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The product is intended for in vitro culture of human embryos following fertilization until Day 5/6 of development. The media can also be used for embryo transfer.

SAGE 1-Step™ GM-CSF with HSA and SAGE 1-Step™ GM-CSF with SPS are assisted reproduction embryo culture media products consisting agents, physiological salts, energy substrates, amino acids, antibiotics, protein supplements (HSA or SPS), and granulocyte-macrophage colony-stimulating factor (GM-CSF, 2 ng/ml). These devices are aseptically filtered (sterility assurance level of 10 %), and supplied in 3 ml glass vials. They are tested for pH, osmolality, embryotoxicity, endotoxin, sterility, and GM-CSF concentration and potency before lot release. These devices have a shelf-life of 16 weeks, and can be used for up to seven days after vial opening when stored at 2-8°C.

Here's an analysis of the acceptance criteria and study information based on the provided text, focused on the SAGE 1-Step™ GM-CSF with HSA and SAGE 1-Step™ GM-CSF with SPS devices:

This document is a 510(k) summary for a medical device that appears to be an embryo culture media, not an AI/ML powered device, therefore some of the requested information (like multi-reader multi-case studies, AI impact, human-in-the-loop, training set sizes, and expert qualifications for ground truth in the context of diagnostic performance) are not applicable. The evaluations are primarily focused on the chemical, physical, and biological properties of the media itself.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size used for the test set and the data provenance:

   • Sample Size: The document does not specify a numerical sample size for individual tests like pH, osmolality, endotoxin, sterility, or GM-CSF concentration/potency beyond "real-time" shelf-life testing. For the Mouse Embryo Assay (MEA), it states "One-cell mouse embryos were exposed...", but the exact number of embryos or replicates is not provided.
   • Data Provenance: The studies were performed as part of the regulatory submission by ORIGIO a/s (Denmark). The data is generated from non-clinical laboratory testing (in vitro), not human patient data. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission on the manufactured media.

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

   • This question is not applicable as the device is not an AI/ML diagnostic or image analysis tool. Ground truth in this context refers to established laboratory standards and measurement techniques (e.g., pH meters, osmometers, ELISA, cell assays, microscopic assessment of embryo development against a standard). The "ground truth" is determined by the output of these standardized assays, not by expert consensus on complex diagnostic cases.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This is not applicable for this type of device and study. Adjudication methods like 2+1 are typically used for reconciling disagreements among human readers/annotators in diagnostic studies. The results here are based on objective laboratory measurements.

4. 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 MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This device is an embryo culture media, not a diagnostic tool requiring human reader interpretation in its intended use.

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

   • This is not applicable. There is no algorithm or AI component in this medical product. The performance is the inherent biological and chemical properties of the media itself.

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

   • The "ground truth" for the performance specifications relies on established laboratory methodologies and reference standards:
     • Standardized Analytical Measurements: pH meters, osmometers, spectrophotometers (for ELISA), LAL assays for endotoxin.
     • Biological Assays: Mouse Embryo Assay (MEA) results (percentage of embryos reaching blastocyst stage), TF-1 cell assay for GM-CSF potency. These assays have predefined criteria for success and are considered objective measures of the media's biological suitability.
     • Sterility Testing: USP standards for microbial growth.

7. The sample size for the training set:

   • This is not applicable as this device is not an AI/ML product. There is no "training set" in the context of machine learning. The media's formulation is developed based on scientific understanding of embryo biology.

8. How the ground truth for the training set was established:

   • This is not applicable as there is no training set for an AI/ML algorithm. The "ground truth" for the media's development and validation would stem from scientific literature on embryo development, established laboratory protocols, and regulatory standards for reproductive media.

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