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FertiCult™ Flushing medium are intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult™ Flushing medium can also be used human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity. The medium is NOT intended for oocyte pick-up and follicle flushing. FertiCult Flushing medium is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.

FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult Flushing media can also be used for human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity.

The base formulation contains Water, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Sulphate Heptahydrate, Sodium Dihydrogen Phosphate Dihydrate, Sodium Pyruvate, Glucose Monohydrate, Sodium Lactate, Sodium hydrogen carbonate, HEPES, Human Serum Albumin.

A FertiCult Flushing media variant contains Phenol red and Gentamicin.

The products can be used up to 7 days after opening, when sterile conditions are maintained, and the products are stored at 2-8°C.

The provided FDA 510(k) clearance letter pertains to the FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin. This document demonstrates the substantial equivalence of the new device to a predicate device, as required for FDA clearance.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed are primarily for the physical, chemical, and biological properties of the media, ensuring its quality and suitability for use in Assisted Reproductive Technology (ART) procedures.

Note: The document states that the product specifications were "met at time 0 and after real-time aging" for shelf-life, and "met seven days after opening" for in-use testing.

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

The document does not explicitly state the specific sample sizes used for each test (e.g., how many batches were tested for pH, how many mouse embryos for MEA). It indicates that the tests were conducted for "validation and routine control" and to "support a shelf-life of 18 months" and "stability after bottle opening."

Regarding data provenance:

• The studies are non-clinical performance tests conducted in support of substantial equivalence.
• The data would originate from laboratory testing of the manufactured FertiCult media.
• The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's for a new product obtaining FDA clearance, it would be prospective testing of the device for submission.

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

These types of tests (chemical assays, sterility, endotoxin, MEA, biocompatibility) do not typically involve human experts to establish "ground truth" in the way clinical studies often do. The "ground truth" is established by adherence to recognized scientific and regulatory standards (e.g., USP monographs, ISO standards, FDA guidance documents) by trained laboratory personnel. The document does not specify the number or qualifications of individuals performing these specific tests, but it can be assumed they are qualified laboratory technicians or scientists.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies with human interpretation (e.g., imaging reads). For the non-clinical laboratory tests described here, adjudication is not applicable. The results are quantitative measurements or qualitative observations (e.g., presence/absence of microbial growth, precipitates) interpreted against defined numerical or descriptive criteria set by the relevant standards.

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

No. The provided document is for the premarket notification (510(k)) of a reproductive media product. MRMC studies are typically performed for diagnostic imaging devices or other devices where human interpretation is a key component and the AI system's impact on human performance is being evaluated. This document focuses on the safety and effectiveness of the media itself through laboratory and biocompatibility testing, not on human-AI interaction.

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

No. This device is a culture medium, not an algorithm or AI-powered system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:

• Established scientific and regulatory standards: USP monographs (<791> for pH, <785> for Osmolality, <71> for Sterility, <85> for Bacterial Endotoxin), ISO standards (e.g., ISO 13408, ISO 11137, ISO 17665, ISO 10993 series), ASTM D4169-22.
• Historically accepted biological performance indicators: Mouse Embryo Assay (MEA) results (development to expanded blastocyst), as specified by the 2021 FDA guidance.
• Observed physical and chemical characteristics: Absence of precipitates.

These are objective, quantifiable, or universally accepted biological endpoints, rather than expert consensus on a subjective interpretation.

8. The Sample Size for the Training Set

Not applicable. This device is a culture medium, not an AI/ML algorithm that requires a training set. The performance testing described validates the manufacturing quality and biological compatibility of the product.

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

Not applicable, as this is not an AI/ML device requiring a training set.

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