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The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.

Geri Connect and Geri Assess are optional software accessories for the Geri Embryo Incubator. Geri Connect is intended for access and review of time-lapse data generated by the Geri Embryo Incubator on a local area network. Geri Assess is intended for viewing and recording embryo development events from images captured using the Geri Embryo Incubator. Geri Assess includes a user annotation for capturing information on embryo development parameters and a userdefined modeling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection. Geri Connect and Geri Assess do not control any hardware components in the Geri Embryo Incubator. Geri Connect and Geri Assess are combined in the same software package and must be used together.

The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.

The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders. The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.

The Geri Assess and Geri Connect are optional software accessories for the Geri Embryo Incubator. The Geri Connect allows the user to access the embryo data remotely, whereas the Geri Assess provides the user with a tool for analysis of embryo data. Using user defined parameters, the Geri Assess can score the embryos. However, the Geri Assess itself does not include any pre-loaded scoring assessments or perform any diagnostic functions. The Geri Connect and Geri Assess software package is provided with the Geri Embryo Incubator, but needs to be unlocked, when purchased by the end user.

The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. Up to 16 embryos can be stored in one Geri Dish. Geri Dishes are supplied sterile with a sterility assurance level (SAL) of 10 %, and have a shelf-life of 12 months. The Geri Dish is intended to be used only with the Geri Embryo Incubator. Other assisted reproduction culture dishes may be used in the Geri Embryo Incubator in separate non-time-lapse positions located within each chamber.

The provided text is a 510(k) summary for the Geri Embryo Incubator with Geri Connect and Geri Assess Software. It explains the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria or specific study results that prove the device meets those criteria, especially in relation to AI/software performance in aiding embryo selection.

The document states:

• "Software verification and validation testing was conducted on the subject device in accordance with the FDA guidance document, 'Guidance for the Content of Premarket Submissions for Software in Medical Devices' issued on May 11, 2005."
• "The Geri Assess itself does not include any pre-loaded scoring assessments or perform any diagnostic functions."
• "Geri Assess includes a user annotation function for capturing information on embryo development parameters and a user-defined modelling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection."
• "The features added by this additional software do not represent a new intended use, and are seen in other cleared devices of this type."
• "The differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness."

Based on these statements, it appears the Geri Assess software provides tools for users to define and apply their own models for embryo selection, rather than itself being an AI that performs diagnostic functions or makes automated predictions based on pre-loaded algorithms. The regulatory submission likely focused on verifying the software's functionality, usability, and safety as a tool, rather than validating its performance in an AI-assisted diagnostic capacity.

Therefore, it is not possible to extract the requested information (acceptance criteria, specific study results, sample sizes, expert details, MRMC studies, AI effect size, etc.) from the provided text because these elements are not present. The document concludes that the device is substantially equivalent based on the software's functionality as a user-defined tool, rather than as a diagnostic AI requiring extensive clinical performance studies as described in the prompt.

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The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.

The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.

The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders. Each chamber can also contain an optional water bottle (Geri Water Bottle) to generate humidity. The Geri Water Bottle is supplied sterile with a sterility assurance level (SAL) of 10°, and has a shelf-life of three years. The Geri Water Bottle is designed to be used with the Geri Embryo Incubator only.

The embryos are maintained in Geri Dishes that are supplied separately. The Geri Dish is an optically-clear polystyrene dish designed to be compatible with the Geri Embryo Incubator. Up to 16 embryos can be stored in one Geri Dish. Geri Dishes are supplied sterile with a sterility assurance level (SAL) of 10°, and have a shelflife of 12 months.

The Geri Embryo Incubator and Geri Dish are intended to be used together for embryo imaging purposes. The Geri Dish is not compatible with other embryo time-lapse incubators. However, other assisted reproduction culture dishes may be used in the Geri Embryo Incubator in separate non-time-lapse positions located within each chamber.

The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.

This document, a 510(k) Summary for the Geri Embryo Incubator and Geri Dish, outlines the characteristics and testing for a medical device. It is not a document about an AI/ML-based medical device. Therefore, none of the specific questions regarding AI/ML device acceptance criteria, study design for AI/ML, sample sizes for AI/ML test and training sets, expert adjudication methods for AI/ML ground truth, or MRMC studies for AI assistance, can be answered from the provided text.

The document focuses on the substantial equivalence of the Geri Embryo Incubator and Geri Dish to a predicate device, with the main change being the addition of a humidity control system. The studies described are traditional non-clinical performance tests for an incubator and culture dish, such as electrical safety, EMC, cleaning validation, gas maintenance, temperature control, time-lapse imaging function, embryo development testing (mouse embryo assay), and sterilization validation.

Therefore, I cannot provide the requested information as the provided text relates to a medical device that does not appear to be an AI/ML device.

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The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.

The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.

The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders.

The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.

The embryos are maintained in Geri Dishes that are supplied separately. The Geri Dish is an optically-clear polystyrene dish designed to be compatible with the Geri Embryo Incubator. Up to 16 embryos can be stored in one Geri Dish. Geri Dishes are supplied sterile with a sterility assurance level (SAL) of 10-9, and have a shelf-life of 12 months.

The Geri Embryo Incubator and Geri Dish are intended to be used together for embryo imaging purposes. The Geri Dish is not compatible with other embryo time-lapse incubators. However, other assisted reproduction culture dishes may be used in the Geri Embryo Incubator in separate non-time-lapse positions located within each chamber.

The provided text is a 510(k) summary for the Geri Embryo Incubator and Geri Dish. It details the device, its intended use, comparison to predicate devices, and a summary of non-clinical performance testing. However, it does not include detailed acceptance criteria tables or specific reported device performance values for the Geri Embryo Incubator and Geri Dish.

Specifically, while it mentions "Bench performance tests that met design specifications described in Section VII" and lists some parameters like "Gas maintenance testing," "Temperature control testing," and "Time-lapse testing," it generally states that these tests "met design specifications" without providing the actual acceptance criteria values (e.g., specific CO2 levels, temperature ranges, or image resolution thresholds) and the precise device performance results.

Therefore, I cannot create a table of acceptance criteria and reported device performance from the provided text. The document describes the types of tests performed and generally states that the device met the specifications, but it does not quantify those specifications or the observed performance.

Similarly, the document provides limited information on most of the other requested criteria for a study proving the device meets acceptance criteria, as it is a 510(k) summary, not a detailed study report.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be created from the provided text. The document states that "Bench performance tests that met design specifications described in Section VII" and lists categories like "Gas maintenance testing," "Temperature control testing," and "Time-lapse testing." It also provides a specific acceptance criterion for the Geri Dish's Mouse Embryo Assay: "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours." However, the actual numerical design specifications (acceptance criteria) and the measured device performance for gas, temperature, and time-lapse functions are not provided.

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

• Sample size for test set: Not explicitly stated for most tests. For the mouse embryo assays, it implies a comparative group ("in comparison with the control group"), but the number of embryos or dishes tested is not given.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is typically lab-based bench testing.

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

• Not applicable / Not specified. This document describes performance testing for an incubator and dish, which are physical devices with measurable parameters (temperature, gas, imaging). The "ground truth" for these tests would be established through calibrated instruments and established scientific principles, not typically by expert consensus in the way, for example, medical image analysis AI models use expert radiologists. The "Embryo development test" and "Mouse embryo assay" are biological assays, where the "ground truth" is typically the observed biological outcome (blastocyst development), assessed by trained laboratory personnel, but no expert qualifications or numbers are mentioned.

4. Adjudication Method for the Test Set:

• Not applicable / Not specified. Adjudication is relevant for subjective assessments, particularly in clinical studies involving interpretation. The tests described are primarily objective benchtop and biological assays.

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

• No. An MRMC study is relevant for AI-assisted diagnostic devices where human readers interpret medical images. This document describes a medical device (incubator and dish) that does not directly involve human image interpretation in its primary function, nor does it describe AI assistance to human readers.

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

• Not applicable. This device is hardware with integrated software for control and imaging; it's not a standalone AI algorithm for interpretation. Its performance is inherent to the device's function.

7. Type of Ground Truth Used:

• For physical parameters (gas, temperature, imaging functions): Measured values against design specifications using calibrated instruments.
• For biological assays (mouse embryo development): Observed biological outcomes (e.g., blastocyst formation).

8. Sample Size for the Training Set:

• Not applicable. This is a hardware device with integrated control/imaging software, not a machine learning model that requires a "training set" in the conventional AI sense for learning patterns from data. The software mentioned ("Software verification and validation testing") refers to traditional software engineering V&V, not AI model training.

9. How Ground Truth for Training Set Was Established:

• Not applicable. (As explained above, no separate training set for an AI model is described.)

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Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.

The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes.

This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.

The provided text does not contain information about an AI device or a study comparing AI with human readers. It describes a submission for a medical device called "Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50," which is a reproductive medium used for oocyte retrieval.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI device or human-in-the-loop performance. The document focuses on demonstrating the substantial equivalence of the Oocyte Retrieval Buffer to a legally marketed predicate device through non-clinical performance testing.

However, I can extract the acceptance criteria and a summary of the non-clinical performance testing for the described Genea Biomedx Gems Oocyte Retrieval Buffer device.

Acceptance Criteria and Reported Device Performance (Table for the Oocyte Retrieval Buffer)

7. The sample size for the training set: Not applicable. This document pertains to a medical product, not an AI model requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.

Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.

The Gems Vitrification Set and Gems Warming Set are intended for the vitrification and warming of human blastocysts as part of human ART procedures.

The Gems Vitrification Set is designed to facilitate dehydration of blastocysts before vitrification via rapid cooling in liquid nitrogen. Dehydration of the blastocysts is achieved by the step-wise use of increasing concentrations of cryoprotectants in the Gems Vitrification Set, which results in water being withdrawn from the cell. The cryoprotectants also protect the blastocysts by reducing the potential for ice crystal formation during the vitrification process.

The Gems Vitrification Set consists of three solutions (Vitsol 2, and Vitsol 3). The base formulation for Vitsol 1 and Vitsol 2 is a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin. Vitsol 1 contains the cryoprotectant ethylene qlycol, while Vitsol 2 contains the cryoprotectants ethylene glycol and trehalose. Vitsol 3 consists of dimethyl sulphoxide (DMSO). The Gems Vitrification Set is not provided ready for use as Vitsol 3 must be added to the other vitrification solutions before use. Following DMSO addition to Vitsol 1 and 2, the final vitrification solutions for blastocyst vitrification procedures have the following properties:

• . Vitrification Solution 1 (Vitsol 1 + DMSO) - 8% ethylene glycol and 8% DMSO
• Vitrification Solution 2 (Vitsol 2 + DMSO) 16% ethylene glycol, 16% DMSO, and 0.57M trehalose ●

The Gems Warming Set consists of three warming solutions (Warmsol 2, and Warmsol 3), which are designed to facilitate the re-hydration (warming) of vitrified blastocysts. In the warming process, trehalose in the media manages the inflow of water into blastocysts as concentrations of DMSO and ethylene glycol are reduced during the rehydration process.

All three of the solutions in the Gems Warming Set consist of a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin, with varying amounts of the cryoprotectant trehalose as described below:

• . Warmsol 1 - 1.0 M trehalose
• Warmsol 2 0.5 M trehalose ●
• Warmsol 3 - No trehalose

These media are single-use devices that are aseptically filled into sterilized bottles and have a sterility assurance level (SAL) of 10 3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.

The provided document describes the acceptance criteria and performance testing for the "Gems Vitrification Set and Gems Warming Set" (subject device) in comparison to a predicate device, the "Cook Sydney IVF Blastocyst Vitrification Kit and Cook Sydney IVF Blastocyst Warming Kit" (K143724).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

8. The sample size for the training set

This information is not applicable. The device is not an AI algorithm that requires a training set. The descriptions relate to the manufacturing and quality control testing of physical chemical media.

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

This information is not applicable for the same reason as point 8.

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Gems Fertilisation Medium is used to provide a suitable environment for both oocytes and sperm and support in vitro fertilisation. This medium can be used for transfer of zygotes into the uterus.

Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8 cell stage. This medium can be used for transfer of cleavage stage embryos into the uterus.

Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage stage to the blastocyst stage of development. This medium can be used for transfer of blastocyst stage embryos into the uterus.

Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyst stage of development. This medium can be used for transfer of embryos into the uterus.

Gems VitBase is used to maintain embryos for a short period of time in a non-gassed environment during embryo vitrification and warming procedures. The embryos can be placed in this medium for a maximum of 10 minutes.

The subject devices are culture media consisting of salts, energy substrates, amino acids, buffering agents, nutrients supplements and antibiotics, with or without L-Carnitine and/or human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures in a hospital environment. These media are single-use devices that are aseptically filled into the sterilized bottles and have a sterility assurance level (SAL) of 10-3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.

This document describes the Genea Biomedx Genea Embryo Culture Media and its associated performance testing for substantial equivalence to predicate devices, as reviewed by the FDA.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for several key parameters are presented, primarily for shelf-life studies and comparison to predicate devices/literature.

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