clinical performance studies to demonstrate the safety and effectiveness of the Ultra-Fast Vitri and Ultra-Fast Warm device and its substantial equivalence to the predicate device.

1. Non-Clinical Performance Data (Bench Testing):

• Description: A series of laboratory tests conducted directly on the media to confirm its physical, chemical, and biological properties.
• Specific Tests: Color/Appearance, pH Testing, Endotoxin testing, Osmolality Testing, Sterility Testing, Gentamicin Test, Initial Media Dispensing Validation, Mouse Embryo Assay (MEA), and Biocompatibility.
• Proof of Concept: The device passed all these tests, including achieving >80% one-cell development in the Mouse Embryo Assay, which is a critical biological performance indicator for reproductive media as per FDA guidance.

2. Clinical Performance Data:

• Study Design: A comparative study referenced from literature that evaluated the effectiveness of the ultra-fast vitrification and warming protocols using the subject device against conventional protocols (presumably using the predicate or similar conventional vitrification/warming solutions).
• Study Objective: To demonstrate comparable outcomes (oocyte survival, clinical pregnancy, live birth rates) between the ultra-fast protocol and conventional protocols.

Here's a breakdown of the specific requested information about the clinical study:

• 2. Sample Size Used for the Test Set and Data Provenance:

  • Sample Size: 1,077 mature oocytes in total.
    • 519 oocytes for the conventional vitrification and warming protocols group.
    • 558 oocytes for the ultra-fast protocols (subject device) group.
  • Data Provenance: The document states "The referenced literature used Kitazato's vitrification and warming solutions (K171748 and K160864)".
    • It does not explicitly state the country of origin of the data.
    • It does not explicitly state if the study was retrospective or prospective. However, given it's a "study" comparing protocols, it's typically prospective, but this cannot be confirmed from the text.

• 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

  • This information is not provided in the document. The study focuses on clinical outcomes (survival, pregnancy, live birth rates) rather than human interpretation of images or other subjective assessments that would require expert consensus for ground truth.

• 4. Adjudication Method for the Test Set:

  • This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation where reviewer disagreement needs to be resolved (e.g., radiology studies). This study measures biological/clinical outcomes.

• 5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

  • No, an MRMC study was not done. MRMC studies are used to assess the impact of a device (often AI) on human reader performance, typically in diagnostic imaging. This study evaluated the direct clinical effectiveness of the media itself.
  • Therefore, an effect size of how much 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) Study was Done:

  • Yes, in a sense, the clinical study assessed the "standalone" performance of the media with its associated protocols. It compared the outcomes from using the media (with its specific ultra-fast protocol) to conventional media/protocols. There isn't an "algorithm" in the traditional sense for this device; it's a chemical formulation and protocol. The "performance" is the biological outcome achieved by the oocytes.

• 7. The Type of Ground Truth Used:

  • The ground truth was based on clinical outcomes data:
    • Oocyte survival rate after vitrification and thawing.
    • Clinical pregnancy rate (following embryo transfer resulting from these oocytes).
    • Live birth rate (following clinical pregnancy).
  • These are considered objective biological and clinical endpoints.

• 8. The Sample Size for the Training Set:

  • This information is not applicable/not provided. This device is a media (consumable), not an AI algorithm that requires a separate "training set" of data. The "development" of the media and protocols would be based on laboratory research and refinement rather than a data training paradigm.

• 9. How the Ground Truth for the Training Set Was Established:

  • This information is not applicable/not provided for the same reasons as #8.

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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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