(426 days)
The HSV Straw 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.
An embryo is vitrified using the HSV Straw by placing an embryo suspended in a 0.5ul All entrification solution solution in a curved polymeric spatula (Medical Grade. Styrene-Butadiene Copolymer). The curved spatula is inserted in an outer straw with a Styrene-Butadiene Coporymer). The open, proximal end of the straw is sealed by the user. The sealed, weighted unsal Chd. The open, promishar effect freezing-vitrification. The weighted straw seated straw is placed in liquid nitrogen for embryo storage. Thawing-rewarming: While the remains in liquid nitrogen, part of the outer tube is cut away. The curved spatial, distal tip tellians in inquir mirogen, part of the outer straw and immediately immersed in thawing solution where thawing and dilution of the remaining vitrification solution occur simultaneously.
The provided text describes the HSV Straw, a cryopreservation device, and compares it to predicate devices for substantial equivalence. It does not contain information about a study with acceptance criteria and reported device performance in the format of a table as requested, nor does it detail AI-assisted studies or specific ground truth methodologies in the usual sense of clinical diagnostic devices.
However, based on the provided text, I can extract information related to the device's performance through various tests and a clinical study, which implicitly serve as "acceptance criteria" for regulatory clearance.
Here's an attempt to structure the available information, keeping in mind that some requested fields might not be directly applicable or explicitly stated in the document's context (e.g., AI-specific details, number of experts for ground truth, adjudication methods).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful completion of the tests and studies presented for substantial equivalence. The "performance" is demonstrated by the device meeting these criteria (e.g., high embryo survival rates, absence of adverse effects).
| Criteria Type (Implied) | Acceptance Criteria (Implied from predicate comparison and successful testing) | Reported Device Performance (HSV Straw) |
|---|---|---|
| Embryo Survival Rate (Mouse Embryo Assay - MEA) | 90-100% survival rate for blastocysts at 96 hours. (Based on predicate performance and successful MEA testing) | 90-100% survival at 96 hours |
| Endotoxin Level | 80% post-vitrification/rewarming survival. (Implied acceptability based on successful study outcomes) | >80% post-vitrification/rewarming embryo survival in each of the three clinical centers. |
| Absence of Device Associated Adverse Effects | No device-associated adverse effects. | No device associated adverse effects were experienced by the study sites. |
| Protection from Nitrogen Contamination | Embryos protected from nitrogen contamination inside a sealed straw. | Design information demonstrated protection of embryos from nitrogen contamination. |
| Successful Pregnancies and Live Births | Successful use of vitrified embryos for pregnancies and live births. | The three centers had high levels of embryo survival after thawing and successfully used the vitrified embryos for pregnancies and live births. |
2. Sample Size Used for the Test Set and Data Provenance
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Clinical Study Test Set:
- Sample Size: 473 vitrification cycles, utilizing 1509 human embryos.
- Data Provenance: The study was conducted in "three centers representing diverse approaches to assisted fertility". The geographical location (country of origin) is not explicitly stated, but the manufacturer is French (Cryo Bio System, Paris, France). Given the FDA submission, it's possible these centers were in the US or collaborating internationally. The study appears to be prospective as it describes the routine use and continued use of the device in these centers.
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Mouse Embryo Assay (MEA):
- Sample Size: Not explicitly stated, but performed with "mouse blastocysts".
- Data Provenance: Laboratory testing, likely internal or contracted, provenance not specified beyond "laboratory". Retrospective/Prospective not applicable in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided in the document.
- For the clinical study, "three centers" were involved. It is implicitly understood that fertility specialists, embryologists, and other qualified healthcare professionals at these centers would have assessed embryo survival and clinical outcomes. However, the exact number and detailed qualifications of specific experts establishing "ground truth" (e.g., for embryo viability assessment) are not specified.
- For the MEA, embryologists or laboratory technicians would assess mouse embryo survival.
4. Adjudication Method for the Test Set
This information is not explicitly provided in the document. For embryo survival and clinical outcomes in the clinical study, it's likely standard clinical practice and consensus among the operating professionals at each center. There's no mention of a formal adjudication panel (e.g., 2+1, 3+1).
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
- No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, particularly one involving AI assistance, was not conducted or described. This document pertains to a cryopreservation device, not an image-reading or diagnostic AI system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm but a physical medical device. Therefore, a standalone algorithm-only performance study is not applicable.
7. The Type of Ground Truth Used
- Clinical Study: "Ground truth" was established based on clinical outcomes (human embryo survival after vitrification/rewarming, successful pregnancies, and live births) as assessed by the participating fertility centers. These are objective clinical endpoints.
- Mouse Embryo Assay (MEA): "Ground truth" was established by embryo viability assessment at 96 hours post-thaw.
- Other Tests: Ground truth for endotoxin was based on quantitative laboratory measurements, and for mechanical testing, it was based on functional performance metrics. Cooling/rewarming rates were empirically measured.
8. The Sample Size for the Training Set
- This concept is not applicable as this document describes a physical medical device submission, not an AI model requiring a training set. The clinical study described served as a test set for the device's performance.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (see point 8).
§ 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.