(162 days)
The Nest VT Vitrification Device is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.
The subject devices, Cook Nest VT Vitrification Devices, are sterile, single-use assisted reproduction storage devices for use in vitrification procedures to contain and maintain oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos. The Cook Nest VT Vitrification Devices are composed of a stick (124.5 mm) and cap (38.5 mm) design with a combined length of 136.5 mm, a 35 mm space for notations, and a 6 mm long loading well. Visible marks are on the distal tip end, on the body of the stick and at the opening of the cap, which are created through laser etching to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The stick and cap include a taper design that create a seal when assembled. All the subject devices included in this submission are identical except for their color. There are 5 different colors: blue, purple, red, yellow, and green. The subject devices are sterilized using gamma radiation to a sterilization assurance level of 10-9, are one-time use, and have a 2 year shelf-life. During the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick and the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage.
The provided document is a 510(k) summary for the "Nest VT Vitrification Device". It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance testing. However, it does not contain information on a study proving the device meets acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance, or the establishment of ground truth by multiple experts.
The document describes the device as a "cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos." The performance testing discussed (sterilization, endotoxin, cooling/warming rates, MEA testing, package integrity, mechanical performance) are related to the physical and biological compatibility of the device itself, not to an AI or diagnostic algorithm's performance.
Therefore, I cannot fulfill your request as the provided text does not describe a study involving an AI or algorithm, nor does it detail acceptance criteria and performance data for such a system. The questions you posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document does not concern.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.