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EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.

EmbryoAssist™ is a defined sterile medium, used by assisted reproduction professionals and intended for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes. The design of EmbryoAssist™ is based on BlastAssist Medium 1 (MediCult's BlastAssist®System K003156). The EmbryoAssist™ medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml polyethylene plastic vials with screw top closures

Here's an analysis of the provided text regarding the acceptance criteria and study for the EmbryoAssist™ device:

Important Note: The provided document is a 510(k) summary for a medical device (EmbryoAssist™), which is a reproductive medium. The information available in these types of summaries focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results for a diagnostic AI device. Therefore, many of the requested points, especially those related to AI algorithm performance (e.g., sample sizes for training/test sets, expert consensus for ground truth, MRMC studies, standalone performance), are not applicable to this type of device and submission.

This document describes a culture medium and its performance is assessed in terms of its ability to support embryo development, which is a biological outcome.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Inferred Criteria: The document directly states the conclusion that the product is "effective and safe for its intended use." The product testing controls listed (sterility, osmolality, pH, endotoxin, MEA, stability) are inherent quality and performance checks for such a biological medium, and the successful completion of these tests implies they met pre-defined acceptance criteria for release. The core acceptance criterion for the 510(k) submission itself is demonstrating substantial equivalence to existing, legally marketed predicate devices.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document states, "EmbryoAssist™ has been tested in a human study." It does not specify the sample size of this human study.
• Data Provenance: The study was a "human study," implying prospective collection since it involved testing the new device. The country of origin is not explicitly stated, but the submission came from MediCult a/s in Denmark.

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

• This question is not applicable as the device is a culture medium, not an AI diagnostic tool. "Ground truth" for this product would be the successful development of embryos or lack thereof, observed by embryologists/clinicians, rather than expert interpretation of images or data. No "experts" were used in the sense of adjudicating diagnostic decisions.

4. Adjudication Method for the Test Set

• Not applicable for this type of device (culture medium). Adjudication methods like 2+1 or 3+1 are used in diagnostic studies (e.g., radiology) where multiple readers assess cases and discrepancies are resolved. This is not relevant to a cell culture medium.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No, an MRMC study was not done. This type of study is specifically for evaluating the performance of human readers, often with and without AI assistance, in interpreting medical images or data. It is not relevant to a cell culture medium.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done

• No, this is not an AI algorithm. This question is not applicable as EmbryoAssist™ is a physical culture medium, not an algorithm.

7. The Type of Ground Truth Used

• For the human study, the "ground truth" would be the biological outcome of embryo culture, such as:
  • Successful fertilization of oocytes.
  • Progression of embryos to the 4-8 cell stage (Day 2 or Day 3).
  • Absence of adverse effects on embryo morphology or viability.
  • Essentially, it's based on observing the biological performance of the medium as intended.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm requiring a training set.

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

• Not applicable. This device is not an AI algorithm and does not have a training set or associated ground truth in that context.

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