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Dewin Gamete Buffer is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).

Dewin Follicle Flushing Solution is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

Dewin One Step Medium is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.

The DonneVie Dewin Reproductive Media are solutions used in assisted reproductive procedures. The family of Reproductive Media include the following 3 types and their variants:

• Dewin Gamete Buffer [with and without Human Serum Albumin (HSA)];
• Dewin Follicle Flushing Solution;
• Dewin One Step Medium [with and without HSA].

All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. The Gamete Buffer and Follicle Flushing media are offered in 100mL volume, while the One Step Medium is offered in volumes of 25mL and 50mL. The three Dewin Reproductive Media are used together during an assisted reproductive procedure. The Follicle Flushing Solution is used to first flush/wash the Cumulus-Oocyte Complex after it's removed from the ovary; it is then transferred to the Gamete Buffer for cleaning. After the prepared oocyte has been fertilized, it is transferred to the One Step Medium to culture the embryo from fertilization to blastocyst stage.

The primary glass bottle containers are washed, then sterilized and depyrogenated via dry heat. The bottle caps are supplied sterile by electron beam irradiation. The media are sterile filtered through a 0.2µm filter in an aseptic isolator at DonneVie Medical Technology Co., Ltd.

The provided FDA 510(k) clearance letter describes a medical device called "Dewin Reproductive Media" and presents non-clinical performance testing to demonstrate its substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dewin Reproductive Media are primarily derived from the specifications compared to the predicate device and the results expected from specific non-clinical tests.

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

The document does not specify the exact sample sizes for most of the non-clinical tests conducted. For example, it doesn't state how many batches were tested for sterility, pH, osmolality, or endotoxin, nor does it specify the number of mouse embryos used in the MEA tests.

• Provenance: The studies were conducted by DonneVie Medical Technology (Shanghai) Co. Ltd. This implies the data provenance is likely from China, as that is the submitter's location. The studies are non-clinical, meaning they are laboratory tests, not human trials. They are implicitly prospective in the sense that they were designed and executed to test the device's performance against predefined criteria.

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

This section is not applicable as the studies described are non-clinical laboratory tests, not studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests (e.g., pH value, osmolality, microorganism presence, blastocyst development) is established through established laboratory methods and validated instrumentation, not by expert consensus in a clinical diagnostic context.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly in cases where human readers or diagnosticians are involved and their interpretations need to be reconciled to establish a ground truth. For laboratory tests, the results are typically quantitative or qualitative outcomes determined by a predefined method, eliminating the need for expert adjudication in this typical sense.

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 section is not applicable. The device is a "Reproductive Media," which are solutions used in assisted reproductive procedures (e.g., for washing gametes, culturing embryos). It is not an AI-powered diagnostic device or an imaging system. Therefore, no MRMC study involving human readers or AI assistance would be relevant or conducted for this type of product.

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

This section is not applicable. The device is a reproductive media solution, not an algorithm or an AI system. Its performance is evaluated through physical, chemical, and biological laboratory tests, not through algorithmic output.

7. The Type of Ground Truth Used

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

• Physicochemical Measurements: For parameters like pH, osmolality, and endotoxin, the ground truth is the numerical value obtained using validated analytical instruments and methods (e.g., pH meter, osmometer, LAL assay).
• Biological Endpoints: For the Mouse Embryo Assay (MEA), the ground truth is the observed development of mouse embryos to the expanded blastocyst stage within a specified timeframe, as assessed under a microscope by trained personnel following a standardized protocol.
• Microbiological Endpoints: For sterility testing, the ground truth is the absence of microbial growth in culture, determined by standard microbiological techniques.
• Regulatory Standards: Compliance with ISO standards for sterilization, biocompatibility, and transportation testing.

8. The Sample Size for the Training Set

This section is not applicable. The Dewin Reproductive Media is a chemical/biological product, not a machine learning model or AI system that requires a "training set." The product's formulation and manufacturing processes are developed through research and development, not by training an algorithm on a dataset.

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

This section is not applicable as there is no "training set" for this type of device.

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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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FertiCult™ Flushing medium are intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult™ Flushing medium can also be used human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity. The medium is NOT intended for oocyte pick-up and follicle flushing. FertiCult Flushing medium is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.

FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult Flushing media can also be used for human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity.

The base formulation contains Water, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Sulphate Heptahydrate, Sodium Dihydrogen Phosphate Dihydrate, Sodium Pyruvate, Glucose Monohydrate, Sodium Lactate, Sodium hydrogen carbonate, HEPES, Human Serum Albumin.

A FertiCult Flushing media variant contains Phenol red and Gentamicin.

The products can be used up to 7 days after opening, when sterile conditions are maintained, and the products are stored at 2-8°C.

The provided FDA 510(k) clearance letter pertains to the FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin. This document demonstrates the substantial equivalence of the new device to a predicate device, as required for FDA clearance.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed are primarily for the physical, chemical, and biological properties of the media, ensuring its quality and suitability for use in Assisted Reproductive Technology (ART) procedures.

• Historically accepted biological performance indicators: Mouse Embryo Assay (MEA) results (development to expanded blastocyst), as specified by the 2021 FDA guidance.
• Observed physical and chemical characteristics: Absence of precipitates.

These are objective, quantifiable, or universally accepted biological endpoints, rather than expert consensus on a subjective interpretation.

8. The Sample Size for the Training Set

Not applicable. This device is a culture medium, not an AI/ML algorithm that requires a training set. The performance testing described validates the manufacturing quality and biological compatibility of the product.

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

Not applicable, as this is not an AI/ML device requiring a training set.

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

Vitrification Thaw 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.

The Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos during the in vitro assisted reproduction. The Vitrification Freeze Kit includes two solutions: Equilibration Solution (ES) and Vitrification Solution (VS). Both solutions contain ethylene glycol, dimethyl sulfoxide (DMSO), human serum albumin, and Quinn's Advantage® Medium with HEPES. The VS also contains additional sucrose to confer intracellular and extracellular cryoprotective effects. The solutions are available in three specifications: 2 mL, 4.5 mL, and 5 mL, all packaged in polypropylene (pp) vials. The kit includes one vial of each solution.

The Vitrification Thaw 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 during in vitro assisted reproduction. The Vitrification Thaw Kit includes 4 solutions: Thawing Solution 1 (TS1), Thawing Solution 2 (TS2), Thawing Solution 3 (TS3), and Thawing Solution 4 (TS4). All four solutions contain human serum albumin and Quinn's Advantage® Medium with HEPES. TS1 and TS2 also contain sucrose. The solutions are available in three specifications: 2 mL, 4.5 mL, and 5 mL, and 5 mL, all packaged in polypropylene (pp) vials. Model RFD-0201 includes one vial of each solution in the kit, and Model RFD-0202 contains two vials of TS1 and one vial of TS2, TS3, and TS4 each in the kit.

The provided FDA 510(k) clearance letter and summary describe the Vitrification Freeze Kit (RFD-0101) and Vitrification Thaw Kit (RFD-0201, RFD-0202) manufactured by Jiangsu Ruifuda Medical Device Co., Ltd. This device falls under the classification of Reproductive Media and Supplements (Regulation Number: 21 CFR 884.6180, Product Code: MQL).

This document focuses on the in vitro performance of the device rather than a clinical study involving human readers or a standalone AI algorithm. Therefore, many of the typical acceptance criteria and study elements associated with AI-driven medical devices (like MRMC studies, ground truth established by expert consensus, and human reader performance improvement) are not applicable here.

The device's performance is demonstrated through a series of non-clinical performance tests designed to show that it meets specific quality and functional criteria, ensuring its safety and effectiveness for its intended use in assisted reproduction.

Here's a breakdown of the acceptance criteria and study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The device's performance was assessed against specific product specifications through shelf-life testing. The criteria are outlined below:

Study Details

1. Sample size used for the test set and data provenance:
   This is not a clinical study involving a "test set" in the traditional sense of patient data. The "samples" refer to batches of the manufactured media. The document doesn't specify the exact number of batches or vials tested for each assay (e.g., how many vials for pH, how many embryos for MEA).

   • Data Provenance: The studies were conducted by the manufacturer, Jiangsu Ruifuda Medical Device Co., Ltd., in China, as indicated by the contact details. The data is prospective, generated from testing the manufactured product.

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. The "ground truth" for this in vitro diagnostic/media device is established by the results of standardized laboratory assays (pH, osmolality, endotoxin, sterility, and Mouse Embryo Assay), not by expert human interpretation of images or observations. These assays have predefined acceptance criteria based on scientific and regulatory standards (e.g., USP and ISO standards).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as no human interpretation requiring adjudication was involved. The tests are quantitative laboratory measurements.

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 device is a vitrification and thawing media kit, not an AI or imaging device that would involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. There is no algorithm involved with this device. Its performance is chemical and biological.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for this device's performance is based on standardized laboratory assay results and biological functionality (specifically, the Mouse Embryo Assay, which demonstrates the media's ability to support embryo development). These methods are scientifically accepted ways to assess the quality and performance of reproductive media.

7. The sample size for the training set:
   Not applicable. This device does not involve a "training set" for an algorithm. Its development and validation are based on chemical formulation and in-house laboratory testing.

8. How the ground truth for the training set was established:
   Not applicable. No "training set" as understood in a machine learning context. The product formulation and manufacturing processes are established through standard chemical and biological development protocols, and validated against the performance criteria listed above.

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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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CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.

CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus.

CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transfering to the uterine cavity.

CaseBioscience® HTF w/HEPES is intended for use in short-term handling gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavitv.

CaseMONO Culture, CaseMONO w/HEPES, CaseBioscience HTF, and CaseBioscience HTF w/HEPES are intended for use during in vitro procedures for gamete/embryo culture and one step media.

CaseMONO Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device is a one-step media and can be used for transfer of embryos to the uterus.

CaseMONO w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).

CaseBioscience HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device is not a one-step medium but can be used for transfer of embryos to the uterus.

CaseBioscience HTF w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).

CaseMONO Culture and CaseMONO w/HEPES have almost identical composition with differences in amount of NaHCO3 and Phenol red and presence of HEPES in CaseMONO w/HEPES. Similarly, CaseBioscience HTF and CaseBioscience HTF w/HEPES have an almost identical composition with the exception of HEPES present in CaseBioscience HTF w/HEPES and minor difference in composition for NaCl, Sodium L-lactate and Phenol red. CaseMONO Culture and CaseMONO w/HEPES contain EDTA. All media formulations contain antibiotic gentamicin.

The four solutions are aseptically filtered (storage vials sterilized by radiation) and provided in PETG square media bottles with HDPE screw-style caps. They have a shelf-life of 90 days when stored at 2-8°C. Media in the vials can be used for up to seven days after vial opening.

Acceptance Criteria and Device Performance Study for CaseBioscience Assisted Reproduction Media

This document outlines the acceptance criteria and the study conducted to prove that the CaseBioscience® Assisted Reproduction Media (CaseMONO™ Culture, CaseMONO™ w/HEPES, CaseBioscience® HTF, and CaseBioscience® HTF w/HEPES) meet these criteria, as detailed in the K242107 510(k) Summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each variant of the CaseBioscience Assisted Reproduction Media are based on various non-clinical performance tests. The reported device performance met these acceptance criteria.

2. Sample Size and Data Provenance

The provided document details non-clinical performance testing for assisted reproduction media. The sample sizes for each specific test (e.g., number of embryos in MEA, number of samples for pH/Osmolality) are not explicitly stated in this summary.

The data provenance is from non-clinical laboratory testing and is retrospective in nature, as it was conducted to support a 510(k) submission for an existing product. The country of origin of the data is not specified, but the testing would have been conducted by or for CaseBioscience, Inc., which is based in Canada.

3. Number of Experts and Qualifications for Ground Truth

This submission pertains to in vitro reproductive media. The ground truth for performance (e.g., embryo development, chemical properties, sterility) is established through standardized laboratory assays and specifications, rather than expert human interpretation of images or patient data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis by multiple medical professionals is not applicable here. The "experts" would be the scientists and quality control personnel in the laboratory performing the assays, adhering to validated methods.

4. Adjudication Method for the Test Set

As the evaluation is based on objective laboratory measurements and standardized assays (e.g., pH meters, osmometers, bacterial growth cultures, embryo development rates), an "adjudication method" in the sense of a consensus process among human readers (e.g., 2+1, 3+1) is not applicable. The results are quantitative and binary (pass/fail against a threshold).

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

An MRMC comparative effectiveness study is typically performed for AI/CADe systems where human readers interpret medical images. Since this submission is for in vitro assisted reproduction media, which do not involve human interpretation of images or AI assistance in the diagnostic process, an MRMC comparative effectiveness study was not performed. Therefore, effect size of human improvement with AI assistance is not relevant or measurable in this context.

6. Standalone (Algorithm Only) Performance Study

This submission is for a medical device that is a consumable media, not a software algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance is assessed based on the physical, chemical, and biological properties of the media itself.

7. Type of Ground Truth Used

The ground truth used for proving the device meets the acceptance criteria is based on:

• Laboratory-established specifications and thresholds: For parameters like pH, osmolality, bacterial endotoxin, and appearance.
• Standardized biological assays: Specifically, the Mouse Embryo Assay (MEA), where the "ground truth" for success is a predefined percentage of embryos reaching a certain developmental stage (expanded blastocyst) within a specified timeframe.
• Compliance with international standards: For sterilization, aseptic processing, and biocompatibility testing (e.g., ISO, USP, ASTM).

8. Sample Size for the Training Set

This product is an in vitro medical device, not an AI/ML software. Therefore, there is no "training set" in the context of machine learning model development. The product is manufactured and tested according to established quality control procedures and specifications.

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

Since there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the performance of the media is established by validated laboratory methods and industry/regulatory standards.

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V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.

V-GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes that is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures. Available as a 100 % stock solution (V-GRAD 100) and as 40% or 80% ready-to-use solutions (V-GRAD 40 and V-GRAD 80) with HEPES buffered Human Tubular Fluid (HTF) medium. V-GRAD 100 is a stock solution for preparing a density gradient system for semen preparation. The V-GRAD Kit consists of two bottles of V-GRAD 40 and V-GRAD 80. V-GRAD is aseptically filtered and provided in pre-sterilized 12 mL glass bottles closed with flourotec rubber stoppers and flip-tear off caps or 100 mL PET(G) bottles closed with HDPE screw caps. V-GRAD has a shelf-life of one year when stored at 2-8°C and can be used for up to seven days after bottle opening.

The provided text describes the regulatory clearance of a medical device, V-GRAD, which is a reproductive medium used for sperm separation. It outlines the device's technical specifications and compares them to a legally marketed predicate device (ORIGIO Gradient). However, the document primarily focuses on non-clinical performance testing to support substantial equivalence and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop system.

The device, V-GRAD, is a laboratory reagent (colloidal suspension for density gradient sperm separation), not an AI-powered diagnostic or assistive tool. Therefore, the concepts of "acceptance criteria" and "study" as typically applied to AI-driven medical devices (e.g., using a test set, expert ground truth, MRMC studies, standalone performance) are not applicable to the V-GRAD submission as described.

The "performance testing" mentioned in the document refers to traditional lab-based tests for reproductive media:

• Aseptic filtration and aseptic filling validation: Ensures the sterility of the manufacturing process.
• Shelf-life testing: Verifies that the product maintains its specifications (appearance, pH, osmolality, endotoxin, density, Human Sperm Survival Assay (HSSA), sterility) over its stated shelf life after accelerated aging and simulated use.
• Transportation testing: Ensures the product integrity during shipping.
• Sperm evaluation: Confirms that sperm separated using the device exhibit comparable motility, morphology, and purity to those separated with the predicate device.

Since the prompt asks for details related to AI/human-in-the-loop medical device evaluation, and the provided text does not describe such a device or study, I cannot fulfill the request using only the given input.

Therefore, for each point, the answer will be "Information not available in the provided text" or "Not applicable as the device is not an AI/human-in-the-loop system."

Based on the provided text, here is the information:

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

   • Acceptance Criteria and Reported Device Performance: The document lists "product specifications" that are met during shelf-life testing, which implicitly serve as acceptance criteria for the quality and performance of the medium itself. These are not performance metrics for an AI system.

     Criteria/Specification	Acceptance Limit (Implied)	Reported Performance (Implied, "met specifications")
     Appearance	Pink rose (V-GRAD 40), light pink (V-GRAD 80), colorless (V-GRAD 100)	Met
     pH	7.2-7.9	Met
     Osmolality (mOsm/kg)	310-340 (V-GRAD 40/80), 300-330 (V-GRAD 100)	Met
     Endotoxin (EU/mL)	)	No growth
     Sperm Evaluation (Motility, Morphology, Purity)	Comparable performance with predicate device and other cleared devices	Demonstrated comparable performance
     Shelf-Life	1 Year	Supported (met specifications at time 0 and after accelerated aging)

2. Sample sizes used for the test set and the data provenance: Information not available in the provided text. The studies described are non-clinical lab tests of the medium itself, not a clinical test set for an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the device is not an AI/human-in-the-loop system requiring expert-adjudicated ground truth. The "ground truth" for V-GRAD's performance is established by standardized laboratory assays (e.g., pH meters, osmometers, endotoxin testing, HSSA).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as the device is not an AI/human-in-the-loop system.

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 as the device is not an AI/human-in-the-loop system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is not an AI/human-in-the-loop system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance of the V-GRAD medium, the "ground truth" is defined by established laboratory methods and controls for measuring characteristics like pH, osmolality, sterility, and the biological response in an HSSA. For "Sperm separated using the subject device were evaluated for motility, morphology, and purity," the ground truth would be the measurement outcomes from standard semen analysis techniques, compared to controls (predicate device or other cleared devices).

8. The sample size for the training set: Not applicable as the device is not an AI/machine learning system.

9. How the ground truth for the training set was established: Not applicable as the device is not an AI/machine learning system.

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Sperm Freezing Medium is intended for the cryopreservation of human semen samples to sperm samples during cryopreservation and thawing prior to use in assisted reproductive technology procedures.

Not Found

I am sorry, but based on the provided text, there is no information available about the acceptance criteria or a study proving that a device meets such criteria.

The document is an FDA 510(k) clearance letter for a device named "Sperm Freezing Medium." This letter confirms that the device is substantially equivalent to a legally marketed predicate device. It discusses regulatory requirements, such as general controls, quality systems, and UDI, but it does not include any details about performance criteria or studies conducted by the manufacturer to demonstrate the device's performance.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size.

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ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).

ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).

ARTSMedia Semen Wash Medium consists of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water.

Furthermore, ARTSMedia Semen Wash Medium is aseptically filtered and provided in a volume of 20 mL. 50 mL. and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Semen Wash Medium is tested for pH, osmolality, endotoxin, sterility, and sperm toxicity before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.

The provided text describes a 510(k) premarket notification for a medical device called "ARTSMedia Semen Wash Medium." It compares the new device to a predicate device and presents non-clinical performance testing. However, the document does NOT contain information about a study involving an AI/Machine Learning enabled device, human readers, or the establishment of ground truth for such a study. Therefore, I cannot extract the requested information regarding acceptance criteria and study proving device performance for an AI/ML device.

The document is solely about a reproductive media and supplements device and its substantial equivalence based on physical and chemical properties and biocompatibility, not an AI/ML diagnostic or assistive device.

Therefore, for all the requested information, the answer will be "Not applicable / No information provided in the given text."

Here's a breakdown of why based on the input text:

1. A table of acceptance criteria and the reported device performance: The document provides a table comparing characteristics like pH, Osmolality, Human Sperm Survival Assay, and Endotoxin for the subject and predicate devices. These are "performance" metrics for a biological solution, but not for an AI/ML device's diagnostic accuracy or similar.

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