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Sperm Maintenance Medium with Glycerol is intended for the cryopreservation of human sperm prior to assisted reproductive procedures.
Sperm Maintenance Medium with Glycerol is intended for use in assisted reproductive procedures that involve the manipulation of gametes. Specifically, Sperm Maintenance Medium with Glycerol is intended to be used as a cryopreservation medium for human sperm.

Sperm Maintenance Medium with Glycerol is a synthetic, defined medium composed of a mixture of salts and other physiologically compatible substances, with glycerol as a cryoprotectant and human serum albumin as a protein supplement. It is supplied in fill volumes of 100 mL.

The provided text describes a 510(k) submission for "Sperm Maintenance Medium with Glycerol." The document focuses on regulatory approval rather than a detailed device performance study with specific acceptance criteria and outcome metrics in the conventional sense of AI/Software as a Medical Device (SaMD).

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of submission, as it concerns a physical reproductive medium rather than a software algorithm or AI model.

Here's the information that can be extracted and a clear indication of what is not present in the provided text:

1. Table of acceptance criteria and the reported device performance:

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

• Not applicable / Not provided. The document describes a "sperm cryopreservation and motility recovery assay" that will be performed prior to release, but it does not specify the sample size of sperm donors or samples used in this assay, nor the provenance (country of origin, retrospective/prospective). It mentions the product has been used in a "variety of clinical settings" for "a number of years," implying historical usage data but without specific study details.

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

• Not applicable / Not provided. This is not relevant for a physical medium. Ground truth in this context would likely be defined by laboratory assay results and clinical outcomes, not expert consensus on image interpretation or diagnosis.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert opinions for ground truth establishment in studies involving human interpretation. This is not applicable to the assay of a physical medium.

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:

• Not applicable. This document pertains to a physical cryopreservation medium, not an AI or software device that would interact with human readers.

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

• Not applicable. This is not a software algorithm.

7. The type of ground truth used:

• For the performance assessment of the medium (sperm cryopreservation and motility recovery assay): The "ground truth" is defined by laboratory assay results (e.g., sperm viability, motility post-thaw, absence of toxicity markers) which are quantitative and objective measurements.
• For the general suitability and meeting regulatory criteria: This includes a review of historical information (professional literature) and a history of satisfactory use in clinical settings. This implies real-world outcomes data and established scientific understanding.

8. The sample size for the training set:

• Not applicable. This product is not an AI/ML model that requires a training set.

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

• Not applicable. See point 8.

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