(36 days)
To provide an environment with controlled temperature, CO2 , (other gases), and elevated humidity for the development of ova or embryos at or near body temperature.
The devices are microprocessor controlled to regulate temperature, CO2 density, humidity level, alarms, and other parameters. The interior chamber consists of either stainless steel or a copper enriched stainless steel alloy, and housed within an insulated coated steel exterior cabinet. Operational accessories include options for an automatic CO2 cylinder switchover system, CO2 regulator, communication ports, and data acquisition software. Each device is a bench top or floor standing unit and direct line AC powered.
The provided text describes the Sanyo CO2 Incubators, Models Nos. MCO-17AC, MCO-17AIC, MCO-20AIC, and MCO-175M.
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Temperature Range | 5°C above ambient to +50°C with 0.1°C set-point increments | 5°C above ambient to +50°C with 0.1% set-point increments |
| Chamber Temperature Uniformity | 95%± 5% | |
| CO2 Range | 0 to 20% in 0.1% set-point increments | 0 to 20% in 0.1% set-point increments |
| O2 Level (if applicable) | 2-18% or 22-70% (using Zirconia solid-state electrolyte sensor technology) | Can be set to 2-18%, or 22-70% using Zirconia solid-state electrolyte sensor technology |
| EMC Safety | Conformance to relevant EMC safety standards | Performance and safety testing were performed to verify EMC safety |
| UV Strength (MCO-20AIC) | Conformance to specified UV strength | Performance and safety testing were performed to verify UV strength |
| Operating Specifications | Conformance to all stated operating specifications | Performance and safety testing were performed to verify operating specifications |
Note: The document explicitly states "Performance and safety testing were performed to verify operating specifications, EMC safety, and UV strength." For most parameters, the reported device performance matches the stated specification, implying that these were the acceptance criteria and they were met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). The testing described appears to be laboratory-based and developmental rather than clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a laboratory instrument, not a diagnostic imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This device is a laboratory instrument; adjudication methods are not relevant here.
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 is a CO2 incubator, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a CO2 incubator, not an algorithm-based device. The "standalone" performance here refers to the incubator's ability to maintain its specified environment independently, which is what the performance and safety testing aimed to verify.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device is the physical and environmental parameters it is designed to maintain (e.g., precise temperature, CO2 levels, humidity). This ground truth would have been established using calibrated laboratory measurement equipment that is independent of the incubator itself. For example, a calibrated thermometer for temperature, a calibrated CO2 sensor for CO2 levels, and a calibrated hygrometer for humidity.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI that would require a "training set." Its control system is based on PID algorithms and physical sensors, not a learned model.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for a machine learning model, there is no ground truth establishment for a training set. The control parameters are engineered and calibrated rather than learned.
§ 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.