(98 days)
GM501 Mineral Oil is intended for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedures.
GM501 Mineral Oil is light, mineral oil (paraffin oil) which is used to overlay cell culture media during Assisted Reproductive Technology (ART) or In Vitro Fertilization (IVF) procedures. The oil overlay is intended to protect the culture medium from evaporation in the incubator, limiting potential temperature, osmolality and pH changes in the medium.
GM501 Mineral Oil is aseptically filtered and provided in bottles of 100 ml and 500 ml. This product has an 18-month shelf-life when stored as recommended.
The provided text appears to be an FDA 510(k) summary for a medical device called "GM501 Mineral Oil." It does not describe an AI medical device or a study involving human readers or AI.
Therefore, I cannot provide the information requested for acceptance criteria and a study proving a device meets these criteria, especially concerning AI, human readers, or expert evaluations. The document focuses on demonstrating substantial equivalence of a mineral oil product to a predicate device, based on similar indications for use, materials, specifications, and shelf-life, rather than providing performance data from a clinical or AI-specific study.
The closest information provided to "acceptance criteria" are the "Specification" values in the table on page 4, which are chemical and biological characteristics of the mineral oil product rather than performance metrics for an AI algorithm.
Table of Acceptance Criteria and Reported Device Performance (based on provided text):
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Density | 0.83-0.86 g/ml | Not explicitly reported as a measured value for the subject device, but implied to meet specification by "Performance testing to support the subject device... supports the device specifications." |
| Viscosity | ) | No growth |
| Endotoxins (LAL, USP) |
§ 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.