(133 days)
These products are intended for the in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The media can also be used for transfer.
The SAGE 1-Step 11 medium is intended for in vitro fertilization and culture of human gametes and embryos from fertilization until Day 5/6 of development. The medium can also be used for transfer. Two versions of the SAGE 1-Step™ medium are available: Catalogue no. 6701: SAGE 1-Step™ supplemented with Human Serum Albumin. Catalogue no. 6702: SAGE 1-Step™ supplemented with Serum Protein Supplement. Both versions of SAGE 1-Step™ are aseptically filtered, light pink, non viscous solutions, which are ready to use by professionals within assisted reproduction. The SAGE 1-Step™ media products are contained in 10 ml or 60 ml transparent Polyethylene Terephthalate Glvcol (PETG) bottles with high density polyethylene (HDPE) cap, available in a card boxes of 1 x 10 ml and 1 x 60 ml bottles. The bottles are individually labeled. The boxes also contain instruction for use provided as package insert.
The provided document describes the SAGE 1-Step™ culture medium for in vitro fertilization and embryo culture, comparing it to a predicate device, Global® Total®. The focus of the document is on establishing substantial equivalence to the predicate device, not on presenting a standalone study or a comparative effectiveness study with human readers and AI. Therefore, I can only address aspects related to the product specifications and how they compare to acceptance criteria, which are derived from the predicate device's performance.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" for clinical performance, but rather compares the SAGE 1-Step™ to a predicate device's specifications. The implicit acceptance criterion for SAGE 1-Step™ is that its performance and specifications should be "comparable" or "similar" to the predicate, or that any differences do not raise new safety or effectiveness concerns.
| Performance Characteristic | Acceptance Criteria (from Predicate Global® Total®) | Reported SAGE 1-Step™ Performance (REF 6701 & 6702) | Outcome |
|---|---|---|---|
| pH | 7.2-7.4 | 7.2-7.4 | Meets |
| Osmolality (mOsm/kg) | 260-270 | 257-273 | Meets (slight wider range but considered acceptable) |
| Endotoxin (EU/mL) | 80% | ≥80% | Meets |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical performance study using patient data. The performance data presented are primarily based on product specifications and laboratory tests (like Mouse Embryo Assay - MEA). Therefore, information regarding sample size used for a test set, its country of origin, or whether it was retrospective or prospective, is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there is no human-involved "test set" or clinical study described where ground truth would need to be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human-involved "test set" or clinical study described that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes the technical comparison of a culture medium with a predicate device, not the comparison of human readers with and without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study in the context of an algorithm's performance was not done. This document concerns a medical device (culture medium), not a diagnostic algorithm or AI. The product specifications mentioned (pH, osmolality, endotoxin, sterility, MEA) can be considered a type of "standalone" performance assessment for the medium itself, but not in the context of an AI algorithm.
7. The Type of Ground Truth Used
For the product specifications (pH, osmolality, endotoxin, sterility, 1-cell MEA), the "ground truth" is established through laboratory testing and validated analytical methods as per industry standards and regulatory requirements. For the Mouse Embryo Assay (MEA), the typical ground truth involves observing successful embryo development (e.g., to blastocyst stage) in a controlled environment, indicating the medium's suitability for supporting growth.
8. The Sample Size for the Training Set
There is no training set in the context of an AI algorithm described in this document. The development of SAGE 1-Step™ is based on established scientific principles of embryo culture and comparison with existing, cleared devices.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI algorithm. The "ground truth" for the development and validation of the SAGE 1-Step™ medium itself would be based on fundamental biological and chemical principles, experimental data from studies on embryo culture, and the historical performance data of the predicate device and other similar media.
§ 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.