(87 days)
VitriGuard is intended for use as a cryopreservation storage device in vitrification procedures and indicated to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.
VitriGuard is a sterile, single-use device that is intended for use as a cryopreservation storage device in vitrification procedures. The device consists of a two-piece polystyrene assembly that includes a hexagonal-shaped stick and cap. As part of the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining and securing oocytes or embryos. The stick and cap include a taper design that create a seal when assembled. Black markings at the end of the stick and the tip of the device provide visual aid for proper device orientation. All VitriGuard devices have a blue cap and the sticks are available in eight (8) translucent colors: clear, blue, green, yellow, lime green, purple, orange and pink.
Here's a breakdown of the acceptance criteria and the study information for the VitriGuard device, based on the provided text:
VitriGuard Acceptance Criteria and Study Information
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a single table, but are instead derived from the "Substantial Equivalence Comparison" table and "Non-clinical performance testing" sections by comparing the subject device's performance to the predicate device and established standards. The reported device performance is also taken from these sections.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (typically matching predicate or standard) | Reported Device Performance (VitriGuard) |
|---|---|---|
| Cooling Rate | Comparable to cleared oocyte and embryo vitrification devices (Predicate: 10,000°C/min) | 36,377°C/min |
| Warming Rate | Comparable to cleared oocyte and embryo vitrification devices (Predicate: -1,400°C/min) | -2,271°C/min |
| Endotoxin | ≤1.0 EU/device (Predicate) | ≤2.0 EU/device |
| MEA (1-Cell) | ≥80% embryos developed to expanded blastocyst at 96h (Predicate) | ≥80% embryos developed to expanded blastocyst at 96h |
| Sterilization SAL | 10^-6^ (Predicate) | 10^-6^ |
| Number of Uses | Single-use, disposable (Predicate) | Single-use, disposable |
| Sterilization Method | - (Predicate: Ethylene Oxide) | Radiation |
| Materials | - (Predicate: PMMA, Mediprene, Stainless steel) | Polystyrene with black marker bands |
Note on Acceptance Criteria: The document clearly states that differences in cooling/warming rates, endotoxin specifications, materials, and sterilization method "do not raise different questions of safety and effectiveness." This implies that while the values may differ from the predicate, they are still considered acceptable based on existing scientific understanding and relevant standards. For MEA, SAL, and number of uses, the criteria are explicitly met by matching the predicate.
2. Sample size used for the test set and the data provenance
The document indicates that clinical performance was primarily supported by a published literature review on closed-system vitrification devices similar to the subject device, rather than a single, dedicated clinical trial for VitriGuard with a specific test set.
- Literature 1: 33 vitrified/warmed donated oocytes.
- Literature 2: 498 vitrified/warmed donated oocytes.
- Literature 3: 190 vitrified/warmed autologous oocytes.
- Literature 4: Not explicitly stated as a single sample size for the study; reported on "clinical experience" with varying results based on maternal age.
- Literature 5: 89 vitrified/warmed donated oocytes.
- Literature 6: 33 patients, resulting in 16 embryo transfer cycles.
Data Provenance: The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated for each literature reference. These are published studies by various authors (Inoue, Pujol, Perez et al, Gook et al, Pinasco et al, Goldman et al), implying they are likely a mix of prospective and retrospective observations from different clinical settings globally, based on typical scientific publication practices. The document uses this existing literature to support equivalence, rather than conducting a new, primary clinical investigation with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for the literature review refers to outcomes measured in published clinical studies (survival rates, fertilization rates, cleavage rates, blastocyst development rates, implantation rates, pregnancy rates, live birth rates). The interpretation of these outcomes would have been performed by the researchers of those individual studies, but details on expert qualifications for establishing ground truth are not given here.
4. Adjudication method for the test set
This information is not provided in the document. Given that the clinical evidence relies on a review of published literature rather than a new, dedicated clinical study with a specific test set and adjudication panel for the VitriGuard device, no adjudication method specific to VitriGuard's clinical performance assessment is described.
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
This is not applicable. The VitriGuard is a physical cryopreservation storage device, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance. Therefore, an MRMC study or assessment of AI effectiveness for human readers is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The VitriGuard is a physical device, and does not involve an algorithm or human-in-the-loop performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing (e.g., cooling/warming rates, endotoxin, MEA), the ground truth is established through standardized laboratory assays and measurements (e.g., USP for endotoxin, ASTM standards for packaging, ISO standards for sterilization).
For the clinical evidence (literature review), the "ground truth" is derived from clinical outcomes data reported in the referenced published studies. This includes metrics such as:
- Oocyte survival rates
- Fertilization rates
- Cleavage rates
- Blastocyst development rates
- Implantation rates
- Clinical pregnancy rates
- Live birth rates
8. The sample size for the training set
This information is not applicable. The VitriGuard is a physical medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable. As it's not an AI model, there is no training set or ground truth established for one.
§ 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.