(391 days)
"Medi-Cult Embryo Freezing Medium" is for freezing of early (2-8 cell stage) embryos.
"Medi-Cult Embryo Freezing Medium" is to be used with cryoprotectants for freezing and thawing of embryos. It is a phosphate buffered salt solution containing Assisted Reproduction Technique Supplement (ARTS) and Human Serum Albumin (HSA).
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Medi-Cult Embryo Freezing Medium" device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define specific numerical acceptance criteria for the device's performance. Instead, it relies on demonstrating that the device performs comparably to or better than a national average or other established clinical outcomes.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| High Pregnancy Rate | Trondheim, Norway (1988-1998): 17.0% pregnancy rate per embryo replacement |
| Oslo, Norway (1994-1996): 18.3% pregnancy rate per embryo replacement | |
| (Compared to irrelevant national average for Norway, noted as not meaningful) | |
| High Birth Rate | Carl von Linne Clinic, Sweden (1997): 22% birth rate per frozen embryo replacement |
| UK Clinics using Medi-Cult (April 1996 - March 1997): Live birth rates ranging from 7.8% to 27.1% | |
| UK National Average (for comparison): 12.1% live birth rate per embryo replacement | |
| No Complaints/Adverse Events | "No registered complaints on the product and no evidence in the last 1.5 year that the product has been the cause of any serious adverse events." |
| User Satisfaction | "used extensively over a number of years to the satisfaction of the users at the IVF- and ART- clinics and laboratories." |
2. Sample Sizes Used for the Test Set and Data Provenance
The studies presented are retrospective clinical data from various IVF clinics.
- University of Trondheim, Norway:
- Sample Size (Test Set): 966 embryo replacements
- Data Provenance: Retrospective clinical data from Norway.
- The National Hospital, Oslo, Norway:
- Sample Size (Test Set): 465 embryo replacements
- Data Provenance: Retrospective clinical data from Norway.
- Carl von Linne Clinic, Sweden:
- Sample Size (Test Set): Not explicitly stated, but refers to "their birth rate per frozen embryo replacement."
- Data Provenance: Retrospective clinical data from Sweden.
- UK Clinics (Chelsea and Westminster, CARE at Park, Woking Nuffield, Leeds General Infirmary, Nurture, Holly House, Guy's and St Thomas):
- Sample Size (Test Set):
- Chelsea and Westminster Hospital: 24 FER-cycles
- CARE at Park Hospital: 95 FER-cycles
- The Woking Nuffield Hospital: 38 FER-cycles
- Leeds General Infirmary: 333 FER-cycles
- Nurture: 104 FER-cycles
- Holly House Fertility and IVF: 115 FER-cycles
- Guy's and St Thomas Assisted Conception Unit: 651 FER-cycles
- Total (sum of listed clinics): ~1360 FER-cycles
- Data Provenance: Retrospective clinical data from the UK, collected by the Human Fertilisation and Embryology Authority (HFEA).
- Sample Size (Test Set):
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The submission does not describe a process where explicit "experts" were used to establish a ground truth for a test set in the conventional sense of an AI/medical device study. The "ground truth" here is the actual clinical outcome (pregnancy or live birth) of IVF cycles, which are established through standard medical procedures and clinical records by the medical staff (doctors, embryologists, nurses) at the respective IVF clinics. No specific number or qualifications of these "experts" are provided, as they are inherent to the standard clinical practice where the data originated.
4. Adjudication Method for the Test Set
No adjudication method is described. The outcomes (clinical pregnancies, live births) are direct clinical results, not interpretations requiring adjudication by multiple parties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a culture medium, not an imaging or diagnostic device that involves human readers interpreting output. The studies compare the device's performance (clinical outcomes) against existing national averages or other clinics, not against human readers with and without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not directly applicable. The device is a "freezing medium," not an algorithm. The studies assess the performance of the medium itself within the existing human-driven clinical process of IVF. There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The ground truth used in these studies is clinical outcomes data:
- Clinical pregnancies: Confirmed pregnancies.
- Live birth rates: Confirmed live births.
8. The Sample Size for the Training Set
The submission does not describe a separate "training set" in the context of an AI/machine learning model. The data presented are historical clinical outcomes used to demonstrate the device's acceptable performance, which could be considered analogous to validation data for a medical product. The product itself, being a medium, is not "trained."
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of a machine learning model for this device, this question is not applicable. The product's formulation is based on scientific research and data published in peer-reviewed journals, and its performance is demonstrated by the clinical outcome data mentioned in section 7.
§ 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.