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Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.

The Arctic™ Sperm Cryopreservation Medium is a modified version of the predicate device (K991337). It is a defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin. The Arctic™ Sperm Cryopreservation Medium is a single-use device that is aseptically filled into sterilized vials and has a sterility assurance level (SAL) of 10-3. This medium is supplied in a fill volume of 5 mL. and twelve (12) 5mL vials are included in a package, The product is tested for pH, osmolality, sperm cyrosurvival, endotoxin and sterility before lot release, and has a shelf-life of 18 months.

This document describes the Arctic™ Sperm Cryopreservation Medium, a device intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm. The regulatory submission (K171224) demonstrates its substantial equivalence to a predicate device (Sperm Maintenance Medium with Glycerol, K991337).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific number of samples for each test (e.g., pH, osmolality, endotoxin, sterility). For the Sperm Cryosurvival Assay, it states "Donor semen was mixed with the test medium and control (predicate device)". This suggests a comparative test using an unspecified number of donor semen samples. The data provenance is not specified regarding country of origin or whether it's retrospective or prospective; however, it is part of a regulatory submission for a medical device, implying prospective testing for the purpose of demonstrating substantial equivalence.

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

Not applicable. This device is a cryopreservation medium, and its performance is assessed through laboratory tests (e.g., pH, osmolality, microbiological growth, sperm motility), not through expert interpretation of images or clinical outcomes that require human ground-truthing in the typical sense of diagnostic AI.

4. Adjudication method for the test set

Not applicable. The tests are laboratory-based and yield objective measurements (e.g., pH values, osmolality values, presence/absence of growth, percentage motility) which do not require an adjudication method.

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 is not an AI-assisted diagnostic device for human readers.

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

The device itself is a standalone medical product (a cryopreservation medium). The performance tests described (e.g., pH, osmolality, sperm cryosurvival) are standalone evaluations of the product's physical, chemical, and biological properties, not an algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The 'ground truth' for this device's performance is established by objective, quantitative laboratory measurements and established scientific standards/methods (e.g., USP for sterility, USP for endotoxin, specified pH and osmolality ranges, and a minimum percentage of control motility for cryosurvival).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a "training set." The product is a chemical formulation.

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

Not applicable. As noted above, this device does not involve a training set.

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