(117 days)
MultiBlast Medium is intended for use as the second stage of a sequential in vitro embryo culture protocol. MultiBlast Medium has been developed to support the growth of human embryos from day three through day five, postfertilization, including blastocyst formation.
MultiBlast Medium is intended for use in the culture of human embryos to the blastocyst stage of development.
MultiBlast Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to support embryonic growth and blastocyst development in vitro.
The provided document is a 510(k) summary for a reproductive medium called MultiBlast Medium, not a study describing a device's performance against acceptance criteria in the typical sense of a medical device with an algorithm or outcome prediction. The document describes the intended use and technological characteristics of the medium and states that it meets criteria outlined in a Notice of Final Rule (63 FR 48428, Docket number 97N-0335).
Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission for an in vitro embryo culture medium.
However, I can extract the information that is present and indicate where information is not available within the provided text.
Acceptance Criteria and Device Performance for MultiBlast Medium
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance |
|---|---|
| Functional for unintended use (support of embryonic growth) | MultiBlast Medium is assayed by mouse embryo assay prior to release to market to assure it is "functional for its intended use, the support of embryonic growth." |
| Absence of toxic components | The mouse embryo assay also assures "that no toxic components are present in the formulation." |
| Sterility | Sterility testing will be performed as a condition of release. |
| Endotoxin levels | Endotoxin testing will be performed as a condition of release. |
| Suitability for intended use, meeting criteria of 63 FR 48428 | The conclusion from performance testing and historical information shows "MultiBlast Medium is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions a "mouse embryo assay" but does not quantify the number of embryos or assays performed for pre-market release or for the historical information.
- Data Provenance: The mouse embryo assay is a routine batch release test. The document also refers to "historical information contained in professional literature" and mentions that the product "has been used in a variety of clinical settings, for its intended use, for a number of years," becoming a "standard media." This suggests the efficacy is based on established clinical use and biological principles, rather than a specific prospective clinical trial designed for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for a culture medium revolves around its biological performance (embryo viability and development). This is assessed via standardized biological assays (mouse embryo assay) and historical clinical use data, not through expert consensus on interpretations of complex data like images.
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Adjudication method for the test set:
- Not Applicable. No adjudication method is described as the performance is based on biological assays and historical clinical use, not interpretations requiring human reader consensus.
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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 a device with an AI component or one that involves human-in-the-loop interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithmic device.
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The type of ground truth used:
- Biological Outcome/Performance: The ground truth is the successful support of embryonic growth and development to the blastocyst stage in vitro, as assessed by a mouse embryo assay and implied by historical clinical use.
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The sample size for the training set:
- Not Applicable. This device is a culture medium, not a machine learning algorithm that requires a training set. The "historical information" and "variety of clinical settings" mentioned are more akin to general clinical experience rather than a structured training set for a computational model.
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How the ground truth for the training set was established:
- Not Applicable. (See #7).
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.