(223 days)
Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.
The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes.
This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.
The provided text does not contain information about an AI device or a study comparing AI with human readers. It describes a submission for a medical device called "Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50," which is a reproductive medium used for oocyte retrieval.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI device or human-in-the-loop performance. The document focuses on demonstrating the substantial equivalence of the Oocyte Retrieval Buffer to a legally marketed predicate device through non-clinical performance testing.
However, I can extract the acceptance criteria and a summary of the non-clinical performance testing for the described Genea Biomedx Gems Oocyte Retrieval Buffer device.
Acceptance Criteria and Reported Device Performance (Table for the Oocyte Retrieval Buffer)
| Acceptance Criteria | Reported Device Performance (at release and end of shelf-life) |
|---|---|
| pH | 7.3-7.5 (comparable to predicate) |
| Osmolality | 280-290 mOsm/kg (comparable to predicate) |
| 1-cell MEA (Mouse Embryo Assay) | ≥80% developed to the blastocyst stage at 96 hours |
| Endotoxin | for sterility, USP for endotoxin, ISO standards for biocompatibility, and a pre-defined blastocyst development rate for MEA). |
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The sample size for the training set: Not applicable. This document pertains to a medical product, not an AI model requiring a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.