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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).

Conclusion: The KIDScore D3 device’s reported performance (OR of 4.13 with a p-value <0.0001) significantly exceeds the acceptance criterion, demonstrating its ability to predict blastocyst outcome when used as an adjunct to morphology.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 81 patients, including their embryos (number of embryos not explicitly stated for the test set, but mentioned as "embryos from 81 patients").
• Data Provenance: Retrospective. The data was a subset taken from a total collection of 4152 embryos from 1338 treatments carried out in European IVF clinics between 2009 and 2014.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used to establish the ground truth for the test set nor their specific qualifications (e.g., years of experience). It mentions:

• "Embryologists were masked to imaging data and evaluation was only based on morphology and KIDScore D3 scores." This implies embryologists were involved in the morphological grading, which is part of the overall assessment.
• The "adjunct prediction of blastocyst outcome and the actual blastocyst outcome" were assessed. This "actual blastocyst outcome" serves as the ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1) for resolving discrepancies in ground truth establishment for the test set. It states that "Embryologists were masked to imaging data and evaluation was only based on morphology and KIDScore D3 scores," which suggests individual assessments were made.

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, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers' improvement with and without AI assistance was not explicitly conducted or reported. The study focused on the device's ability to predict blastocyst outcome as an adjunct to morphology, and its performance was compared to the predicate device, not necessarily against human readers in an assisted vs. unassisted paradigm for their performance improvement. The study evaluated "the utilization of established morphology methods with adjunct outcome of an algorithm (KIDScore D3)" and concluded that "the adjunct use of KIDScore D3 improved the selection of embryos for transfer compared with morphology alone." However, it does not quantify the effect size of how much human readers themselves improved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance of the algorithm was implicitly evaluated. The primary endpoint, "the association between the adjunct prediction of blastocyst outcome and the actual blastocyst outcome," assesses the KIDScore D3's predictive capability in conjunction with morphology. While it's adjunctive information, the study's results (Odds Ratio for KIDScore D3) clearly reflect the algorithm's standalone predictive power within the context of the study design. It was evaluated for its ability to predict which embryos are most likely to develop to blastocyst stage. The phrase "Embryologists were masked to imaging data and evaluation was only based on morphology and KIDScore D3 scores" means the KIDScore D3 scores were provided directly to the embryologists as part of their evaluation, indicating the algorithm's output was central to the assessment.

7. The Type of Ground Truth Used

The ground truth used was actual blastocyst outcome (i.e., whether an embryo developed to the blastocyst stage). This can be considered a form of outcome data directly observed during the IVF process.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It mentions the "data included embryos from 81 patients" for the clinical study (test set), and that this "data are a subset taken from a total collection of 4152 embryos from 1338 treatments where all sibling embryos have been annotated for the morphokinetic events required by KIDScore D3." This larger collection of 4152 embryos is likely the source from which the algorithm was developed and presumably trained, but the exact training set size is not segregated.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set (if it was a separate, formally defined set) was established. However, given the nature of the device, it's highly probable that similar to the test set, the ground truth for the training data (from the "total collection of 4152 embryos") would have been established by observing whether the embryos developed to the blastocyst stage, potentially combined with expert morphological assessment done during the standard clinical practice at the time the data was collected (2009-2014). The manual annotation of parameters like pronuclei, tPNf, t2, t3, t4, t5, and t8 would have been linked to these observed blastocyst outcomes to develop the KIDScore D3 model.

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