(91 days)
Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.
Mineral Oil is used to cover medium during embryo, oocyte, and sperm culture in assisted reproduction technology (ART) and micro-manipulation procedures. Mineral Oil is recommended for use as an overlay for a small volume of medium to prevent evaporation stable osmolality and pH.
The material composition:
High Purity Paraffin Oil comes in two density types:
- Light type has a ratio between 0.8200 to 0.8400 g/mL (15°C) and a viscosity which is between 8.850 to 11.70mm²/s (37.78°C)
- Heavy type has a ratio between 0.8500 to 0.8700 g/mL (15°C) and a viscosity which is between 41.90 to 44.10mm²/s (37.78°C).
There are two types of products, Mineral Oil - Light and Mineral Oil - Heavy. Two different unit sizes (100mL and 50mL) are available for each type. Mineral oils are colorless, tasteless, clear oil fluids which do not produce fluorescence.
Both Mineral Oils (Heavy and Light) do not contact the ova or embryo during culture. Mineral Oil is filter sterilized and dispensed into sterile light-resistant glass bottles.
The provided text describes a 510(k) premarket notification for a medical device called "Mineral Oil" used in assisted reproductive technology. This is not the type of document that typically includes information about acceptance criteria and a study proving the device meets those criteria, as one would find for a software-based AI/ML medical device.
The document is a US FDA 510(k) clearance letter and summary for a physical product (Mineral Oil) which functions as a reproductive media supplement. It aims to demonstrate "substantial equivalence" to a predicate device rather than independently proving safety and efficacy through extensive clinical studies and AI performance metrics.
Therefore, many of the requested categories for acceptance criteria and study details for an AI/ML device are not applicable or cannot be extracted from this document. However, I can extract the "non-clinical performance data" which serves as the "acceptance criteria" and "device performance" for this specific product, as well as some details about its testing.
Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available:
1. Table of Acceptance Criteria and Reported Device Performance & 7. The type of ground truth used:
The acceptance criteria for this non-AI/ML device are based on non-clinical performance tests designed to establish substantial equivalence concerning safety and effectiveness. The "ground truth" here is essentially the compliance with these established biological and chemical specifications.
| Acceptance Criteria (Non-Clinical Performance Tests) | Reported Device Performance (Mineral Oil) | Ground Truth Type |
|---|---|---|
| Appearance (color): clear, particle free | Clear, particle free | Predefined chemical/physical specification |
| Sterility: No microbial growth from sterility testing per USP | No microbial growth | USP Standard |
| Endotoxin Testing: 80% of 1-cell control embryos develop at 96 hours | >80% of 1-cell control embryos develop at 96 hours | Biological assay (embryo development) |
| Peroxide Value (POV): | No discoloration, color of sulfuric acid layer paler than control | USP Standard |
| Shelf-life testing | Demonstrated 12 months shelf-life | Stability testing |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify exact sample sizes for each non-clinical performance test. It only states that tests were completed. Data provenance is not detailed beyond the manufacturer being "KITAZATO BioPharma Co., Ltd." in Japan. The tests are non-clinical (laboratory-based), not human data, so "retrospective or prospective" does not apply in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for these non-clinical tests is based on established laboratory standards (e.g., USP , ), chemical specifications, and biological assay outcomes, rather than expert interpretation of medical images or patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for non-clinical laboratory tests.
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 for a physical medical device (mineral oil), not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not an algorithm.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set. The "device" itself is the mineral oil which is manufactured according to specifications.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML 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.