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FreezeKit™ Cleave is intended for freezing of pronuclear (2PN) and cleavage-stage embryos.

ThawKit™ Cleave is intended for thawing of frozen pronuclear (2PN) and cleavage-stage embryos.

FreezeKit™ Cleave and ThawKit™ Cleave are devices used for freezing of pronuclear (2PN) and cleavage-stage embryos, and thawing of frozen pronuclear (2PN) and cleavage-stage embryos during in vitro fertilization (IVF) procedures.

The proposed devices are two separate kits, containing two and three solutions respectively. The two kits are marketed separately, yet are recommended to be used together to perform freezing and thawing. All solutions in both kits contain MOPS buffered solution, gentamicin as an antibacterial agent, human serum albumin and hyaluronan. The cryoprotectants 1,2 - propanediol and sucrose are included in the freezing solution, and only sucrose is included as a cryoprotectant in the thawing solutions.

The provided document is a 510(k) Premarket Notification for medical devices, specifically for "FreezeKit™ Cleave" and "ThawKit™ Cleave," which are reproductive media used for cryopreservation and thawing of embryos. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study with robust statistical analysis typically seen in PMAs or studies for AI/software as a medical device.

Therefore, the information required to fully answer the request (especially regarding AI/ML, human expert involvement, ground truth establishment, sample sizes for training/test sets, MRMC studies, and effect sizes) is not present in this document. The "clinical testing" described here is more akin to a performance evaluation rather than a comparative effectiveness study in the context of AI.

I will populate the table and answer the questions based only on the information available in the provided text. Where information is not available or not applicable, I will state "Not available in the provided text" or "Not applicable to this device/study type."

Acceptance Criteria and Device Performance Study

The study performed was a non-inferiority performance evaluation demonstrating that the subject devices (FreezeKit™ Cleave and ThawKit™ Cleave) perform comparably to predicate devices (Cook IVF Cryopreservation Kit and Cook IVF Thawing Kit) for their intended use. The core of this submission is to show substantial equivalence, not necessarily superior performance or to evaluate an AI algorithm.

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text for either non-clinical or clinical testing. For the clinical evaluation, it mentions "human 2PN embryos and cleavage-stage embryos," but no number.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics).
• Retrospective or Prospective: Not explicitly stated for the clinical evaluation. Given the context of a 510(k) premarket notification for a new version of existing media, it's likely a controlled prospective performance study, but this is an inference.

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

• Number of Experts: Not applicable, as this is a device for media used in IVF, not an AI or diagnostic imaging device requiring expert interpretation. The "ground truth" would be the biological outcome (survival, development) measured directly or observed by trained embryologists/laboratory personnel.
• Qualifications of Experts: Not explicitly stated, though it would be assumed that the studies were conducted by qualified laboratory personnel and embryologists.

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

• Adjudication Method: Not applicable. The "results" are biological outcomes measured/observed, not subjective interpretations requiring adjudication among multiple readers.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is not an AI or imaging device that would involve human readers or AI assistance in interpretation.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. The device is a liquid medium, not an algorithm.

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

• Type of Ground Truth: For the non-clinical bench testing, the ground truth was derived from direct measurements (pH, osmolality, sterility, endotoxin levels) and established biological assays (Mouse Embryo Assay results: % expanded blastocyst, blastocyst cell number). For the clinical evaluation, the ground truth was "survival and development of frozen and thawed human 2PN embryos and cleavage-stage embryos." This would be best characterized as outcomes data and direct biological observations/measurements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a formulation of media, not an AI/ML device that requires a training set. The "training" for such a device would be the product development and optimization process, not data-driven machine learning.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The development of the media likely involved iterative testing to achieve optimal performance, and the "ground truth" at that stage would be the desired physical/chemical properties and embryo viability outcomes.

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