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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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ORIGIO® Sequential Fert™ is for the fertilization of oocytes in vitro.
ORIGIO® Sequential Cleav™ is for the culture of embryos until the 2-8 cell stage. ORIGIO® Sequential Cleav™ can also be used for embryo transfer at day 2 or 3.

ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ are aseptically filtered, non viscous solutions, light pink or colorless solutions, which are ready to use by professionals within assisted reproduction.
ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ 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.

This document describes the ORIGIO® Sequential Fert™ and ORIGIO® Sequential Cleav™ medical devices. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria from a standalone clinical study.

Therefore, a table of "acceptance criteria" and "reported device performance" specifically for the device's diagnostic performance (like sensitivity/specificity) is not provided in the typical sense of a diagnostic medical device. Instead, the "acceptance criteria" are implied by the comparison to predicate devices' specifications and functional properties through various laboratory tests.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally expressed as ranges or thresholds for various physicochemical properties and biological performance in comparison to predicate devices and recognized ART media. The reported device performance is stated to meet these specifications.

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

The document does not describe a clinical "test set" in the context of diagnostic device performance (e.g., patient data for sensitivity/specificity). Instead, the "testing" refers primarily to:

• Physicochemical analyses: pH, osmolality, endotoxin, sterility performed on batches of the manufactured media. The sample size for these manufacturing release tests is not specified but would typically follow internal quality control procedures.
• Mouse Embryo Assay (MEA): This is a biological test performed on mouse embryos to assess the media's ability to support embryo development. The sample size for MEA is stated as achieving "≥80%," indicating a pass/fail criterion rather than a detailed study sample size. The provenance of these mouse embryos or the exact number tested is not detailed.
• Stability Studies: Conducted to determine shelf life, testing pH, osmolality, endotoxin, HSA concentration, MEA, and sterility over time. The sample size (number of batches, number of samples per batch/time point) for these studies is not specified.
• Biocompatibility Testing: Performed for ORIGIO® Sequential Cleav™. This involves standardized in vitro and in vivo tests (cytotoxicity, sensitization, irritation). The sample size for these specific tests is not provided, but generally involves a predetermined number of test samples.

All data described appears to be retrospective (part of product development and qualification) and is generated by ORIGIO a/s (Denmark) or contracted laboratories.

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

N/A. This product is an in vitro fertilization (IVF) medium, not a diagnostic device that requires expert ground truth for interpretation of discrete outputs. The "ground truth" for its performance is assessed through its physical and chemical properties and its ability to support embryo development (MEA), which are objective laboratory measurements, not subjective expert interpretations.

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

N/A. As this is not a diagnostic device or a study involving human interpretation, an adjudication method for a "test set" is not applicable.

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

N/A. No MRMC study was conducted. This device is an IVF medium, not an AI or imaging device involving human readers.

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

N/A. There is no algorithm or AI component to this device.

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

The "ground truth" for this product's performance is established by:

• Physicochemical standards: pH, osmolality, endotoxin levels are measured against predefined acceptable ranges.
• Biological performance standards: The Mouse Embryo Assay (MEA) serves as a biological ground truth, where successful development of mouse embryos (≥80% 1-cell MEA) indicates the medium's suitability.
• Comparison to predicate devices: The "ground truth" for substantial equivalence is met by demonstrating that the new devices have comparable technological characteristics and performance to legally marketed predicate devices.

8. The sample size for the training set

N/A. This is not a machine learning or AI device, so there is no training set in that context. The "training" in product development refers to formulation optimization and initial testing, but no specific "training set" of data is mentioned.

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

N/A. See above.

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