(52 days)
To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
The EmbryoScope™ - (Version D) is an embryo incubator, which performs a series of unattended measurements including time-lapse microscopy at multiple planes and logging of incubation conditions on individual embryos during their development. The device has a build-in microscope within a red light source. Separate processing units control the incubation environment and the data acquisition to ensure safe and reliable operation. The Device allows incubation of up to 72 individual embryos in six sterile disposable EmbryoSlides™ each with capacity for 12 embryos.
The provided document describes a 510(k) submission for a change in the indication for use of the EmbryoScope™ - (Version D) device. Therefore, the "acceptance criteria" discussed are related to demonstrating that the device remains safe and effective for the extended use duration, rather than performance metrics of an AI model.
Here's an analysis based on the information provided, framed to address the requested categories for a device rather than an AI:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implied by the need to demonstrate that extending the incubation period from 3 days to 5 days does not alter the safety and effectiveness of the device, specifically relating to ongoing pregnancies and adverse effects. The study aimed to show "non-inferiority" or "no significant difference" in relevant clinical outcomes.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Device remains safe (no adverse effects due to image acquisition or extended incubation) | "No adverse effects of image acquisition were observed." The device underwent and passed electrical safety, electromagnetic compatibility, environmental, and operating performance testing (as reported for both 3-day and 5-day use indications). |
| Device remains effective (e.g., similar ongoing pregnancy rates) for the extended 5-day incubation compared to 3-day incubation. | "No significant difference was found between the rates of ongoing pregnancies in the EmbryoScope™ - (Version D) with 5 days of incubation compared to three days of incubation." |
2. Sample size used for the test set and the data provenance
The document states: "Clinical data showed that the EmbryoScope™ - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in the EmbryoScope™ -- (Version D) with 5 days of incubation compared to three days of incubation. No adverse effects of image acquisition were observed."
- Sample Size: Not explicitly stated. The phrase "Clinical data" suggests a study was performed, but the number of embryos, patients, or cycles included in this "clinical data" is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics).
- Retrospective/Prospective: Not explicitly stated. However, "Clinical data showed..." implies an analysis of collected data, which could be either. The comparison to "three days of incubation" suggests either a prospective comparative trial or a retrospective analysis comparing cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the context of this device and submission. The "ground truth" here is objective clinical outcomes (ongoing pregnancies, observed adverse events), not a subjective assessment requiring expert consensus on image interpretation or similar tasks that an AI might perform.
4. Adjudication method for the test set
This section is not applicable. The "test set" here refers to clinical data for human fertility outcomes, not a set of items requiring human adjudication (like medical images).
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
This section is not applicable. The EmbryoScope™ is an IVF incubator with an imaging system; it is not an AI-powered diagnostic device for which human reader performance would be assessed with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is an incubator and imaging system, not a standalone algorithm. Its "performance" is its ability to maintain a suitable environment and acquire images effectively, ultimately supported by clinical outcomes.
7. The type of ground truth used
The ground truth used for assessing the device's effectiveness was clinical outcomes data, specifically:
- Rates of ongoing pregnancies.
- Observation of adverse effects potentially related to image acquisition or the extended incubation period.
8. The sample size for the training set
This section is not applicable. The device is not an AI model that requires a training set in the conventional sense. The "training" for the device would be its engineering, design, and manufacturing processes, supported by non-clinical testing (electrical safety, EMC, environmental, operating performance) rather than a data training set.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated above. The "ground truth" for the device's design and engineering is established through engineering principles, regulatory standards (e.g., IEC 60601-1), and extensive non-clinical testing to ensure hardware and software functionality, safety, and performance within specified environmental controls.
§ 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.