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ORIGIO® Sequential Blast™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. ORIGIO® Sequential Blast™ can also be used for embryo transfer.

ORIGIO® Sequential Blast™ (with and without phenol red) is intended for the culture of human embryos from the 4-8 cell stage through to the blastocyst stage and for embryo transfer.

Two versions of ORIGIO® Sequential Blast™ are available:

• Catalogue no. 8305: ORIGIO® Sequential Blast™ .
• . Catalogue no. 8306: ORIGIO® Sequential Blast™ with phenol red

Both versions of ORIGIO® Sequential Blast™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.

The ORIGIO® Sequential Blast™ media are contained in 10 mL or 60 mL transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes of 1 x 10 mL and 1 x 60 mL bottles. The bottles and boxes are individually labeled. The boxes also contain instruction for use provided as package insert.

The provided document is a 510(k) summary for ORIGIO® Sequential Blast™ and ORIGIO® Sequential Blast™ with phenol red, a reproductive media for culturing human embryos. It focuses on demonstrating substantial equivalence to a predicate device, BlastAssist® (K080172), rather than presenting a study to prove acceptance criteria for a device involving AI or human-in-the-loop performance. Therefore, many of the requested elements are not applicable to this type of submission.

However, I can extract the relevant information regarding acceptance criteria and performance data for this specific medical device (embryo culture media):

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of product specifications between the proposed device (ORIGIO® Sequential Blast™) and the predicate device (BlastAssist®), which serve as the de-facto acceptance criteria for demonstrating substantial equivalence. The reported device performance is indicated by its ability to meet these comparable specifications.

2. Sample size used for the test set and the data provenance

The document describes "stability studies" and "Mouse Embryo Assay (MEA) test" as part of the performance data. However, it does not explicitly state the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is an embryo culture medium, not an AI or diagnostic device requiring expert interpretation of results for ground truth establishment.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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 information is not applicable as the device is not an AI or diagnostic device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" or validation is based on:

• Physicochemical properties: Meeting specified pH, osmolality, and endotoxin limits.
• Sterility: Absence of microbial growth.
• Biological performance: Mouse Embryo Assay (MEA) demonstrating proper embryonic development (≥80% 1-cell MEA).
• Stability studies: Showing the product maintains its specifications over its shelf life.

8. The sample size for the training set

This information is not applicable as the device is not an AI or machine learning system that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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