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Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified occytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The five media products that comprise the two kits, Vit Kit - Freeze NX and Vit Kit -Warm NX, consist of a basal media of Continuous Single Culture Medium (CSCM) which utilizes MOPS, HEPES and sodium bicarbonate buffers, 20% (v/v) DSS, 10μg/mL gentamicin and varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), trehalose, and ethylene glycol (EG).

The two freeze media in the Vit Kit – Freeze NX are intended to be used sequentially for the preparation and cryopreservation of oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The three media in the Vit Kit - Warm NX are intended for sequential use in the thawing and recovery of cryopreserved oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

This document describes a 510(k) premarket notification for Vit Kit - Freeze NX and Vit Kit - Warm NX, which are reproductive media for vitrification (freezing) and thawing of oocytes and embryos.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the non-clinical performance data and the comparison to the predicate device. The document states that "The subject device passed the predefined acceptance criteria for these tests," confirming that the reported device performance met these criteria.

Note: The document only states "The subject device passed the predefined acceptance criteria for these tests" without providing specific numerical results for each test for the subject device. The table above uses the predicate's specifications or general qualitative criteria as a proxy for the acceptance criteria, which the subject device is stated to have met.

2. Sample Sized Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of vials tested for pH, number of embryos for MEA).
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be a lab-based non-clinical performance evaluation, not involving human subjects or patient data. It is a non-clinical performance data study, retrospectively conducted for the 510(k) submission.

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

This information is not applicable to this type of device and study. This 510(k) pertains to reproductive media, not an AI or imaging device requiring expert interpretation of results to establish ground truth. The "ground truth" for media performance is established through standardized laboratory assays (pH, osmolality, endotoxin, sterility, mouse embryo assay).

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective, laboratory-based measurements, not subjective human interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This 510(k) is for IVF media, which does not involve human reader interpretation in its intended use or performance evaluation.

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

No, a standalone algorithm performance study was not done. This concept is specific to AI/machine learning devices where the algorithm's performance is evaluated independently. This product is a biological medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations was established through objective laboratory measurements and standardized biological assays:

• Chemical assays (pH, Osmolality)
• Microbiological assays (Endotoxin, Sterility)
• Biological assays (Mouse Embryo Assay - MEA)

These are empirical measurements against predefined quality control specifications, rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that requires a "training set." The device is a manufactured chemical product.

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

This information is not applicable given that the device is not an AI/machine learning product and does not have a "training set."

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