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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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