(463 days)
"Medi-Cult Universal IVF Medium" is for fertilisation of human oocytes and culture of fertilised oocytes up to the 4-6-cell stage (day 2 after insemination). "Medi-Cult Universal IVF Medium" can also be used as vehicle during embryo transfer.
The products: "Medi-Cult Universal IVF Medium" Cat.No. 1031 - "Medi-Cult Universal IVF Medium w/o Phenol" Cat.No. 1030 - "Medi-Cult Universal IVF Medium w/o Pen/Strep" Cat.No. 1095 - Product formulation: Earl's Balanced Salt Solution (EBSS) Sodium Pyruvate Assisted Reproduction Technology Supplement (ARTS) Sodium Bicarbonate Human Serum Albumin (HSA) Penicillin (Except product 1095) Streptomycin (Except product 1095) Phenol Red (Except product 1030)
The provided text describes the 510(k) summary for "Medi-Cult Universal IVF Medium" and its variants. This is a medical device, specifically a culture medium for in-vitro fertilization. The information focuses on demonstrating its substantial equivalence to previously marketed devices and its safety and effectiveness.
Here's an analysis of the acceptance criteria and study data based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly tied to the performance of existing, legally marketed IVF culture media, aiming for "equally well or better." The primary performance metric presented is live birth rates.
| Acceptance Criteria (Implicit) | Reported Device Performance (Medi-Cult Universal IVF Medium) |
|---|---|
| Live birth rates per started cycle should be comparable to or better than national averages and/or other established IVF media. | Norway (1992-1996): Live birth rates per started cycle in clinics using Medi-Cult media (e.g., Univ of Trondheim: 22.2% - 25.35%; National Hospital, Oslo: 13.3% - 19.0%) were generally comparable to or above the national average (14.6% - 17.9%). |
| Sweden (1997): Carl von Linne Clinic (using only Medi-Cult products) reported a 34% birth rate per embryo replacement, which was "the best in Sweden and well above the national average of 25.8%." | |
| UK (April 1996 - March 1997): Live birth rates per embryo replacement in clinics exclusively using Medi-Cult products ranged from 22.3% to 34.5%, with most exceeding the UK national average of 21.8%. | |
| No evidence of serious adverse events. | No evidence in the last 1.5 years that the product has been the cause of any serious adverse events. |
| Mouse Embryo Assay: > 80% hatched | Performed during QC-test (details of specific results not provided in the summary, but stated as a control content, implying compliance). |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" here refers to the clinical data used to support the claim of substantial equivalence and performance.
- Norway: Data collected from 1992 to 1996 from the largest IVF clinics in Norway. The exact number of cycles for individual clinics is specified:
- Dept of Ob & Gyn, Univ of Trondheim: 92-96 data (specific counts per year not given but aggregate for the period is implied by the percentages).
- The National Hospital, Oslo: 92-96 data (specific counts per year not given).
- National average is also provided.
- Provenance: Country of origin is Norway, data is retrospective.
- Sweden: Data from 1997 for the Carl von Linne Clinic. "Birth rate per embryo replacement was 34%."
- Provenance: Country of origin is Sweden, data is retrospective.
- United Kingdom: Clinical data from April 1996 to March 1997 from specific UK IVF clinics.
- Northamptonshire Fertility service: 503 IVF-cycles
- The Bridge Centre: 852 IVF-cycles
- Chelsea and Westminster Hospital: 388 IVF-cycles
- CARE at Park Hospital: 650 IVF-cycles
- BMI Ross Hall Hospital: 68 IVF-cycles
- The Woking Nuffield Hospital: 163 IVF-cycles
- Leeds General Infirmary: 1434 IVF-cycles
- Nurture: 1245 IVF-cycles
- Holly House Fertility and IVF: 333 IVF-cycles
- Guy's and St Thomas Assisted Conception Unit: 651 IVF-cycles
- UK national average: 33520 IVF-cycles
- Provenance: Country of origin is the UK, data is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the establishment of ground truth by experts in the traditional sense of a study where experts label data. Instead, the "ground truth" (live birth rates, etc.) is derived from actual clinical outcomes reported by licensed IVF clinics. These outcomes are typically recorded by clinical staff (doctors, embryologists, nurses) as part of their routine practice. The data for the UK was collected by the Human Fertilization and Embryology Authority (HFEA), a regulatory body that consolidates clinical data from all licensed centers.
4. Adjudication Method for the Test Set
No explicit adjudication method is mentioned. The data presented are reported clinical outcomes, likely gathered according to standard clinical and national reporting procedures in each country.
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
An MRMC study is not applicable here as this is a medical device (culture medium), not an AI diagnostic or assistance tool for human readers. There is no "human reader" involved in the direct assessment of the medium's performance in the way an AI would assist.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is an IVF culture medium, not an algorithm. Its performance is inherent to its biological and chemical properties, measured by clinical outcomes.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary ground truth used is outcomes data, specifically:
- Live birth rates per started cycle.
- Live birth rates per embryo replacement.
- The Mouse Embryo Assay (a biological quality control test with a > 80% hatched criterion) also serves as a ground truth for product quality.
8. The Sample Size for the Training Set
This document describes clinical performance data used for regulatory submission rather than a typical machine learning "training set." The product's formulation and initial development would have involved extensive laboratory research and testing. The clinical data presented here is more analogous to a "validation" or "performance evaluation" set for a traditional medical device, demonstrating its performance in real-world clinical settings compared to benchmarks. There isn't a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" with ground truth establishment in the AI context isn't directly applicable here. The product's development would have been guided by established scientific principles for cell culture media, including optimizing formulation (Earl's Balanced Salt Solution, ARTS, etc.), and undergoing rigorous in-house quality control testing (e.g., bioburden, sterility, pH, osmolarity, endotoxin, and the Mouse Embryo Assay), which serve as internal "ground truths" for product quality before broader clinical use. The clinical performance data then served to validate its efficacy in human IVF.
§ 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.