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EmbryoAssist™ and EmbryoAssist™ with Phenol Red are for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.

EmbryoAssist™ and EmbryoAssist™ with Phenol Red are each a defined sterile media used by professionals within assisted reproduction and intended for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3. The composition of EmbryoAssist™ and EmbryoAssist™ with Phenol Red are almost identical to The predicate device Embryo Assist™ (K061309), but with an extension of the intended use including a transfer indication. The EmbryoAssist" medium is a salt solution containing SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml and 60 ml polyethylene plastic vials with screw top closures.

The provided 510(k) summary for EmbryoAssist™ and EmbryoAssist™ with Phenol Red describes a medical device, a cell culture medium, rather than a diagnostic AI device. Therefore, many of the requested categories related to AI specific performance, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this submission.

However, I can extract the information that is present and relevant to the "acceptance criteria" (implied functional and safety requirements) and the "study that proves the device meets the acceptance criteria" from the provided text.

Acceptance Criteria and Device Performance

The core acceptance criteria for this type of device (reproductive media) revolve around its safety and effectiveness for its intended use, which is fertilization, culture until the 2-8 cell stage, and embryo transfer. The primary way this is demonstrated for a 510(k) submission is through substantial equivalence to a legally marketed predicate device.

Study Information

As this is a 510(k) for an in vitro diagnostic/culture medium, the "study" is a human clinical study aimed at demonstrating safety and effectiveness, leveraging the concept of substantial equivalence.

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

   • Sample Size: Not explicitly stated in the provided text. It mentions "a human study" but does not give the number of participants or embryos.
   • Data Provenance: The study was "a human study." The sponsoring company, MediCult a/s, is located in Denmark, suggesting the study may have been conducted there or in a similar regulatory environment, but this is not explicitly stated. It is a prospective study as it states "During our studies there have been no registered complaints," implying current data collection.

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

   • Not Applicable. This is a cell culture medium, not an AI diagnostic device where expert ground truth is typically assigned to images or patient data. The "ground truth" here is the biological outcome of the cultures and transfers.

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

   • Not Applicable. See point 2.

4. 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. This is not an AI device.

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

   • Not Applicable. This is not an AI device.

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

   • For this type of device, the "ground truth" would be the observed biological outcomes (e.g., successful fertilization, embryo development to the 2-8 cell stage, successful transfer leading to pregnancy/live birth outcomes – although the latter is often not required for 510(k) for culture media, usually focusing on early embryological development and safety). The text specifically states: "The results showed that the product is effective and safe for its intended use." This efficacy is based on the biological performance observed in the human study.

7. The sample size for the training set:

   • Not Applicable. This is not an AI device, so there is no training set in the AI sense.

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

   • Not Applicable. See point 7.

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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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