(121 days)
Vit Kit® - Freeze (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Vit Kit® - Thaw (Vitrification Thaw Kit) is intended for use in the thawing of vitrified oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The five media that comprise the two kits, Vit Kit® - Freeze and the Vit Kit® - Thaw are all based upon a modified formulation of Medium 199 is HEPES buffered and contains 20% (v/v) dextran substitute supplement (DSS), 35μ.g/mL gentamicin and varying concentrations of dimethyl sulfoxide (DMSO), ethylene glycol (EG), and sucrose. The two freeze media in the Vit Kit® - Freeze are intended to be used sequentially, for the preparation and cryopreservation of PN, day 3 cleavage stage, and blastocyst stage embryos and oocytes.
The three thaw media in the Vit Kit®- Thaw are intended for sequential use in the thawing and recovery of cryopreserved human PN, cleavage stage, and blastocyst embryos and oocytes.
The provided text describes the acceptance criteria and a clinical study conducted for the Vit Kit® - Freeze and Vit Kit® - Thaw products, specifically to support the expanded indication for use to include oocytes (MII).
Here's an analysis of the provided information to address your request:
1. A table of acceptance criteria and the reported device performance
The document presents product specifications that act as acceptance criteria for the manufacturing release of the media, and then discusses clinical performance.
Product Specifications (Acceptance Criteria & Reported Performance):
| Final Product Test Specification | Vit Kit® - Freeze (K093273 & K160006) | Vit Kit® - Thaw (K093273 & K160006) |
|---|---|---|
| ES Freeze 90131 | VS Freeze 90132 | |
| Appearance | Pass | Pass |
| pH | 7.05 - 7.54 | 7.05 - 7.54 |
| Osmolality (mOsm/KgH2O) | 1,055 – 1,445 | 1,100 - 1,588 |
| Endotoxin (EU/mL) | 0.03 - 0.60 | 0.03 - 0.60 |
| Sterility | Pass | Pass |
| Modified Mouse Embryo Assay (% of Control) | 80 - 100 | 80 - 100 |
| Albumin Recovery (%) | 85 - 200 | 85 - 200 |
Note: The table above reflects the identical specifications for both the predicate and proposed device, implying these are the acceptance criteria that the device meets "prior to their release for sale." The document states "Results of all release assays performed are reported on a lot-specific certificate of analysis, and are indicated on the labeling," confirming they meet these criteria.
Clinical Performance (Acceptance Criteria & Reported Performance for Oocyte Vitrification):
The clinical study aimed to demonstrate comparability between frozen oocyte transfers (using the Vit Kit) and fresh oocyte transfers. The implicit acceptance criteria are that the performance metrics for frozen oocytes are acceptable and comparable to fresh oocytes, and generally align with established ART success rates.
| Clinical Performance Metric | Fresh Oocytes (Reported Performance) | Frozen Oocytes (Reported Performance) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| % Fertilized | (Baseline, numerical value not given, but implied higher than frozen) | 15% lower than fresh oocytes | Acceptable, as it "did not impact the % Implantation Rate/Transfer and % Pregnancy Rate/Transfer" |
| % Implantation Rate/Transfer | (Baseline) | Comparable to fresh oocytes | Comparable to fresh oocytes |
| % Pregnancy Rate/Transfer | (Baseline) | Comparable to fresh oocytes | Comparable to fresh oocytes |
| % Live Births/Transfer | Lower than frozen oocytes in study; Comparable to CDC 2013 data | Higher than fresh oocytes in study; Similar to CDC 2013 data | Acceptable and/or similar/higher than fresh oocytes and/or CDC data |
| % Live Births/Pregnancy | Comparable to CDC 2013 data | Significantly higher than CDC 2013 data | Acceptable and/or similar/higher than fresh oocytes and/or CDC data |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: "up to 400 patients" volunteered.
- Data Provenance:
- Type: Prospective, multicenter clinical study.
- Country of Origin: Not explicitly stated, but given FDA submission, it's highly likely to be primarily US-based, potentially with international centers typical for multicenter studies. However, this is an inference, not directly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This study is a clinical trial involving patients and the outcomes of IVF procedures (fertilization, implantation, pregnancy, live birth). The "ground truth" for these metrics (e.g., successful fertilization, confirmed pregnancy, live birth) is established through standard medical procedures and clinical observation, not through expert consensus on image review or similar subjective assessments. Therefore, the concept of "experts establishing ground truth for the test set" in the context of radiologists or similar is not directly applicable here. The outcomes are objective clinical endpoints.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a clinical trial assessing device performance on biological samples and patient outcomes, not an imaging study requiring expert adjudication of interpretations. The clinical outcomes are observed and recorded.
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 is not an AI/imaging study, but rather a study of a medical device (vitrification media) and its clinical effectiveness. No human "readers" or AI assistance are involved in the assessment of the outcomes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The "performance" is the efficacy of the media in cryopreservation and its impact on subsequent clinical outcomes.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
The ground truth is outcomes data directly observed in human patients undergoing IVF:
- Fertilization rates
- Implantation rates
- Pregnancy rates
- Live birth rates
8. The sample size for the training set
Not applicable. This is a medical device (chemical media), not an algorithmic or AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device. The product formulation is based on scientific principles of cryopreservation. The product's consistent performance is validated through non-clinical assays (Part 1, Table 1) and clinical performance (Part 1, Table 2).
§ 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.