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Sperm Freeze is intended for the cryopreservation of human semen samples prior to use in assisted reproductive technology procedures.

Sperm Fridge is intended to protect human semen samples during refrigerated storage prior to use in assisted reproductive technology procedures.

Sperm Freeze and Sperm Fridge are preservation media intended for preserving sperm (short-term and long-term) for in vitro fertilization (IVF) and assisted reproduction technologies (ART). There are two methods for sperm preservation; freezing and refrigeration. Freezing is necessary for long-term sperm preservation, but may have disadvantages such as reduced survival rate and/or sperm motility after thawing. Refrigeration makes it possible to preserve sperm for several days without freezing and may be preferable for short-term preservation. Both products are intended to be used exclusively in a laboratory environment by trained professionals.

Sperm Freeze is a is a Tris-buffered solution containing the cryoprotectants glycerol and trehalose that is used for long-term sperm cryopreservation procedures. Sperm Fridge is a buffered solution (TES and Tris) that includes a nutrient source for sperm (dextrose) that is used for short-term sperm preservation procedures. Sperm Freeze and Sperm Fridge are offered in two volumes (0.5 mL and 10 mL, and 0.5 mL is sold in a pack of 5).

Here's a breakdown of the acceptance criteria and study information for the "Sperm Freeze, Sperm Fridge" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The "Reported Performance" column indicates that the device "passed" or "met criteria" based on the general statement in section 9: "Results confirm that the design inputs and performance specifications for the devices are met." Specific numerical results for each test (e.g., the exact percentage for sperm survival) are not provided in this summary.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Kitazato completed the following non-clinical tests" and refers to "internal requirements, national standards, and international standards."

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

This information is not provided in the document. The studies described are non-clinical (laboratory testing of the media itself), not clinical studies involving human samples and expert evaluation of outcomes in the way one might see for an AI diagnostic device.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests described are non-clinical and do not involve human interpretation or adjudication of results.

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:

This is not applicable. The device (Sperm Freeze, Sperm Fridge) is a reproductive media product, not an AI or imaging device that would involve human readers or AI assistance in interpretation. No MRMC study was conducted.

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

This is not applicable. The device is a chemical medium, not an algorithm or software. No standalone performance testing in this context was performed.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests appears to be laboratory measurements against established specifications and standards. For example, the pH measurement would be compared to the specified pH range (7.2-7.6), endotoxin levels compared to the maximum allowed (≤ 0.25 EU/mL), and sperm survival rates compared to the minimum required (≥ 80%). The "ground truth" is essentially the predefined acceptable range or threshold for each physical/chemical/biological property of the media.

8. The Sample Size for the Training Set:

This is not applicable. The device is a manufactured product, not a machine learning model that requires a training set.

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

This is not applicable for the same reasons as #8.

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