(359 days)
V-ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development.
V-ONESTEP is a medium for culturing human embryos following fertilization up to day 6 of development. The device is provided sterile-filtered into pre-sterilized 20 ml glass or 10 ml PETG bottles. V-ONESTEP has a shelf-life of 90 days when stored at 2-8°C and can be use for seven days after opening bottles.
The provided text describes the 510(k) summary for V-ONESTEP, a reproductive medium. Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) | Predicate Device Criteria (for comparison) |
|---|---|---|---|
| pH | 7.2-7.4 | 7.20-7.4 (Likely a range, actual results stated as 7.20-7.4) | 7.2-7.6 |
| Osmolality | 257-273 mOsm/kg | 257-273 mOsm/kg (Likely a range, actual results stated as 257-273 mOsm/kg) | 250-290 mOsm/kg |
| Endotoxin (per USP) | ) | No growth | No growth |
2. Sample Size Used for the Test Set and Data Provenance
The text explicitly mentions a "1-cell mouse embryo assay (MEA)" as part of the performance testing.
- Sample Size: The text states, "One-cell mouse embryos were exposed to the subject device..." but does not specify the number of embryos used in this assay. It also mentions "in comparison with the control group" but doesn't elaborate on the size of the control group.
- Data Provenance: Not specified. It's unclear where the mouse embryos originated or if the study was retrospective or prospective, though performance testing for device clearance is typically prospective lab-based testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For this type of device (reproductive media), the ground truth is established through laboratory assays (MEA, pH, osmolality, endotoxin, sterility) rather than expert review of images or clinical outcomes. The device's performance is objectively measured against pre-defined thresholds.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, the ground truth is based on objective laboratory measurements, not expert consensus or adjudication.
5. 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
- Not Applicable. This device is a reproductive medium, not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a fluid for culturing embryos; there is no algorithm or AI component. The "standalone performance" refers to the intrinsic performance of the medium itself as measured by the assays mentioned.
7. The Type of Ground Truth Used
- The ground truth for the performance evaluation relies on objective laboratory measurements based on established scientific methods and regulatory standards:
- Chemical parameters: pH, osmolality.
- Biological assay: 1-cell MEA (development to expanded blastocyst stage).
- Contamination assessment: Endotoxin levels, Sterility (no growth).
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The formulation of the medium itself is developed through research and experimentation, but there isn't a "training set" like in machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question doesn't apply. The development of the medium's formulation would be based on scientific knowledge of embryo development requirements.
§ 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.