(281 days)
RapidVit™ Cleave is indicated for vitrification of day 3 cleavage stage embryos
RapidWarm™ Cleave is indicated for warming of vitrified day 3 cleavage stage embryos
RapidVit™ Cleavage and RapidWarm™ Cleavage are restricted to sale by or on the order of a physician.
RapidVit™ Cleave is used for vitrification of day 3 cleavage stage embryos. The cryoprotectants 1,2-propanediol and ethylene glycol are used together with sucrose for dehydration of the embryo before cryopreservation. Then the embryos are immediately plunged into liquid nitrogen in order to prevent intracellular and extracellular ice crystal formation.
RapidWarm™ Cleave is used for the subsequent warming of vitrified day 3 cleavage stage embryos
The provided document is limited in the detail required to populate all fields of the request. The submission is a 510(k) premarket notification for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with extensive performance metrics and ground truth establishment.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative criteria or success rates in this document. | "Successful vitrification of human cleavage stage embryos by use of RapidVit™ Cleave and RapidWarm™ Cleave has been clinically proven (Balaban et al. 2008)." |
| Substantial equivalence to predicate device (Vit Kit™ - Freeze and Vit Kit™ - Thaw) | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
Missing Information: Specific quantitative acceptance criteria (e.g., survival rate, viability rate, developmental rate post-vitrification/warming) are not detailed in this 510(k) summary. The document states that successful vitrification has been "clinically proven" by a referenced study (Balaban et al. 2008), but the performance metrics from that study are not included in this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not mentioned in this 510(k) summary. The summary refers to a clinical study by "Balaban et al. 2008" but does not provide details about its sample size.
- Data Provenance: Not mentioned in this 510(k) summary. The country of origin and whether the study was retrospective or prospective are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as this device (vitrification/warming kit for embryos) does not involve expert interpretation for ground truth in the way diagnostic imaging algorithms do. Ground truth for embryo vitrification/warming studies typically involves objective biological outcomes.
- Qualifications of Experts: N/A
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. Similar to point 3, this type of device study does not typically involve adjudication of expert opinions for ground truth.
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:
- MRMC Study: No, an MRMC study was not done. This type of study design is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and AI assistance. This device is a biological solution for embryo cryopreservation.
- Effect size of human reader improvement with AI: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a chemical solution used in a clinical procedure. It is not an algorithm, and therefore, "standalone" performance in the context of an algorithm does not apply. The device's performance is inherently tied to its use in a human-orchestrated process (embryo vitrification and warming).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The document refers to "clinical proven" results from the Balaban et al. 2008 study. For embryo vitrification and warming, the ground truth would typically be based on objective biological outcomes such as:
- Embryo survival rates post-warming
- Embryo developmental rates (e.g., reaching blastocyst stage)
- Pregnancy rates
- Live birth rates
The specific outcomes used as ground truth for the "clinically proven" statement are not detailed in this 510(k) summary but would be found in the referenced publication.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is a chemical kit, not an AI/ML algorithm that requires a training set. The "training" in this context would be pre-clinical testing and manufacturing quality control, not data-driven model training.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as explained in point 8.
§ 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.