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"Medi-Cult Sperm Freeze Medium" is intended for the cryopreservation of human spermatozoa and tissue from testicular biopsies.

"Medi-Cult Sperm Freeze Medium" is composed from a modified Tyrodes Solution that has been Hepes buffered. The cryoprotective is Glycerol (15% v/v) and its cryoprotective properties have been enhanced by the addition of Assisted Reproduction Technique Supplement (ARTS) and human serum albumin.

The provided text describes the "Medi-Cult Sperm Freeze Medium" and its performance compared to a predicate device, TEST-Yolk buffer (TYB). Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a formal table with pass/fail values. Instead, it aims to demonstrate that its performance is not significantly different or is superior to the predicate device, TEST-Yolk buffer (TYB).

Note: The acceptance criteria are implicitly that the device performs at least as well as, or better than, the predicate device in relevant sperm viability and functional assays.

2. Sample Sizes used for the Test Set and Data Provenance:

The document provides summary statistics (means and standard errors), but the exact sample sizes (number of patients or sperm samples) used in either study are not explicitly stated.

• Data Provenance:
  • Sperm Survival Study: Rochester Regional Cryobank and Andrology Laboratory, University of Rochester Medical Center, Rochester, NY, USA. (Prospective, comparing the two media on fresh semen samples).
  • Hemi-Zona Assay: The Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, USA. (Prospective, comparing the ability of sperm frozen in the two media to bind to isolated zona pellucidae).

3. Number of Experts used to establish the Ground Truth for the Test Set and their Qualifications:

• Sperm Survival Study: The study was conducted at a "Cryobank and Andrology Laboratory." The assessment of motility, viability, and normal cells would typically involve trained technicians or scientists using established methodologies (e.g., CASA for motility, manual counts for viability/morphology). The document does not specify the number or qualifications of these "experts," but it implies standard laboratory practice.
• Hemi-Zona Assay: Dr. Mary Mahoney at The Jones Institute for Reproductive Medicine. Dr. Mahoney is identified as the evaluator, implying an expert in reproductive medicine or embryology. Her specific qualifications (e.g., number of years of experience, specific certifications) are not detailed.

4. Adjudication Method for the Test Set:

Not applicable. This is a scientific study comparing two products, not a diagnostic device where adjudication of interpretations against a ground truth is typically required. The results are quantitative measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done and its effect size:

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and an AI system might assist them. The product here is a cryopreservation medium, and the studies involve direct measurement of sperm parameters and function, not reader interpretation.

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

Not applicable. The product is a cryopreservation medium, not an algorithm or AI device. The studies directly measure the biological impact of the medium on sperm.

7. The Type of Ground Truth Used:

• Sperm Survival Study: The "ground truth" is the measured biological parameters of sperm (motility, viability, morphology, velocity) determined using established laboratory methods. This is equivalent to laboratory assay results. The fresh semen served as a baseline control, and the comparison was between the two freezing media.
• Hemi-Zona Assay: The "ground truth" is the measured ability of sperm to bind to isolated zona pellucidae, which is a functional assessment critical for fertilization. This is also laboratory assay results or functional outcome data in a controlled invitro setting.

8. The Sample Size for the Training Set:

Not applicable. This is a cryopreservation medium, not a machine learning algorithm that requires a "training set." The product's formulation is based on "data published in peer reviewed international journals by internationally recognised scientists in the field," which acts as a form of scientific basis or "prior knowledge" rather than a computational training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" in the context of an AI/ML device. The ground truth for the scientific basis of the formulation would be derived from decades of reproductive biology research and established scientific methodologies for assessing media components and sperm cryopreservation success.

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