(290 days)
The KIDScore D3 tool provides decision support for prediction of embryos developing to the blastocyst stage by scoring them according to their statistical viability.
Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
The KIDScore D3 tool is only to be used with the EmbryoScope timelapse incubator systems.
The KIDScore D3 decision support tool is an adjunctive algorithm that is designed to support embryologists in their decision about which embryos are suitable for transfer. The tool is an optional accessory to the EmbryoViewer software. It is used in the "Compare & Select" function. The "D3" in the name refers to the use of the algorithm on Day 3 for aiding the embryologist in preparing for transfer of the embryo to the female patient.
KIDScore D3 utilizes the following manually annotated parameters to aid in identifying embryos that are suitable for transfer:
- Pronuclei (number of pronuclei): ●
- tPNf (time from insemination until pronuclei is fading) ●
- t2 (time from insemination to complete division to two cells) ●
- t3 (time from insemination to complete division to three cells) ●
- t4 (time for insemination to complete division to four cells) .
- t5 (time from insemination to complete division to five cells) ●
- t8 (time from insemination to complete division to eight cells) ●
The KIDScore D3 assigns scores by comparing the parameters above in embryos to the model criteria, one criterion at a time until the process stops either because the embryo did not pass one of the criteria in the sequence or because the last criterion in the model was reached. From the information available at day three of incubation, the KIDScore D3 divides embryos into five score groups (1-5, as described below):
- 0 = The embryo is not 2PN
- 1 = Initial development was too fast or the embryo displayed a direct cleavage from one to three cells
- 2 = The embryo was slow to develop
- 3 = Embryo development was irregular and the development pace increased from day two to day three
- 4 = Embryo development was irregular and the development pace slowed from day two to day three
and/or
The number of cells annotated at 66 hours was not as expected
5 = The embryo passed all of the avoidance criteria included in the model.
One or more computers running the EmbryoViewer software may be connected to the ES Server. KIDScore D3 is stored on the computer running the ES Server software. Calculations related to the model in KIDScore D3 are performed on the computer running the ES Server software.
This document describes the KIDScore D3 device, an adjunctive algorithm designed to support embryologists in selecting suitable embryos for transfer by predicting their likelihood of developing to the blastocyst stage.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the primary endpoint of the clinical study, which required the blastocyst Odds Ratio (OR) for the adjunct prediction to be statistically significantly greater than 1 for Good/Fair embryos (graded A, B, or C using Day 3 morphology).
| Acceptance Criteria | Reported Device Performance (KIDScore D3) | Reported Device Performance (Eeva System - Predicate) |
|---|---|---|
| Blastocyst Odds Ratio (OR) for adjunct prediction (for Good/Fair embryos) statistically significantly greater than 1 | 4.13 | 2.57 |
| 95% Confidence Interval for OR | 3.48 - 4.9 | 1.88 - 3.51 |
| P-value for OR | ** |
§ 884.6195 Assisted Reproduction Embryo Image Assessment System.
(a)
Identification. An Assisted Reproduction Embryo Image Assessment System is a prescription device that is designed to obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing.(b)
Classification. Class II (special controls). The special control(s) for this device are:(1) Clinical performance testing must demonstrate a reasonable assurance of safety and effectiveness of the device to predict embryo development. Classification performance (sensitivity and specificity) and predictive accuracy (Positive Predictive Value and Negative Predictive Value) must be assessed at the subject and embryo levels.
(2) Software validation, verification, and hazard analysis must be provided.
(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Total light exposure and output testing;
(ii) A safety analysis must be performed based on maximum (worst-case) light exposure to embryos, which also includes the safety of the light wavelength(s) emitted by the device;
(iii) Simulated-use testing;
(iv) Mouse Embryo Assay testing to assess whether device operation impacts growth and development of mouse embryos to the blastocyst stage;
(v) Cleaning and disinfection validation of reusable components;
(vi) Package integrity and transit testing;
(vii) Hardware fail-safe validation;
(viii) Electrical equipment safety and electromagnetic compatibility testing; and
(ix) Prediction algorithm reproducibility.
(4) Labeling must include the following:
(i) A detailed summary of clinical performance testing, including any adverse events;
(ii) Specific instructions, warnings, precautions, and training needed for safe use of the device
(iii) Appropriate electromagnetic compatibility information;
(iv) Validated methods and instructions for cleaning and disinfection of reusable components; and
(v) Information identifying compatible cultureware and explain how they are used with the device.