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Medium for culture of embryos from fertilization to blastocyst stage

G-TL™ is an aseptically filtered and manufactured bicarbonate-buffered physiological medium ready to use after warming to 37°C and equilibration in a CO2 environment. It is designed to be used by professionals within assisted reproduction. G-TL™ is intended for the culture of human embryos from fertilization to the time of embryo transfer. G-TL™ is contained within a 30ml transparent polyethyleneterephthalate glycol (PETG) bottle with high density polyethylene (HDPE) closures. Both the bottle and box are individually labeled and each box contains a package insert.

The G-TL™ device is a medium for the culture of human embryos. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria for device performance in human subjects.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document mentions a "one-cell mouse embryo assay (MEA)" as the test method. However, it does not specify the sample size (i.e., the number of mouse embryos or experiments) used in this assay.
• Data Provenance: The study was an "animal study during product development." It can be inferred that the data is prospective as it was conducted to validate the new device. The country of origin for the data is not explicitly stated, but the submitting company is Vitrolife, Inc. based in Englewood, CO, USA.

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

• Ground truth in this context typically refers to the confirmed outcome against which the device's performance is measured.
• For the technical specifications (pH, osmolality, SAL, endotoxin), the "ground truth" is established by standard laboratory measurement techniques, not human experts.
• For the Mouse Embryo Assay (MEA), the assessment of "expanded blastocyst on Day 5" would involve expert observation and scoring, likely by trained embryologists or laboratory technicians. However, the document does not specify the number or qualifications of experts involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• Given that the MEA involves standardized biological endpoints (percentage of expanded blastocysts), it's unlikely that a formal adjudication method like "2+1" or "3+1" (common in image-based diagnostic studies) would be used.
• The results are likely based on objective counts and percentages validated by direct observation. The document does not describe any specific adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is not relevant for an IVF culture medium. The study performed compared the device to a predicate device using a mouse embryo assay.

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

• The G-TL™ is an IVF culture medium, not an algorithm or an AI device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. Its performance is evaluated through its biological effect on embryos.

7. The Type of Ground Truth Used

• For the technical specifications (pH, osmolality, etc.), the ground truth is based on standard analytical measurements (e.g., pH meters, osmometers, bacterial culture for SAL, LAL assay for endotoxin).
• For the mouse embryo assay, the ground truth is based on biological outcomes (percentage of expanded blastocysts) observed in a controlled in-vitro environment, which in itself serves as an indicator of embryo viability and developmental competence.

8. The Sample Size for the Training Set

• The document does not mention a training set. This is expected as the G-TL™ is a physical culture medium, not an AI model that requires training data. The "animal studies during product development" mentioned could be considered development/optimization studies, but not a "training set" in the machine learning sense.

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

• As there is no training set in the context of an AI device, this question is not applicable to the G-TL™ culture medium.

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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.

Note: The document does not provide specific numerical "reported device performance" results for pH, osmolality, endotoxin, or sterility, but states that these parameters were tested and met specifications or were comparable to predicate devices. For MEA, the specific percentage is given as >=80% in the table, implying this was maintained.

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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