(55 days)
SynVitro Cumulase™ is used by professionals within assisted reproduction for the removal of the cell complex (cumulus and corona radiata) surrounding the oocyte in the preparation for intracytoplasmatic sperm injection (ICSI).
SynVitro Cumulase™ is indicated for the removal of the cell complex (cumulus and corona radiate) surrounding the oocyte in preparation for the ICSI procedure.
SynVitro®Cumulase™ is a sterile non preserved solution containing 80 U/mL of recombinant Synther Camandase (rHuPH20) in a HEPES buffered salt solution with SSR (Synthetic serum replacement) added.
The provided document describes the acceptance criteria and the study for the SynVitro®Cumulase™ device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Efficacy in removing cumulus cells prior to ICSI (compared to predicate device) | The study showed that SynVitro®Cumulase™ and the predicate device (MediCult's SynVitro®Hyadase) were equally effective for removal of cumulus cells prior to ICSI. |
| Biocompatibility (as it is not in contact with the patient) | Not applicable, as the product is not in contact with the patient. |
| Cytotoxicity | Each batch is cytotoxicity tested. |
| Sterility (Ph. Eur. and USP) | Each batch is tested according to Ph. Eur. and USP for sterility. |
| Osmolality | Each batch is tested for osmolality. |
| pH | Each batch is tested for pH. |
| Stability | Stability studies have been performed. |
| Absence of serious adverse events or registered complaints | There have been no registered complaints and no evidence of any serious adverse events in connection with the intended use during the studies. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "The efficiency of removing the cumulus from the oocytes have been compared to the predicated device in a prospective, randomised clinical study."
- Sample Size for Test Set: The specific sample size (number of patients or oocytes) for this clinical study is not explicitly mentioned in the provided text.
- Data Provenance: The study was a "prospective, randomised clinical study," indicating that data was collected specifically for this study in a prospective manner. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts used or their qualifications to establish ground truth for the clinical study. The assessment of "efficiency of removing the cumulus from the oocytes" would typically involve embryologists or fertility specialists, but this is not detailed.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for evaluating the results of the clinical study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This device is a medical product (a solution/reagent) used in assisted reproduction, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is a chemical reagent, not a standalone algorithm. Therefore, a standalone performance study as described is not applicable and was not performed.
7. The Type of Ground Truth Used:
For the primary efficacy endpoint (efficiency of cumulus removal), the ground truth was likely established through direct observation and evaluation by trained professionals (e.g., embryologists) in the context of the prospective clinical study. This would fall under expert observation/assessment based on established laboratory protocols in assisted reproduction.
8. The Sample Size for the Training Set:
This device is a chemical reagent, not a machine learning algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set was Established:
As explained above, a "training set" is not applicable for this type of device.
§ 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.