(212 days)
EmbryoScope+ consists of the following devices with the following indications for use:
The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.
The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.
The Embryo Viewer software is intended for displaying, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo Viewer software does not control any hardware components in the EmbryoScope+ incubator.
The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.
The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software must be used together to analyze the embryo images.
EmbryoScope+ consists of the following devices: EmbryoScope+ incubator, EmbryoSlide+ culture dish, EmbryoViewer software, and ES Server software.
The EmbryoScope+ incubator is a bench top embryo incubator with a time-lapse imaging function. It provides temperature control, and time-lapse microscopy at multiple focal planes. This device can hold up to 15 culture dishes (EmbryoSlide+ culture dish) in the incubation chamber. The culture dishes are placed on the dish holder in the EmbryoScope+ incubator. The holder provides direct heat transfer to the EmbryoSlide+ culture dish. The built-in microscope consists of an LED illumination unit and an inverted microscope/camera unit. During image acquisition, each culture dish located on the culture dish holder is rotated to the microscopy system and individual image stacks are acquired from all individual embryos in each culture dish.
The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10° and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.
The EmbryoViewer software is used for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. The data that can be viewed using this software includes embryo images, incubation details, alarms, log files and other instrument parameters. This software also includes a user annotation for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics.
The ES Server software allows users to update and view common data. The server acts as the central unit, which stores data and controls the data flow to and from the connected devices. The server can be connected to multiple EmbryoScope+ incubators and computers with the EmbryoViewer software installed.
The provided text does not contain information about a "study that proves the device meets the acceptance criteria" in the format of a clinical trial or a specific comparative effectiveness study with human readers and AI assistance. Instead, it describes non-clinical performance testing conducted to support the substantial equivalence of the EmbryoScope+ device to its predicate devices.
The acceptance criteria are generally implied by the design specifications and testing standards mentioned.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
The text doesn't explicitly present a direct "acceptance criteria" vs. "reported performance" table for all aspects. However, it lists performance specifications for the EmbryoScope+ incubator and the results of various non-clinical tests.
| Characteristic / Test | Acceptance Criteria (Implied by design specification/standard) | Reported Device Performance |
|---|---|---|
| EmbryoScope+ Incubator | ||
| Culture dish capacity | N/A (Comparison to predicate) | 15 dishes |
| Temperature range | N/A (Comparison to predicate) | 36-39°C |
| Temperature accuracy | N/A (Comparison to predicate) | +/- 0.2°C |
| CO₂ accuracy | N/A (Comparison to predicate) | +/- 0.3 % |
| O₂ accuracy | N/A (Comparison to predicate) | +/- 0.5 % |
| Recirculation rate | N/A (Comparison to predicate) | >100 L/h (full purification of gas volume every 6 min) |
| CO₂ recovery (5% ± 0.3 %) after 30s load door open | and ANSI/AAMI ST72:2002) | Met the specification of ≤20 EU/device |
| Mouse embryo assay (MEA) | ≥80% embryos developed to blastocyst in 96 hours (for 1-cell MEA) | "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours." |
| General Non-Clinical Testing | ||
| Electrical safety | Compliance with IEC 60601-1:2005 + C1:2006 + C2:2007 + A1:2012 | Testing conducted |
| Electromagnetic compatibility | Compliance with EN/IEC 60601-1-2:2007 | Testing conducted |
| Software V&V | Met FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) | Testing conducted |
| Radiation sterilization | Compliance with ISO 11137-2:2013 | Testing conducted |
| Transportation simulation | Met ASTM D4169-16 | Testing conducted |
| Package integrity (Bubble test) | Per ASTM F2096-11 | Testing conducted |
| Package integrity (Peel strength) | Per ASTM F88/F88M-09 | Testing conducted |
| Gas maintenance (levels, flow, recovery) | Met design specifications (described in Section 7) | Met design specifications |
| Temperature control | Within defined ranges and stable over time | Met design specifications |
| Time-lapse function (image acquisition, quality, resolution) | Met design specifications | Met design specifications |
| Light intensity | Lower than predicate device | Shown to be lower than the predicate device |
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 describes non-clinical bench testing. For the Mouse Embryo Assay (MEA), the sample size is implicitly "one-cell mouse embryos" without a specific number. The data provenance is not mentioned (e.g., country of origin). The testing seems to be experimental/prospective in nature, rather than retrospective use of human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes non-clinical performance and engineering testing (electrical safety, EMC, software V&V, bench performance, sterilization, package integrity, endotoxin, mouse embryo assay). These do not involve human experts establishing ground truth for a diagnostic AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is non-clinical performance testing, not a clinical study requiring adjudication of expert interpretations.
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
No MRMC comparative effectiveness study is mentioned. The device, EmbryoScope+, includes software (EmbryoViewer) with "user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection." However, the text details non-clinical testing for substantial equivalence, not a clinical study on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
While the EmbryoViewer software includes "user-defined modeling function" to "aid in embryo selection," the substantial equivalence argument relies on comparing the entire system (incubator, software, dish) to predicate devices through non-clinical performance metrics. There is no specific mention of a standalone algorithm performance study without human involvement, particularly relating to "embryo selection" capability. The software primarily displays, stores, transfers images, and allows for user annotation and user-defined modeling, implying human-in-the-loop use. It explicitly states, "The EmbryoViewer software neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- EmbryoSlide+ Culture Dish (MEA): The "ground truth" for the MEA test was defined by the biological outcome: "percent of embryos developed to the expanded blastocyst stage within 96 hours." This is an objective biological endpoint.
- Other non-clinical tests (electrical safety, EMC, metrology, etc.): Ground truth is established by adherence to engineering specifications, recognized standards (e.g., IEC, EN, ASTM, ISO, USP, ANSI/AAMI), and design specifications.
8. The sample size for the training set
Not applicable. The document does not describe a machine learning model that requires a training set in the conventional sense. The "user-defined modeling function" in the EmbryoViewer software suggests that users define their own criteria based on embryo development parameters, rather than the device itself being trained on a large dataset.
9. How the ground truth for the training set was established
Not applicable, as no machine learning training set 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.