(381 days)
The intended use of Medi-Cult Sperm Preparation Medium is for sperm washing and for sperm separation by swim-up method, since seminal plasma must be separated from the spermatozoa in order to facilitate capacitation. The selection of motil spermatozoa is done in order to increase the likelihood of fertilization.
The Sperm Preparation Medium is also used as holding medium for the oocytes before ICSI.
Product formulation: Earl's Balanced Salt Solution (EBSS) Sodium Pyruvate Synthetic Serum Replacement (SSR) HEPES Sodium Bicarbonate Human Serum Albumin (HSA) Penicillin Streptomycin Phenol Red
Product testing control contents:
- Bioburden, production-test
- Integrity filter testing, production-test
- Sterility, QC-test
- pH, QC-test
- Osmolarity, QC-test
- Endotoxin, QC-test
- Sperm Survival, QC-test
The provided text describes a 510(k) submission for "Medi-Cult Sperm Preparation Medium" and its approval. It does not contain information about a device that uses an AI algorithm or undergo studies with acceptance criteria in the typical sense for an AI/ML medical device. Instead, it focuses on the performance of a culture medium in IVF clinics by presenting live birth rates.
Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information and indicate where information is not present or not applicable.
Here's a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This type of acceptance criteria (e.g., sensitivity, specificity, AUC) and performance is not relevant for a sperm preparation medium. The "performance" is demonstrated through clinical outcomes in IVF clinics using the product.
| Acceptance Criteria Type | Acceptance Criteria | Device Performance (Reported) |
|---|---|---|
| Clinical Performance (Live Birth Rates) | Not explicitly stated as "acceptance criteria" but implied to be comparable to or better than national averages and other clinics. | Norway (1992-1996): Individual clinics using Medi-Cult showed live birth rates per started cycle ranging from 99.9% (though one value seems errant or misformatted) down to 13.3%, often comparable to or exceeding the national average (e.g., 14.6% to 17.9%). |
| Sweden (1997): Carl von Linne Clinic (only using Medi-Cult) reported 34% birth rate per embryo replacement, "best in Sweden and well above the national average of 25.8%." | ||
| UK (April 1996 - March 1997): Several clinics exclusively using Medi-Cult products showed live birth rates per embryo replacement ranging from 22.3% to 34.5%, generally above the UK national average of 21.8%. | ||
| AIH (Norway, 1988-1998): IVF-Unit University of Trondheim reported 13.4% pregnancy rate per insemination (877 inseminations). | ||
| Safety | No registered complaints or evidence of serious adverse events | "No registered complaints on the product and there is no evidence in the last 1.5 year that the product has been the cause of any serious adverse events in connection with its intent use." |
| Product Testing Controls | Pass/Fail for various QC tests (implied) | Bioburden, Integrity filter testing, Sterility, pH, Osmolarity, Endotoxin, Sperm Survival were all "production-test" or "QC-test," implying they met internal criteria. Specific values are not provided. |
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 (Test Set): This device is a culture medium, not an AI algorithm. The "test set" in this context refers to the clinical data demonstrating its performance.
- Norway IVF: Data from various clinics across 1992-1996. Specific number of cycles not given for each clinic, but for "National average" cycles are implied to be aggregated.
- Sweden IVF (Carl von Linne Clinic): For year 1997, number of cycles not specified, but birth rate per embryo replacement was 34%.
- UK IVF: Several clinics, with specific "Number of IVF-cycles" provided: 503, 852, 388, 650, 68, 163, 1434, 1245, 333, 651. Total national IVF cycles reported as 33520. Data from April 1996 to March 1997.
- Norway AIH (IVF-Unit University of Trondheim): 877 inseminations in the period 1988-1998.
- Data Provenance: Retrospective clinical data collected from IVF units in Norway, Sweden, and the UK.
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)
Not applicable. The "ground truth" here is clinical outcomes (live birth rates, pregnancy rates), which are factual medical events, not interpretations requiring expert consensus as in AI image analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Clinical outcomes are recorded data; no adjudication is involved in their establishment.
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/ML device, and no human reader study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a biological culture medium, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used is clinical outcomes data, specifically:
- Live birth rates per started cycle (Norway)
- Birth rate per embryo replacement (Sweden, UK)
- Pregnancy rate per insemination (Norway AIH)
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The clinical data presented serves as demonstration of performance, not for training a model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this product.
§ 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.