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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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PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.

Phosphate Buffered Saline [PBS(-)] is a colorless isotonic buffered solution with a pH of 7.20-7.60.
PBS(-) composition:

• Sodium Chloride
• · Potassium Chloride
• Monopotassium phosphate
• Di-sodium Hydrogen Phosphate Anhydrous
  PBS(-) will be available in volumes of 100mL and 500mL. Packaging for PBS(-) consist of a PETG (Polyethylene Terephtalate Glycol-modified) bottle and HDPE (High Density Polyethylene) cap. PBS(-) has a six-month shelf-life.

This document is a 510(k) premarket notification for a reproductive media called "PBS(-), Phosphate Buffered Saline" by KITAZATO BioPharma Co., Ltd. It outlines the device's description, indications for use, and a comparison to a predicate device, along with performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

Mineral Oil is used to cover medium during embryo, oocyte, and sperm culture in assisted reproduction technology (ART) and micro-manipulation procedures. Mineral Oil is recommended for use as an overlay for a small volume of medium to prevent evaporation stable osmolality and pH.

The material composition:

High Purity Paraffin Oil comes in two density types:

• Light type has a ratio between 0.8200 to 0.8400 g/mL (15°C) and a viscosity which is between 8.850 to 11.70mm²/s (37.78°C)
• Heavy type has a ratio between 0.8500 to 0.8700 g/mL (15°C) and a viscosity which is between 41.90 to 44.10mm²/s (37.78°C).

There are two types of products, Mineral Oil - Light and Mineral Oil - Heavy. Two different unit sizes (100mL and 50mL) are available for each type. Mineral oils are colorless, tasteless, clear oil fluids which do not produce fluorescence.

Both Mineral Oils (Heavy and Light) do not contact the ova or embryo during culture. Mineral Oil is filter sterilized and dispensed into sterile light-resistant glass bottles.

The provided text describes a 510(k) premarket notification for a medical device called "Mineral Oil" used in assisted reproductive technology. This is not the type of document that typically includes information about acceptance criteria and a study proving the device meets those criteria, as one would find for a software-based AI/ML medical device.

The document is a US FDA 510(k) clearance letter and summary for a physical product (Mineral Oil) which functions as a reproductive media supplement. It aims to demonstrate "substantial equivalence" to a predicate device rather than independently proving safety and efficacy through extensive clinical studies and AI performance metrics.

Therefore, many of the requested categories for acceptance criteria and study details for an AI/ML device are not applicable or cannot be extracted from this document. However, I can extract the "non-clinical performance data" which serves as the "acceptance criteria" and "device performance" for this specific product, as well as some details about its testing.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available:

1. Table of Acceptance Criteria and Reported Device Performance & 7. The type of ground truth used:

The acceptance criteria for this non-AI/ML device are based on non-clinical performance tests designed to establish substantial equivalence concerning safety and effectiveness. The "ground truth" here is essentially the compliance with these established biological and chemical specifications.

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

The document does not specify exact sample sizes for each non-clinical performance test. It only states that tests were completed. Data provenance is not detailed beyond the manufacturer being "KITAZATO BioPharma Co., Ltd." in Japan. The tests are non-clinical (laboratory-based), not human data, so "retrospective or prospective" does not apply in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the "ground truth" for these non-clinical tests is based on established laboratory standards (e.g., USP , ), chemical specifications, and biological assay outcomes, rather than expert interpretation of medical images or patient data.

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

Not applicable for non-clinical laboratory tests.

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 applicable. This is for a physical medical device (mineral oil), not an AI/ML device.

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

Not applicable. This is a physical product, not an algorithm.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set. The "device" itself is the mineral oil which is manufactured according to specifications.

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

Not applicable. This is not an AI/ML device.

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The Cryotop®US is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

CryotopUS is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopUS device for subsequent storage.

The CryotopUS device is composed of an acrylonitrile butadiene styrene (ABS) handle shaft with a polyethylene terephthalate (PET) film tip and a polypropylene straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopUS device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The handle shaft is designed with a "stop" for inserting the film tip/shaft handle into the straw enclosure. A hermetic seal is created via a tapered shaft handle with a stop location integrated into the handle is placed into the straw enclosure this creates a closed system keeping the film tip isolated from the liquid nitrogen. The straw enclosure system has a weight at the distal end to place the straw and the shaft inside in a correct position in the liquid nitrogen. The CryotopUS device is provided sterile and is for single use only. The CryotopUS device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.

The provided document describes the performance testing of the Cryotop®US cryopreservation storage device. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size used for each "test set." It mentions that the performance testing, Mouse Embryo Assay (MEA), and sterility tests are "all performed on samples from routine manufactured lots." This suggests that the testing is ongoing quality control rather than a single, fixed sample size for a specific study.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. Given that it's for a new device attempting to prove substantial equivalence, the testing would generally be prospective, conducted by the manufacturer (KITAZATO BioPharma Co., Ltd. from JAPAN).

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 tests performed are objective physical and biological assays (e.g., cooling rate, biochemical levels, embryonic development), and their results are typically assessed against pre-defined numerical thresholds or standards rather than expert consensus on a "ground truth" as might be seen for diagnostic imaging interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the acceptance criteria are based on objective measurements and established standards, not on subjective interpretations by multiple experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance data comparing the device to a predicate device based on technical characteristics and objective performance tests, not human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (cryopreservation storage device), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

• Established Standards/Specifications: For parameters like cooling/warming rates, dimensional requirements, tensile strength, endotoxin levels, and sterility, the ground truth is defined by pre-determined numerical specifications or industry standards that the device must meet.
• Biological Outcomes: For the Mouse Embryo Assay, the ground truth is the successful development of embryos to a certain stage (≥80% of 1-cell control embryos develop at 96 hours), which is a direct biological efficacy measure.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a physical medical device and does not involve machine learning or AI, thus there is no "training set."

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

This information is not applicable/not provided as there is no training set for this type of device.

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The Cryotop®SC is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

CryotopSC is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. Extracting embryos from the body can be costly and burdensome process for the patient to go through multiple extraction procedures. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopSC device for subsequent storage.

The CryotopSC device is composed of an ABS handle shaft with a PET fine tip and a straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopSC device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The straw cap is designed to be heat sealed by the user. The straw cap has a weight at the distal end to place the straw cap and the shaft inside of the cap in a correct position in the liquid nitrogen. The CryotopSC device is provided sterile and is for single use only. The CryotopSC device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.

The Aluminum Block is required for use with the CryotopSC device for the vitrification and thawing process and is sold separately. The Aluminum Block is to be used with the CryotopSC device to prevent liquid nitrogen from entering the straw and to assist in stabilizing the manipulation of the straw.

The CryotopSC device conforms to product quality test specifications of our company: appearance, dimension, durability, tensile strength, colorfastness, endotoxin and Mouse Embryo Assay. The sterilization dose of CryotopSC is validated by sterilization to maintain the sterility of the device through anticipated storage and handling.

The provided text describes the 510(k) submission for the Cryotop®SC cryopreservation storage device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than a study proving the device directly meets acceptance criteria in a clinical context with human users.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the performance testing, Mouse Embryo Assay (MEA), and sterility tests are “all performed on samples from routine manufactured lots”. It does not specify a particular sample size for each test, nor does it provide details on data provenance such as country of origin. The data is retrospective in the sense that it's performed on manufactured lots, but the context is pre-market submission.

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

This information is not applicable/not provided in the document. The Cryotop®SC is a physical device for cryopreservation, and its performance is evaluated through material and biological tests, not by human expert assessment of a test set in the way a diagnostic AI would be. The "ground truth" for these tests is based on established scientific and manufacturing standards (e.g., specific cooling/warming rates, mechanical strength thresholds, endotoxin limits, embryo development rates).

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 typically apply to studies where multiple human readers interpret data, and their findings need to be reconciled to establish a ground truth. Since this device is evaluated through objective physical and biological tests, such an adjudication method is not relevant.

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/not provided. The Cryotop®SC is a physical medical device (cryopreservation storage device) and not an Artificial Intelligence (AI) or software as a medical device (SaMD) that would typically be evaluated in an MRMC study related to human reader performance or AI assistance.

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

This information is not applicable/not provided. As explained above, the Cryotop®SC is a physical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The ground truth used for the performance testing includes:

• Quantitative Thresholds/Specifications: For cooling rate, warming rate, dimensional compliance, mechanical tensile strength, and endotoxin levels. These are objective numerical values that the device must meet.
• Absence of Growth/Contamination: For sterility testing (absence of microbial growth).
• Biological Viability Percentage: For the Mouse Embryo Assay (MEA), typically defined as a certain percentage of embryos reaching a specific developmental stage (≥80% of 1-cell control embryos develop at 96 hours). This is a biological "ground truth" established through a standard assay.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Cryotop®SC is a physical device, and its development does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing are based on engineering principles and material science.

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

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

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The Cryotop®CL is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

CryotopCL is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

The CryotopCL device is composed of PET plastic shaft with a fine tip and a straw cap. The fine tip has 5 rounded depressed areas for loading embryos. The CryotopCL device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The straw cap is designed to be heat sealed by the user. The protective straw cap has a weighted end to allow proper alignment in the storage container. The CryotopCL device is provided sterile and is for single use only. The device is also provided with a pushing straw to aid in loading the sample holding component of the device into the "straw" enclosure system.

The CryotopCL device conforms to product quality test specifications of our company: appearance, dimension, durability, tensile strength, colorfastness, endotoxin and Mouse Embryo Assay. The sterilization dose of CryotopCL is validated by sterilization validation to maintain the sterility of the device through anticipated storage and handling.

Acceptance Criteria and Device Performance Study for Kitazato's Cryotop®CL

This document describes the acceptance criteria and the study used to demonstrate that Kitazato's Cryotop®CL device met these criteria, based on the provided 510(k) summary (K112695).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of devices tested for cooling rate, endotoxin, etc.). However, it indicates:

• Test Set Description: The "Non-Clinical Testing" section lists various tests performed on the CryotopCL device.
• Sample Size: Not explicitly stated as a single number for all tests. For the Mouse Embryo Assay, the acceptance criteria relates to the percentage of 1-cell control embryos that develop, implying a sample of embryos within a test.
• Data Provenance: Retrospective, as the testing was performed during the development and validation phase of the device prior to submission. The origin of the data is from KITAZATO BioPharma Co., Ltd. in Japan, as they are the submission sponsor and manufacturer.

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

The document does not mention the use of external experts or a ground truth panel to establish the "ground truth" for the non-clinical performance tests. The tests performed are objective, quantitative measurements (e.g., temperature rates, physical dimensions, endotoxin levels, sterility checks) or standardized biological assays (Mouse Embryo Assay). These types of tests typically rely on established protocols and measurement standards rather than expert consensus on a "ground truth" definition for individual cases.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the non-clinical tests are objective and quantitative; therefore, an adjudication method for conflicting expert opinions is not relevant. The results are compared directly against predefined numerical or qualitative acceptance criteria.

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

No MRMC comparative effectiveness study was done. The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices." Therefore, no study involving human readers (with or without AI assistance) was conducted to assess improvement.

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

Not applicable. The Cryotop®CL is a physical medical device (cryopreservation storage device) and not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by:

• Predefined physical specifications: For dimensional and mechanical tests.
• Established scientific thresholds: For cooling/warming rates, endotoxin levels, and sterility (e.g., no microbial growth, SAL 10^-6^).
• Standardized biological assay outcomes: For the Mouse Embryo Assay, the ground truth is the viability/development of 1-cell control embryos at 96 hours as observed in the assay.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning system that requires a training set.

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

Not applicable, as there is no training set for this device.

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