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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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Sequential Culture Media consists of Fertilization Medium, Cleavage Medium, and Blastocyst Medium that are intended to be used sequentially from fertilization to the blastocyst stage of development. The intended uses of the Fertilization Medium, Cleavage Medium, and Blastocyst Medium are as follows:

Fertilization medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm insertion (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.

Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage to the 8cell stage of development. Cleavage Medium is not intended for transferring embryos to the uterine cavity.

Blastocyst Medium is intended for culture from the 8-cell stage to the blastocyst stage of development. Blastocyst Medium is not intended for transferring embryos to the uterine cavity.

Sequential Culture Media are intended for use sequentially from fertilization to late embryonic stages during assisted reproduction technology procedures for insemination and embryo culture.

The Sequential Culture Media is provided in three variants: Fertilization Medium, Cleavage Medium, and Blastocyst Medium. Each variant is provided with or without protein (human serum albumin (HSA) or recombinant HSA (rHA)). All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. Each Sequential Culture Media solution is offered in three volumes (10mL, 50mL and 100mL).

The Sequential Culture Media solution is a colorless, clear fluid, provided sterile-filtered into a container pre-sterilized by gamma irradiation. The primary container of Sequential Culture Media 10mL is a sterile non-pyrogenic PETG vial, and the primary container of the Sequential Culture Media 50mL and 100mL is a square, non-pyrogenic PETG bottle. The containers are manufactured and provided sterile (with a SAL of 10° ) by ThermoFisher Scientific, Inc. After sterilefilling, the top of the vial and bottle are sealed with tamper-evident shrink-wrap.

The provided text is a 510(k) Summary for a medical device called "Sequential Culture Media." It details the device's characteristics, comparison to a predicate device, and non-clinical performance testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI/ML product (culture media for IVF), so the acceptance criteria are not in terms of AI model performance metrics like accuracy, sensitivity, or specificity. Instead, they are related to the physical and biological properties of the culture media.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in the way an AI/ML study would. Instead, performance testing applies to batches of the culture media. For the MEA, it mentions "1-cell mouse embryos," but the exact number of embryos or experimental replicates used is not provided.
• Data Provenance: The studies were non-clinical performance testing conducted by Kitazato Corporation, the device manufacturer. The data provenance is internal to the manufacturer.

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

Given this is a non-clinical, laboratory-based product, the concept of "experts establishing ground truth" as it applies to image interpretation or diagnostic accuracy is not directly applicable. The "ground truth" here is based on analytical chemistry, biological assays, and sterility testing, which are measured objectively using established scientific methods and standards (e.g., USP, ISO). The qualifications of those performing these tests would be standard laboratory technicians/scientists, but no specific details on their number or qualifications are provided.

4. Adjudication Method for the Test Set

Not applicable. This is not a human-reader-based test where adjudication would be necessary. The results are based on objective laboratory measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic device that involves human readers or AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This is not an algorithm or AI device. The device itself is the sequential culture media.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the objectively measured characteristics of the culture media that are critical for its function and safety. This includes:

• Analytical Chemistry/Physical Measurements: pH, Osmolarity, Endotoxin levels.
• Biological Assay: Mouse Embryo Assay (MEA), which assesses the biological efficacy by observing embryo development.
• Microbiology: Sterility testing.
• Material Science/Engineering: Container seal integrity, package integrity.

These are established scientific and regulatory standards.

8. Sample Size for the Training Set

Not applicable. As a non-AI/ML product, there is no "training set." The product's formulation and manufacturing processes are developed based on scientific understanding of embryo culture requirements and validated against performance specifications, not through machine learning training.

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 formulation and manufacturing parameters are likely established through R&D, chemical engineering, and biological testing, informed by existing scientific knowledge and regulatory requirements for reproductive media.

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iMedium Single Step media are intended to be used as culture media for gametes and embryos from fertilization through day 5/6 of development. iMedium Single Step media are not intended for embryo transfer procedures.

The Kitazato iMedium Single Step media are culture media used in assisted reproductive procedures. The iMedium Single Step media are designed for development of the embryo from fertilization through day 5/6 until the embryo transfer, in a continuous and uninterrupted culture system without the need to change media. The iMedium Single Step media are provided in three variants: without protein (Model: IM-S), with human serum albumin (HSA; Model: IM-SS), and with recombinant human albumin (rHA; Model: IM-SC). All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. Each iMedium Single Step solution is offered in three volumes (10mL, 50mL and 100mL). Each iMedium Single Step solution is a colorless and clear fluid. The product is single-use only, provided aseptically-filtered in a container sterilized by gamma irradiation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the iMedium Single Step device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the sample sizes used for the non-clinical tests (e.g., number of mouse embryos for MEA, number of batches for sterility, etc.).

Data provenance: The testing was conducted by Kitazato Corporation, the manufacturer, as internal non-clinical tests. The country of origin for the data is Japan, based on the manufacturer's address (Kitazato Corporation, Japan). The data is retrospective as it was collected before the 510(k) submission.

3. Number of Experts and their Qualifications

This information is not provided in the document. The non-clinical tests described are laboratory-based and do not inherently involve human expert interpretation in the way a diagnostic imaging device might.

4. Adjudication Method

This information is not applicable as the non-clinical tests described do not involve human interpretation or subjective assessment that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a culture medium, not a diagnostic imaging or interpretive aid that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The non-clinical performance data described (pH, endotoxin, MEA, sterility, etc.) represents the performance of the algorithm/device (the culture medium itself) without human intervention during the actual performance measurement. The purpose of these tests was to demonstrate the inherent safety and effectiveness characteristics of the iMedium Single Step media.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests was established through:

• Laboratory measurements/standards: For pH (USP ), Endotoxin (USP ), Sterility (USP ), and Osmolarity (freezing point depression method), the ground truth is based on established scientific and regulatory standards for these measurements.
• Biological assay outcomes: For the 1-Cell Mouse Embryo Assay (MEA), the ground truth is the biological outcome of embryo development to the expanded blastocyst stage within 96 hours. This is a recognized biological endpoint for assessing the suitability of reproductive media.
• Engineering/Quality standards: For shelf-life, transportation testing (ASTM D4169-16), and sterilization validation (ISO 13408-1:2008 / A1:2013, ISO 13408-2:2018), the ground truth refers to meeting the specified parameters and requirements outlined in these engineering and quality standards.

8. Sample Size for the Training Set

This information is not applicable/not provided. This device is a medical device (culture medium) and not an AI/ML algorithm that requires a training set in the conventional sense. The development of the medium would involve formulation scientists and biologists, rather than an AI training process.

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

This information is not applicable/not provided for the same reasons mentioned in point 8.

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Sperm Freeze is intended for the cryopreservation of human semen samples prior to use in assisted reproductive technology procedures.

Sperm Fridge is intended to protect human semen samples during refrigerated storage prior to use in assisted reproductive technology procedures.

Sperm Freeze and Sperm Fridge are preservation media intended for preserving sperm (short-term and long-term) for in vitro fertilization (IVF) and assisted reproduction technologies (ART). There are two methods for sperm preservation; freezing and refrigeration. Freezing is necessary for long-term sperm preservation, but may have disadvantages such as reduced survival rate and/or sperm motility after thawing. Refrigeration makes it possible to preserve sperm for several days without freezing and may be preferable for short-term preservation. Both products are intended to be used exclusively in a laboratory environment by trained professionals.

Sperm Freeze is a is a Tris-buffered solution containing the cryoprotectants glycerol and trehalose that is used for long-term sperm cryopreservation procedures. Sperm Fridge is a buffered solution (TES and Tris) that includes a nutrient source for sperm (dextrose) that is used for short-term sperm preservation procedures. Sperm Freeze and Sperm Fridge are offered in two volumes (0.5 mL and 10 mL, and 0.5 mL is sold in a pack of 5).

Here's a breakdown of the acceptance criteria and study information for the "Sperm Freeze, Sperm Fridge" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The "Reported Performance" column indicates that the device "passed" or "met criteria" based on the general statement in section 9: "Results confirm that the design inputs and performance specifications for the devices are met." Specific numerical results for each test (e.g., the exact percentage for sperm survival) are not provided in this summary.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Kitazato completed the following non-clinical tests" and refers to "internal requirements, national standards, and international standards."

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

This information is not provided in the document. The studies described are non-clinical (laboratory testing of the media itself), not clinical studies involving human samples and expert evaluation of outcomes in the way one might see for an AI diagnostic device.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests described are non-clinical and do not involve human interpretation or adjudication of results.

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:

This is not applicable. The device (Sperm Freeze, Sperm Fridge) is a reproductive media product, not an AI or imaging device that would involve human readers or AI assistance in interpretation. No MRMC study was conducted.

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

This is not applicable. The device is a chemical medium, not an algorithm or software. No standalone performance testing in this context was performed.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests appears to be laboratory measurements against established specifications and standards. For example, the pH measurement would be compared to the specified pH range (7.2-7.6), endotoxin levels compared to the maximum allowed (≤ 0.25 EU/mL), and sperm survival rates compared to the minimum required (≥ 80%). The "ground truth" is essentially the predefined acceptable range or threshold for each physical/chemical/biological property of the media.

8. The Sample Size for the Training Set:

This is not applicable. The device is a manufactured product, not a machine learning model that requires a training set.

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

This is not applicable for the same reasons as #8.

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Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.

Kitazato ET Catheters are sterile, single-use catheters for use in embryo transfer procedures. The catheter is used to hold and deliver embryos to the uterine cavity during a procedure. Catheters are available in 3Fr and 4Fr sizes, both of which are provided in lengths of 220 mm and 250 mm, as well as one version that is 3Fr and 400 mm length that has the same uterine insertion depth as the other device versions, but allows the user to be positioned further from the patient during a procedure. Devices also include versions with and without an echo reflective chip in the tip of the catheter. The echo reflective chip aids in visualization of the catheter during a transfer procedure; all transfer procedures are to be done under ultrasound guidance. Both the Type 2 devices also include a stainless steel or polyimide core to provide additional rigidity to the catheter. The guide is used to navigate the pathway through the cervical canal to allow for easier catheter insertion Guides are provided with a 30° pre-curved distal shaft and are available in lengths of 170 mm and 200 mm. Guides also include a styrene elastomer stopper to aid in positioning the targeted uterine insertion depth. The guides are also available with a straight or bulb tip design, and with and without an echo reflective chip in the tip of the guide. An obturator with a length of 170 mm or 200 mm is provided with the Type 2 versions of the device to prevent ingress of fluid into the guide lumen during guide insertion. The Stylet is an optional accessory used when additional rigidity is needed during insertion of the guide through the cervix, and is provided in two lengths, 170 mm and 200 mm. The stainless steel core of the Stylet can be shaped to aid in guide delivery through the cervix.

This document describes a 510(k) premarket notification for the Kitazato ET Catheters. The focus of the provided text is on demonstrating the substantial equivalence of the Kitazato ET Catheters to a legally marketed predicate device (Guardia™ Access Embryo Transfer Catheter Sets). As such, the information provided is geared towards comparing the new device to an existing one, rather than establishing the performance of a novel AI/software medical device against defined acceptance criteria in the way a traditional clinical study would for an AI-powered diagnostic.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI medical device (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size and ground truth establishment) is largely not applicable to this submission.

This submission is for a physical medical device (catheters) and relies on bench testing and biocompatibility studies to show substantial equivalence, not a clinical study involving human readers and AI performance.

However, I can extract information related to relevant non-clinical performance and "acceptance criteria" where applicable to this physical device, as described in the document.

Acceptance Criteria and Device Performance for Kitazato ET Catheters (Physical Device)

This submission focuses on demonstrating substantial equivalence of a physical medical device (embryo transfer catheters) to a predicate device, primarily through non-clinical performance data. Therefore, the "acceptance criteria" are related to established norms for medical device safety and performance rather than AI-specific metrics like AUC, sensitivity, or specificity in a diagnostic context.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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SepaSperm Washing Solution is used for preparation and washing of sperm for use in assisted reprocedures. SepaSperm Washing Solution is not intended for use in intrauterine insemination procedures.

SepaSperm Solution is used for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.

SepaSperm is used for preparation and washing of sperm and for separation of motile sperm from semen in assisted reproductive techniques.

The device includes two types of solutions used for density-gradient centrifugation:

• . SepaSperm Solution for sperm preparation and separation from semen, and
• . SepaSperm Washing Solution for sperm washing and preparation

Both solutions are provided in two sizes (100mL and 50mL bottles). This product is single-use only and includes no accessories. The provided sterile-filtered into a container that is sterilized by gamma irradiation.

SepaSperm Solution is offered in four different densities, determined by the amount of silica present:

• SepaSperm Solution 100% -
• -Lower laver solution 80%
• Middle layer solution 60% -
• -Upper layer solution 40%

SepaSperm Solution is composed of silica particles diluted with modified human tubal fluid (m-HTF) medium, with dextran and polyvinylpyrrolidone added. The m-HTF medium is a HEPES-buffered solution which is suitable for use in ambient conditions. All SepaSperm Solutions are provided with and without gentamicin. SepaSperm Solution has a shelf-life of six or 12 months for media without or with gentamicin, respectively.

The SepaSperm Washing Solution consists of m-HTF medium supplemented with dextran and polyvinylpyrrolidone. It contains no silica. SepaSperm Washing Solution is used to wash the prepared sperm and suspend the final pellet. SepaSperm Washing Solutions are provided with and without gentamicin. SepaSperm Washing Solution has a shelf-life of six or 12 months for media without or with gentamicin, respectively.

The provided text describes the acceptance criteria and a "Summary of Non-Clinical Performance Testing" for the SepaSperm Washing Solution and SepaSperm Solution, which are reproductive media. This document is a 510(k) summary for a medical device submitted to the FDA, indicating a comparison to a predicate device.

Here's the breakdown of the information requested:

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

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size for individual tests (e.g., how many batches for shelf-life, how many sperm samples for HSSA or separation effectiveness) or the provenance (country of origin, retrospective/prospective nature) of the non-clinical performance test data. It only states that "The following studies have been performed to support substantial equivalence to the predicate devices."

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 listed are laboratory performance tests for the media itself, not clinical studies involving expert interpretation of medical images or patient data.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided, as the studies are described as non-clinical performance testing of a medical device (media), not human-read clinical data requiring adjudication.

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:

This information is not applicable and therefore not provided. This is a 510(k) submission for reproductive media, not an AI-powered diagnostic device.

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

This information is not applicable and therefore not provided. This is a medical device (culture media), not an algorithm.

7. The type of ground truth used:

The "ground truth" for the performance testing of these media solutions is based on established laboratory standards and specifications (e.g., USP for pH, USP for osmolality, USP for endotoxin, USP for sterility, ISO 13408 standards for sterile filtration, ASTM D4169 for transportation, USP for container performance). For sperm assessment, the "ground truth" would be the initial characteristics of the sperm samples and their characteristics after processing, compared against expected physiological ranges and performance standards.

8. The sample size for the training set:

This information is not applicable and therefore not provided. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

This information is not applicable and therefore not provided for the reason stated in point 8.

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Cryotop®US-flash and Cryotop®US-scoop are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos.

This 510(k) covers two subject devices, the Cryotop®US-flash and Cryotop®US-scoop that are modified versions of the predicate device (Cryotop®US, K153027). Both devices are cryopreservation storage devices intended for embryo/oocyte vitrification. Cryotop®US-flash and Cryotop®US-scoop are provided sterile and are for single-use only.

The Cryotop®US-flash is composed of a polypropylene straw and an acrylonitrile butadiene styrene handle with a polyethylene terephthalate fine tip where oocytes or embryos are loaded. The fine device is flat with a triangular-shaped area for oocyte/embryo loading. The Cryotop®US-scoop is composed of a polypropylene straw and a polystyrene handle and fine tip where oocytes or embryos are loaded. The fine tip of this device is U-shaped. After oocyte or embryo loading, the handle of the subject devices is inserted into the straw enclosure. A hermetic seal is created via a tapered handle with a stop location integrated into the handle. As the handle is placed into the straw enclosure it creates a closed system keeping the fine tip isolated from the liquid nitrogen. The straw component of both devices also includes a weight at its distal end to aid in maintaining correct device position during storage in liquid nitrogen.

The provided text describes a 510(k) premarket notification for two new cryopreservation storage devices: Cryotop®US-flash and Cryotop®US-scoop. The submission aims to demonstrate substantial equivalence to a predicate device, Cryotop®US (K153027). The document focuses on non-clinical performance data to support this claim, rather than a clinical study comparing the devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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Cumulus Remover is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

Cumulus Remover is an enzyme solution containing recombinant human hyaluronidase that digests hyaluronic acid that binds the cumulus and corona cells surrounding oocytes together. This function of hyaluronidase can be used for denuding cumulus and coronal cells from oocytes prior to performing Intracytoplasmic Sperm Injection (ICSI) fertilization procedures. Cumulus Remover is provided in a polypropylene vial (package size 0.5 mL), and five vials are packaged together in a box. This product is aseptically processed and has a shelf-life of six months when stored at 2-8°C. Cumulus Remover is tested for pH, osmolality, endotoxin, sterility, embryotoxicity, and hyaluronidase activity before lot release.

The provided text describes the "Cumulus Remover," a hyaluronidase solution used for removing cumulus complex and corona radiata from oocytes in preparation for ICSI. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

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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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The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine in vitro fertilisation.

Kitazato ET Catheters are sterile, single-use catheters for embryo transfer. The ET Catheters consist of a transfer catheter, guide catheter, and a stylet sheath. The Transfer catheter (hereafter referred to as 'catheter' or 'ET Catheter') is composed of a catheter shaft, a connector and a shaft protective sleeve (protector). The catheter types include a normal catheter (Type1, EC-PRO Normal), a catheter with a stainless outer stiffener (Type2, EC-PRO Supported), a catheter with Echo Line (Type3, EC-PRO Master), and a catheter that has both the stainless outer stiffener and the echo line (Type4, EC-PRO Master Supported), all of which are offered in lengths of 18cm and 23cm, and various versions (v1-v8). A corresponding Trial catheter of the same length is provided for all four Types of the Kitazato ET Catheters. The Guide catheter is offered both with a straight shaft and a 30° pre-curved distal shaft. The Stylet Cannula (Type5) is an optional accessory used when additional rigidity is needed during insertion of the cannula through the cervix, and is offered in two lengths, 13.5 cm and 18.5 cm.

During the implantation procedure of the embryo into the uterus, the catheter is introduced into the uterine cavity through the cervix, then the embryo is delivered into the uterine cavity by plunging the syringe that is coupled at the connector end of the catheter via a 6% taper luer lock. A syringe is not included with the Kitazato ET Catheters.

The provided text describes the Kitazato ET Catheters, an embryo transfer catheter, and its substantial equivalence to a predicate device. It includes non-clinical performance data to support its safety and effectiveness.

Here's the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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