(309 days)
SpermFreeze Solution™ is indicated for cryopreservation of human sperm
SpermFreeze Solution™ is a device used for cryopreservation of human sperm. SpermFreeze Solution™ is developed to protect the spermatozoa during the freezing and thawing procedure. The solution contains glycerol as cryoprotectant and sucrose.
Here's a breakdown of the acceptance criteria and the study details for the SpermFreeze Solution™, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for product properties are established for each manufacturing lot of SpermFreeze Solution™. The study then compares the performance of SpermFreeze Solution™ to a predicate device and fresh semen samples in various contexts.
| Product Property / Study Outcome | Acceptance Criterion / Comparison | Reported Device Performance / Study Results |
|---|---|---|
| Manufacturing Lot Specifications: | ||
| pH at +20°C and ambient atmosphere | 7.45 ± 0.2 | No specific numerical result reported for this criterion, but implied to be met for commercialization. |
| Osmolality | 2700 ± 300 mOsm/kg | No specific numerical result reported for this criterion, but implied to be met for commercialization. |
| Sterility Assurance Level (sterile filtration) | 10^3 | No specific numerical result reported for this criterion, but implied to be met for commercialization. |
| Bacterial Endotoxins (LAL assay) | 80%, while SpermFreeze Solution™ has a specification of ≥60% for this test.) | |
| Preclinical and Clinical Study Outcomes: | ||
| DNA integrity (Sperm Chromatin Structure Assay) | No statistically significant differences compared to predicate device | The test showed no statistically significant differences on DNA integrity between SpermFreeze Solution™ and the predicate device (SpermFreezing Medium). |
| Fertilization Rate (ICSI, SpermFreeze Solution™ vs. Fresh Group) | No statistical difference from the fresh group | Fertilization rate for ICSI was 64% in the SpermFreeze Solution™ group vs. 66% in the fresh group (no statistical difference). |
| Fertilization Rate (IVF, SpermFreeze Solution™ vs. Fresh Group) | No statistical difference from the fresh group | Fertilization rate for IVF was 83% in the SpermFreeze Solution™ group vs. 74% in the fresh group (no statistical difference). |
| Pregnancy Rate (ICSI, SpermFreeze Solution™ vs. Fresh Group) | No statistical difference from the fresh group | Pregnancy rate of the SpermFreeze Solution™ group was 50% vs. 33% in the fresh group (no statistical difference). |
| Delivery Rate (ICSI, SpermFreeze Solution™ vs. Fresh Group) | 100% of pregnancies resulting in live birth AND no statistical difference from the fresh group | All pregnancies resulted in delivery of healthy babies (delivery rate of 50% in the SpermFreeze Solution™ group vs. 33% in the fresh group). |
| Overall Conclusion: Safety, Efficiency, and Performance | As safe, efficient, and performs as well as the predicate device (SpermFreezing Medium) | The pre-clinical studies showed "no critical observations or deviations" and results "did not differ from results of the predicate device." The clinical investigation concluded that SpermFreeze Solution™ "can be used for cryopreservation of human spermatozoa" and is "considered to be safe and efficient to use." Overall, it "showed to be as safe, efficient and performs as well as the predicate device." |
2. Sample Sizes and Data Provenance
- Test Set (Pre-clinical):
- Human Sperm Survival Cryopreservation Assay: Not explicitly stated, but performed on "human spermatozoa."
- Sperm Chromatin Structure Assay: Performed on "donated semen."
- Test Set (Clinical):
- Fertilization and Embryo Development Study: The sample size for oocytes or semen samples is not explicitly stated. The study compared oocytes fertilized with frozen/thawed semen (using SpermFreeze Solution™) to oocytes fertilized with semen from fresh ejaculate.
- Pregnancy and Delivery Results: Retrieved from patients with transfer of embryos in the ICSI group. The number of patients is not specified.
- Data Provenance: The studies were performed on human spermatozoa/semen. The country of origin is implicitly Sweden, based on the manufacturer's location and contact information (Vitrolife Sweden AB, Göteborg, SWEDEN). The studies appear to be prospective clinical investigations for the clinical data collected.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" for a test set in the traditional sense of diagnostic AI studies. The outcomes measured (sperm motility, DNA integrity, fertilization rates, pregnancy rates, delivery rates) are objective biological/clinical endpoints typically assessed by lab technicians, embryologists, and fertility specialists as part of standard clinical procedures.
4. Adjudication Method for the Test Set
Not applicable. The biological and clinical outcomes measured (e.g., fertilization rates, pregnancy rates) are generally objective measurements and do not typically involve an adjudication process by multiple experts as would be seen in image-based diagnostic studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) and an AI system might assist or replace them. The SpermFreeze Solution™ is a medium for cryopreservation, and its performance is evaluated based on biological and clinical outcomes, not on human interpretation of outputs.
6. Standalone (Algorithm Only) Performance Study
Not applicable. SpermFreeze Solution™ is a cryopreservation medium, a physical product, not a software algorithm or a device with an AI component that would have standalone performance.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation relies on:
- Objective Laboratory Measurements: pH, osmolality, sterility, bacterial endotoxin levels.
- Biological Assays: Human Sperm Survival Assay (motility), Sperm Chromatin Structure Assay (DNA integrity).
- Clinical Outcomes: Fertilization rates (ICSI and IVF), embryo development, pregnancy rates, and delivery rates for healthy babies.
These are direct measurements of biological function and clinical success, often considered the most robust form of "ground truth" for such devices.
8. Sample Size for the Training Set
Not applicable. This device is a cryopreservation medium, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set 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.