(43 days)
VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. It is single-use, disposable, and provided sterile. The device consists of a two-piece polystyrene assembly that includes a hexagonalshaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, and capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining, and securing the embryos. The stick and cap include a taper design that creates a seal when assembled. Markings at the end of the stick and the tip of the device provide visual aid for proper device orientation.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cooling rate | Not explicitly stated | -2,271°C/min |
| Warming rate | Not explicitly stated | 36,377°C/min |
| Sterilization | SAL 10⁻⁶ | Radiation, SAL 10⁻⁶ |
| Endotoxin | ≤2.0 EU/device | ≤2.0 EU/device |
| Mouse Embryo Assay (MEA) | ≥80% blastocyst at 96h | Met the predetermined acceptance criteria (≥80% blastocyst at 96h) |
Note on Cooling/Warming rates: While listed as "Specifications," the document does not explicitly state them as "acceptance criteria" where a threshold needs to be met for the study. They are presented as inherent characteristics of the device. However, for the purpose of demonstrating device performance, they are included here. The MEA is the only one explicitly stated as meeting "predetermined acceptance criteria."
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The text mentions "VitriGuard devices" and "One-cell mouse embryos" without specifying a number per test.
- Data provenance: Not explicitly stated. However, given it's a pre-market submission, the study was likely conducted specifically for this submission and would be considered prospective for the device's regulatory approval. The study uses mouse embryos, which are a biological model, not human data from a specific country.
3. 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 the Mouse Embryo Assay (MEA) is established based on the biological outcome of embryo development (percent blastocyst formation), not through expert consensus or interpretation of images/data. Therefore, no "experts" were required to establish ground truth in this context.
4. Adjudication method for the test set
Not applicable. As noted above, the ground truth for the MEA is a direct biological outcome, not a subjective assessment requiring 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 not an AI-assisted diagnostic tool; it is a physical cryopreservation storage device. Therefore, 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 not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the key performance test (Mouse Embryo Assay) was biological outcome data, specifically the successful development of mouse embryos to the blastocyst stage.
8. The sample size for the training set
Not applicable. This device is a physical product, not a machine learning model. There is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.