(156 days)
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.)
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.