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ORIGIO® Sperm Wash is intended for washing of spermatozoa, the isolation of motile viable sperm by swim-up method, dilution of ORIGIO gradients, and holding sperm for IUI procedure

ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 are for separation of motile sperm from the ejaculate by the density gradient method.

ORIGIO® Sperm Wash and ORIGIO® Gradient™ devices are for separation of motile sperm from semen and handling of sperm. These devices are based on the same formulation, but differ in the content of Human Serum Albumin (HSA), NaCl, bicarbonate, and silane silica. The silane silica generates the density, thus it is an ingredient in the ORIGIO® Gradient™ devices only and is not present in ORIGIO® Sperm Wash. All subject devices, except ORIGIO® Gradient™ 100, contain gentamicin and HSA.

The subject devices are aseptically filtered, colorless solutions. ORIGIO® Gradient™ devices are viscous while ORIGIO® Sperm Wash is non-viscous. They are contained in transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes, individually labeled and with instruction for use provided as a package insert.

The document provided describes the acceptance criteria and performance data for ORIGIO® Sperm Wash and ORIGIO® Gradient™ devices (100, 90, and 40/80). However, it does not describe a study involving an AI device or human readers with AI assistance. The document pertains to reproductive media and supplements, which are chemical solutions used in assisted reproductive technologies, not complex imaging or diagnostic AI systems.

Therefore, many of the requested points, such as AI-related metrics (human readers with/without AI assistance, standalone AI performance), expert qualifications, and adjudication methods, are not applicable to this submission.

Here's the information that can be extracted from the provided text, focused on the device's characteristics and its comparison to predicate devices:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The bench testing demonstrated that the subject devices met all product specifications," but it doesn't provide specific numerical results for each criterion to show how they met them, only the acceptance ranges.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Test set sample size: Not explicitly stated in terms of a "test set" as would be used for an AI algorithm. The performance evaluation was conducted on "sperm separated using subject devices" for "motility, morphology, viability, purity and integrity." The number of samples/donors used for this evaluation is not provided.
• Data provenance: Not specified. The document indicates the devices are manufactured by ORIGIO a/s in Denmark, but the location of the performance testing is not mentioned. The nature of the studies appears to be laboratory bench testing rather than clinical trials with patient data.

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

• Not applicable. This relates to the evaluation of a medical device (reproductive media), not an algorithmic diagnostic or imaging tool that requires human expert interpretation for ground truth establishment. The performance evaluation involved laboratory tests on sperm characteristics.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method described as it's not a study involving human interpretation of data for ground truth.

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 device or an imaging/diagnostic device that would involve human readers.

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

• Not applicable. This is not an AI device. The "standalone performance" refers to the device's ability to perform its function (sperm washing and separation) independently, which was evaluated through bench testing. The document states "The bench testing demonstrated that the subject devices met all product specifications." and "The sperm separated using subject devices were evaluated for motility, morphology, viability, purity and integrity in comparison with predicate and other cleared devices."

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

• The "ground truth" for the device's performance relies on laboratory measurements and established biological criteria for sperm characteristics (motility, morphology, viability, purity, integrity) as well as chemical and physical properties of the media (pH, osmolality, density, endotoxin levels, sterility, HSA concentration). There isn't a "ground truth" in the diagnostic sense (like a pathology report for an image).

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

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

• Not applicable. As above, no training set for an AI model.

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