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Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.

Ultra RapidWarm Blast is intended for warming vitrified human blastocyst stage embryos. The device consists of a single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose.

The medium is aseptically filtered into gamma sterilized 5 mL PETG bottles with HDPE closures and a tamper evident seal. The medium can be used for up to 14 days after bottle opening.

The provided text describes the 510(k) summary for Vitrolife Sweden AB's Ultra RapidWarm™ Blast, a device indicated for warming vitrified human blastocyst stage embryos. The document focuses on demonstrating substantial equivalence to a predicate device (RapidWarm™ Blast, K101003).

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

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

The document lists several specifications, particularly under "Summary of Non-Clinical Performance Testing," as part of the shelf-life testing. These serve as acceptance criteria for the device's performance.

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

• Non-Clinical Testing (Shelf-life): The text indicates that shelf-life testing was conducted, including "aged samples demonstrating that medium in bottles can maintain their specifications after 14 days of simulated use conditioning after bottle opening." However, specific sample sizes (e.g., number of bottles, number of batches, number of MEA replicates) for these non-clinical tests are not explicitly stated in the provided document.
• Clinical Performance Testing:
  • Pilot Study: 86 cycles (52 blastocysts in the control group and 42 blastocysts in the treatment group).
  • Cohort Study: 868 cycles (578 blastocysts in the control group and 336 blastocysts in the treatment group).
  • Data Provenance: The clinical study was conducted in a university-based IVF center in France. The study design was prospective (pilot study followed by a cohort study).

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

The document does not provide information regarding the number of experts, their qualifications, or their role in establishing ground truth for either the non-clinical or clinical test sets. The clinical study compares treatment groups based on clinical endpoints like embryo survival, clinical pregnancy rate, and live birth rate, which are typically objectively measured outcomes rather than expert consensus on a subjective assessment.

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

The document does not describe any adjudication method for establishing ground truth or evaluating the results of the studies. Clinical outcomes (embryo survival, clinical pregnancy rate, live birth rate) are generally direct measurements and do not typically require adjudication in the same way as, for example, image interpretation by 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:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a warming medium for embryos, not an AI-assisted diagnostic device that would involve human readers interpreting AI outputs. The clinical study compared different warming protocols (single-step vs. standard) using a surrogate device and clinical outcomes.

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

Not applicable. This device is a warming medium, not an algorithm. Its performance is evaluated through direct measurement of its specifications and clinical outcomes, not through an algorithm's output.

7. The type of ground truth used:

• Non-Clinical Testing: The ground truth for non-clinical performance (sterility, endotoxins, pH, osmolality, MEA) is based on laboratory analytical methods and established acceptance criteria/specifications. For MEA, it's the observed developmental success of embryos.
• Clinical Performance Testing: The ground truth for clinical performance is based on observed clinical outcomes data (embryo survival rate, clinical pregnancy rate, and live birth rate) from a prospective clinical study.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

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