(312 days)
Liquid Paraffin is used as an overlay to stabilise pH and reduce evaporation during IVF and ICSI procedures.
Medi-Cult Liquid Paraffin
The provided text describes a 510(k) submission for "Medi-Cult Liquid Paraffin," a device used in In-Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) procedures. However, the information provided does not contain the details necessary to answer the questions about acceptance criteria, specific studies, sample sizes, expert involvement, or comparative effectiveness.
The submission focuses on establishing substantial equivalence based on prior extensive use and the absence of complaints, rather than presenting a detailed clinical study with performance metrics against defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that the product "has been used extensively over a number of years to the satisfaction of the users" and "There have been 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." This implies general acceptance and lack of adverse events, but no specific performance metrics or acceptance criteria are defined or reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention a specific test set or a study with defined sample sizes. The claim of "extensive use" and "no registered complaints" points to a general observation of real-world usage rather than a structured clinical trial.
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)
- Cannot be provided. There is no mention of experts establishing a ground truth for a test set. The "satisfaction of the users at the IVF- and ART- clinics and laboratories" refers to the general professional community, not a structured expert review for a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is described.
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
- Cannot be provided. This is not a diagnostic imaging device involving human readers or AI assistance. It is a laboratory reagent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No formal ground truth definition is mentioned. The implicit "ground truth" for safety and effectiveness is inferred from the lack of complaints and satisfactory use in real-world IVF/ART settings, which could be loosely interpreted as "outcomes data" in a very general sense (successful IVF cycles without product-related adverse events), but it's not explicitly defined or measured in a study.
8. The sample size for the training set
- Cannot be provided. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable to this device.
In summary, the provided 510(k) summary relies on historical performance and a lack of adverse events for a product that has been used extensively, rather than detailing a specific study with the requested performance metrics and methodological specifics. This approach is common for certain types of medical devices, particularly those seeking substantial equivalence based on long-standing market presence and established safety profiles.
§ 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.