(63 days)
The COOK Test Tube Heater is intended to be used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. The unit is designed to accept up to six Falcon® 2001 Series 10 mL test tubes.
The COOK Test Tube Heater is an electronically controlled heating unit that holds collection test tubes and their contents during oocyte recovery. The unit is designed to accept up to six Falcon® 2001 Series 10 mL test tubes.
Due to the nature of the device being a test tube heater and the provided documents focusing on its regulatory approval rather than clinical studies, much of the requested information (especially points 2, 3, 4, 5, 6, 7, 8, and 9 related to human subject studies or complex AI algorithms) is not applicable. The documentation primarily describes substantial equivalence to a predicate device and basic performance testing.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain the temperature of egg (oocyte) collection tubes at or near body temperature. | "The COOK Test Tube Heater was subjected to testing to assure satisfactory operating performance. The COOK Test Tube Heater passed the requirements of all tests." (Specific temperature ranges or tolerances are not provided in the submitted documents.) |
2. Sample size used for the test set and the data provenance
Not applicable. The provided document describes technical performance testing of a device (a test tube heater), not a study involving human subjects, images, or biological samples with associated data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of expert review, is not relevant for a test tube heater's performance evaluation as described. Performance is measured against engineering specifications.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., image analysis by multiple readers) to resolve discrepancies. This is not relevant for a device like a test tube heater.
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 device is not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware component; it does not involve algorithms or AI.
7. The type of ground truth used
For the performance of the test tube heater, the "ground truth" would be established engineering specifications and measurement standards (e.g., calibrated thermometers). The document states the device "passed the requirements of all tests," indicating it met these pre-defined technical specifications.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI algorithms that require a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.