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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.

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

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

The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embrvos.

The Vitrification Kit and Warming Kit are assisted reproduction technology (ART) media products for freezing and thawing oocytes (MII), pronuclear (PN) zygotes through Day 3 cleavage stage embryos, and blastocyst stage embryos.

There are two models for each Vitrification Kit and Warming Kit. The difference is the volume of the solutions in the kits. The solutions in the "A" model for each kit are in 1 ml vials, and the solutions in the "B" model are in 2 ml vials. Each model contains two sets of kit media.

The Vitrification Kit includes three sequential media components, Washing solution (WS), Equilibrium solution (ES), and Vitrification solution (VS), containing the cryoprotectants ethylene glycol, dimethyl sulfoxide, and sucrose. Using this methodology, the permeating cryoprotectants can replace water in the oocyte and PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.

The Warming Kit is composed of three media used sequentially for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. The Warming Kit is composed of Thaw solution (TS), Diluent solution (DS), and Washing solution (WS).

All media in the Vitrification Kit and Warming Kit undergo aseptic filtration and are single-use only.

The Cryo-Straw is a single-use, sterile, cryopreservation storage device for holding and maintaining vitrified oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. There are two models for the Cryo-straws: Type I and Type III, and each has 5 colors: brown, orange, blue, red, green. The Cryo-straws are composed of a rod and sheath with a combined length of 132.5 mm. The Type I model has a flat slide and the Type III model has a curved slide for sample loading. The Cryo-straws are sterilized using gamma radiation.

The provided document is a 510(k) premarket notification for a medical device: Cryo-straw, Warming Kit, and Vitrification Kit. It details the device's indications for use, comparison to a predicate device, and non-clinical performance data.

However, this document does not describe a study involving an AI/Machine Learning (ML) algorithm or human readers aided by AI. The acceptance criteria and performance data presented are for the physical cryopreservation device and its associated media, focusing on biological and physical properties relevant to in vitro fertilization (IVF) and cryopreservation, such as pH, osmolality, sterility, shelf-life, and mouse embryo assay (MEA) results.

Therefore, I cannot provide the requested information about:

1. A table of acceptance criteria and reported device performance related to AI/ML. The acceptance criteria listed are for the physical and chemical properties of the cryopreservation media and device.
2. Sample size used for the test set and data provenance: No test set involving AI/ML is described.
3. Number of experts used to establish ground truth & qualifications: Not applicable to this device submission.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on laboratory assays (e.g., MEA, sterility, endotoxin) and physical testing.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance Criteria and Performance (from document):

The document focuses on demonstrating the substantial equivalence of the "Cryo-straw," "Warming Kit," and "Vitrification Kit" to a legally marketed predicate device (Kitazato Corporation's Vitrification Kit and Thawing Kit, K171748). This is achieved through non-clinical performance data addressing the physical, chemical, and biological properties critical for their intended use in cryopreservation of oocytes and embryos.

Here's the relevant information extracted from the document regarding the device's acceptance criteria and reported performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.

VitaVitro Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.

VitaVitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

VitaVitro Vitrification and Warming Kits, and the VitaVitro Straw Set are used for vitrification, storage, and warming of blastocysts as part of human assisted reproduction technology (ART) procedures.

The VitaVitro Vitrification Kit includes three media components, Human Holding Medium (HHM), Human Vitrification Solution 1 (HV1) and Human Vitrification Solution 2 (HV2). All three media have the same base formulation, but HV1 and HV2 contain the cryoprotectants ethylene glycol and dimethyl sulfoxide in increasing concentrations. HV2 also includes sucrose as a non-permeating cryoprotectant. During the vitrification process, blastocysts are first equilibrated in HHM, and then exposed sequentially to HV1 and HV2. Using this methodology, the permeating cryoprotectants replace water in the blastocyst prior to vitrification and storage in liquid nitrogen. The VitaVitro Vitrification Kit includes single 1.0 ml vials of HHM, HV1, and HV2.

The VitaVitro Warming Kit includes three media used stepwise for warming and removing cryoprotectants from vitrified blastocysts. The VitaVitro Warming Kit includes Human Warming Solution 1 (HW1), Human Warming Solution 2 (HW2) and HHM. These media products are the same with the exception that HW1 and HW2 also include sucrose in decreasing concentrations to aid in the rehydration of the blastocysts. The VitaVitro Warming Kit includes two 1.5 ml vials of HW1, one 1.0 ml vial of HW2, and one 1.8 ml vial of HHM.

The VitaVitro Straw Set consists of two components, a straw that holds the blastocysts, and a container that is used to protect the straw. Both components are made from copolyester. The closed end of the container also includes a weight to aid in maintaining the orientation of the device in liquid nitrogen and prevent floating. During use, the container is pre-cooled by placing the closed end in liquid nitrogen with the open end extending above the level of the liquid nitrogen. Straw loading is done by placing the narrow tip of the straw in a 1 µl drop of vitrification media, which draws the media and blastocysts into the storage device. The straw component is then inserted into the pre-cooled container component to effect vitrification. The container component is then sealed to prevent contact between the samples and liquid nitrogen.

All of the products are provided sterile with a six-month shelf-life. The media in the vitrification and warming kits undergo aseptic filtration, while the storage devices are ethylene oxide sterilized.

This document describes the premarket notification (510(k)) for the VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set, comparing it to a predicate device (Cryotop® Vitrification Kit and Cryotop® Thawing Kit, K160864).

1. Table of Acceptance Criteria and Reported Device Performance

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SAGE 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.

SAGE Vitrification Warming Kit is intended for use in the thawing of virtified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

SAGE Vitrification Kit (ART-8025 and ART-8026): This kit includes two solutions (Equilibration Solution and Vitrification Solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids. gentamicin sulfate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:

Equilibration Solution (ES): 7.5% (v/v) each of DMSO and ethylene glycol. Vitrification Solution (VS): 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose

SAGE Vitrification Warming Kit (ART-8030 and ART 8031): This kit includes three solutions (1.0M Sucrose Warming Solution [1.0 M WS], 0.5M Sucrose Warming Solution [0.5 M WS], and MOPS Solution [MS]). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0M, 0.5M, or no sucrose).

Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in either 5 ml Type 1 borosilicate glass vials with a rubber closure and an aluminum seal (ART-8025 and ART-8030) or 2 ml polypropylene vials with cap (ART-8026 and ART-8031). The solutions in ART-8025 and ART-8030 are single-use only devices, whereas solution in ART-8026 and ART-8031 are to be used within 7 days after opening.

The provided text is a 510(k) summary for the SAGE Vitrification Kit and SAGE Vitrification Warming Kit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study design with acceptance criteria for a new, AI/ML-driven medical device. Therefore, a direct response to your request, which implies an AI/ML device study, is not fully supported by the provided document.

However, I can extract the closest analogous information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" from this document as understood within the context of reproductive media and supplements, not AI/ML devices.

Here's a breakdown based on the provided document, interpreting "acceptance criteria" as product specifications and "study" as performance testing and literature review to support substantial equivalence:

1. Table of Acceptance Criteria (Product Specifications) and Reported Device Performance

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

The document does not describe a traditional "test set" in the sense of a dedicated, pre-defined dataset for a single study, as would be done for an AI/ML device. Instead, it relies on a summary of non-clinical performance testing (in-house lab tests) and clinical performance data from published journal articles.

• Non-Clinical Test Samples: Not explicitly quantified in terms of sample size (e.g., number of batches, number of media samples tested for pH, osmolality, endotoxin). The Mouse Embryo Assay (MEA) states "1-cell MEA" but doesn't specify the number of mouse embryos or replicate tests.
• Clinical Performance Data: This is derived from 9 cited journal articles. The sample sizes vary per study and are reported within the summaries:
  • Literature 1: 11 subjects, surplus MII oocytes (quantity not specified).
  • Literature 2: 6 subjects, surplus MII oocytes (quantity not specified).
  • Literature 3: General results/meta-analysis context, not a specific sample size.
  • Literature 4: 2353 MII oocytes.
  • Literature 5: 54 study subjects, 413 MII oocytes.
  • Literature 6: 37 subjects, 74 embryos.
  • Literature 7: 849 pronuclear-stage (PN) zygotes vitrified, 339 PN zygotes thawed over 103 cycles.
  • Literature 8: 24 warming cycles (after OHSS risk).
  • Literature 9: Control group of 102 warming cycles.
• Data Provenance: Not explicitly stated for all studies, but generally refers to clinical studies likely conducted in fertility clinics. The original journal articles (listed in Section XI) would contain this information. Given the context of the device and product development, it is likely these studies were retrospective or prospective clinical trials focusing on IVF outcomes. There is no mention of country of origin for the clinical data within this extract.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not directly applicable to this type of device (reproductive media). The "ground truth" for non-clinical tests is established by laboratory measurements against predefined product specifications. For the clinical performance, the "ground truth" relates to actual biological outcomes (survival, fertilization, pregnancy, live birth), which are typically reported by clinicians and embryologists involved in the treatment, not "experts establishing ground truth for a test set" in the AI/ML sense. No specific number of experts or their qualifications for establishing ground truth are mentioned.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" described as one would expect for an AI/ML device's test set. Clinical outcomes are reported as observed, not adjudicated by an independent panel.

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

Not applicable. This device is a media kit, not an interpretation tool for image data. Therefore, no MRMC study was performed or described.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done

Not applicable. This is not an AI/ML algorithm. The performance is of the media used by humans in a clinical setting.

7. The Type of Ground Truth Used

• Non-Clinical Performance:
  • Physical/Chemical Properties: Measured values (pH, Osmolality, Endotoxin) compared to defined ranges.
  • Biological Functionality: Mouse Embryo Assay (MEA) results (percentage blastocysts at 96h).
  • Sterility: Absence of microbial growth.
• Clinical Performance:
  • Clinical Outcomes Data: Survival rates, fertilization rates, clinical pregnancy rates, live birth rates following the use of the media in human oocyte/embryo vitrification and warming procedures. This is observational outcomes data from fertility treatments.

8. The Sample Size for the Training Set

Not applicable directly. This is not an AI/ML device that requires a "training set." The development of the media would involve research and formulation, but not in the sense of an AI model's training data.

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

Not applicable, as there is no "training set" for an AI/ML model for this device. The development of the media relies on cryobiology principles and empirical testing to achieve the desired cryoprotective properties and support oocyte/embryo viability.

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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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SAGE Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts in assisted reproductive technology procedures. This kit is designed to be used in conjunction with the SAGE Virtification Warming Kit (ART-8031) for optimal recovery of specimens.

SAGE Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using SAGE Vitrification Kit (ART-8026) for assisted reproductive technology procedures.

SAGE Vitrification Kit: This kit includes two solutions (Equilibration Solution and Vitrification Solution). Both solutions in the kit consist of a MOPS-buffered media containing non-essential amino acids, gentamicin suffate, and human serum albumin. These solutions also contain the cryoprotectants ethylene glycol, dimethyl sulfoxide (DMSO) and sucrose as described below:

Equilibration Solution: 7.5% (v/v) each of DMSO and ethylene glycol.

Vitrification Solution: 15% (v/v) each of DMSO and ethylene glycol, and 0.6 M sucrose

SAGE Vitrification Warming Kit: This kit includes three solutions (1.0 M Sucrose Warming Solution, 0.5 M Warming Solution, and MOPS Solution). All solutions in the kit consist of a MOPS-buffered media containing non-essential and essential amino acids, gentamicin sulfate, and human serum albumin. These solutions contain the cryoprotectant sucrose at the level described in their names (i.e., 1.0 M, 0.5 M, or no sucrose).

Solutions in the SAGE Vitrification Kit and SAGE Vitrification Warming Kit are aseptically-filtered and are provided to users in 2 ml polypropylene vials. The solutions in these kits are considered single-use devices.

This document describes the SAGE Vitrification Kit and SAGE Vitrification Warming Kit, which are used in assisted reproductive technology (ART) for the ultra-rapid freezing and warming of human blastocysts.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary includes a comparison table between the subject device (K170560) and its predicate device (K073522), which also serves to outline the acceptance criteria for various parameters. The "reported device performance" is implicitly stated as meeting these criteria for the subject device.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., MEA, endotoxin, osmolality, pH, sterility, stability). It refers to "All devices tested" in the context of stability and "Samples tested" for transportation testing.

The data provenance is not specified regarding country of origin or explicit retrospective/prospective design. However, the tests (MEA, endotoxin, etc.) are standard laboratory tests for reproductive media, usually conducted under controlled laboratory conditions rather than with human patient data.

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

This information is not applicable to this type of device and study. The "ground truth" here relates to the chemical, physical, and biological properties of the media, which are measured against established scientific and regulatory standards (e.g., USP for sterility, MEA for toxicity). Expert consensus in the clinical sense (e.g., radiologists interpreting images) is not relevant for proving the performance of vitrification media.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used for studies involving human interpretation (e.g., medical image reading) where there might be disagreement among experts. This is not applicable to the type of performance testing described for this device, which relies on objective, quantifiable laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This type of study assesses how human readers' diagnostic performance changes with or without AI assistance, which is for devices involving diagnostic or interpretive tasks. The SAGE Vitrification Kit and Warming Kit are chemical media, not a diagnostic AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. A standalone algorithm performance study is not applicable as this is not an algorithm-based device. The "performance" refers to the chemical and biological integrity of the media.

7. The Type of Ground Truth Used

The ground truth used for performance assessment consists of:

• Established scientific and regulatory specifications: These are the predefined ranges and limits for parameters like pH, osmolality, endotoxin levels, sterility assurance level (SAL), and acceptable MEA blastocyst development rates (e.g., ≥80% at 96h).
• Predicate device characteristics: The predicate device K073522's established specifications also served as a benchmark for comparison and "ground truth" equivalence.

8. The Sample Size for the Training Set

This concept is not applicable. This device is not an AI/ML algorithm that requires training data. The "training set" for physical devices could loosely refer to the initial development and optimization batches, but the document does not provide details on this. The studies mentioned are primarily for validation and verification.

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

As per point 8, this is not applicable for a chemical media product.

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The Cryotop® Vitrification Kit is indicated for use in the preparation, and storage of promuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

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

The Cryotop® Vitrification and Thawing Kits are composed of a set of five media to vitrify and warm pronuclear (PN) through blastocyst stage embryos for Assisted Reproductive Technologies (ART) procedures.

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

The Cryotop® Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified PN through blastocyst stage embryos. The Cryotop® Thawing Kit is composed of TS (Thawing Solution), DS (Dilution Solution) and WS (Wash Solution). The Cryotop 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 of the media in the Cryotop® Vitrification Kit and Cryotop® Thawing Kit contain Gentamicin. The media in these kits undergo aseptic filtration, while storage devices are sterilized by radiation.

This document describes the Kitazato BioPharma Co., Ltd. Cryotop® Vitrification Kit and Cryotop® Thawing Kit, which are reproductive media and supplements used for the cryopreservation and thawing of pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000).

Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.

COOK Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification and warming of human blastocysts as part of human ART procedures. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to re-warm them for use at a future point in time.

The COOK Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) consists of a series of 2-[4-(2-hydroxyethyl)piperazin1-yl] ethanesulfonic acid (HEPES)-buffered, physiological solutions containing increasing concentrations of functional cryoprotectants to which the embryo is sequentially exposed during cryopreservation. The first three solutions in the kit are all based upon the same formulation (known as "Cryobase buffer"), which is a 10 mM HEPES buffered media containing 20 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. The fourth solution in the kit is dimethyl sulfoxide (DMSO) and does not contain HSA or Gentamicin. The DMSO is provided for the practitioner to add to Solution 2 and Solution 3 of the vitrification kit, as described in the Instructions for Use.

COOK Sydney IVF Blastocyst Warming Kit (K-SIBW-5000) consists of three solutions which are used sequentially throughout the warming process. The three media in the kit are all based upon the same formulation of Cryobase buffer, a 10 mM HEPES buffered media containing 20 mg/mL HSA and 0.01 mg/mL Gentamicin.

The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are single use, sterile (aseptic filtration) devices.

These solutions contact the blastocyst during the vitrification and re-warming process. The solutions are removed by washing prior to embryo transfer back to the patient and are therefore non-patient contacting.

The provided document describes the COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit, and its comparison to a predicate device (K082363). The primary purpose of the submission is to justify an extended shelf-life from 8 weeks to 20 weeks for the updated device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance specifications that are considered acceptance criteria for the device. The reported performance of the proposed device is stated to be the same as the predicate device for these parameters.

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8-global® Blastocyst Fast Freeze Kit - Based on S3:

• Media Intended for cryopreservation of human blastocysts. .
  12-global® Blastocyst Fast Freeze Thawing Kit - Based on S3
• Media intended for the thawing and recovery of human blastocysts that . have been cryopreserved using the &-global® Blastocyst Fast Freeze Kit - Based on $3.

Not Found

The provided document is a 510(k) summary for the global® Blastocyst Fast Freeze Kit and global® Blastocyst Fast Freeze Thawing Kit. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies as would be found in a clinical trial report or an academic publication on a diagnostic AI device.

Therefore, most of the information requested in your prompt is not present in this 510(k) submission.

Here's what can be inferred or stated based on the provided text, and where information is explicitly missing:

1. A table of acceptance criteria and the reported device performance:

   • Not present. The document does not provide a table of acceptance criteria or performance metrics. The 510(k) process is about demonstrating substantial equivalence, not necessarily meeting pre-defined performance acceptance criteria with detailed statistical analysis.

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

   • Not present. There is no mention of a "test set" or any specific study data that would detail sample sizes, data provenance, or study design (retrospective/prospective).

3. 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 present. As there's no mention of a test set or a study involving establishing ground truth, this information is not available.

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

   • Not present. No information on an adjudication method is available.

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 present. The device described is a cryopreservation and thawing media kit for blastocysts, not an AI-powered diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this product.

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

   • Not present. This device is not an algorithm or AI.

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

   • Not present. No specific ground truth methodology is mentioned as it's not relevant to this type of device submission. Performance claim, if any, would typically be related to viability post-thaw or pregnancy rates, which would be direct outcomes, but no such study is detailed here.

8. The sample size for the training set:

   • Not present. The device is not an AI/ML algorithm that requires a "training set."

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

   • Not present. Not applicable for this device.

In summary: The provided document is an FDA 510(k) clearance letter and an "Indications for Use" statement for a reproductive media kit. It does not contain the detailed study information, acceptance criteria, or performance data typically associated with the evaluation of AI or diagnostic devices, which your questions are geared towards. The focus of this document is regulatory clearance based on substantial equivalence to predicate devices, not on proving device performance through specific clinical studies with defined endpoints and ground truth.

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Global DMSO Blastocyst Vitrification Kit:

• Intended for the vitrification (ultra-rapid freezing) and cryostorage of . human blastocysts.
  Global DMSQ Blastocyst Vitrification Warming Kit
• . Intended for the recovery and rehydration of vitrified human blastocysts
• Intended for use with blastocysts that have been vitrified using the Global . DMSO Blastocyst Vitrification Kit.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for two devices: the "Global DMSO Blastocyst Vitrification Kit" and the "Global DMSO Blastocyst Vitrification Warming Kit." This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is primarily an approval notice, stating that the FDA has determined the devices are "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements and general information but does not delve into the specific performance data or studies that would typically be included in a 510(k) submission itself.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided input. The necessary information is not present in this document.

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