(197 days)
The Towako Transmyometrial Embryo Transfer Set is indicated for transfering IVF embryo(s) into the endometrial cavity through the myometrium for patients undergoing Assisted Reproductive Procedures.
The Towako Transmyometrial Embryo Transfer Set is comprised of an echo tipped stainless steel 19 Gauge needle, matching stainless steel stylet and a 2 Fr polyethylene transfer catheter. The stylet fits into the needle with both bevels flush, and is inserted with the stylet in-situ to prevent blockage of the needle lumen and provide stiffness to the needle during insertion. When the needle is positioned correctly, the stylet is removed and the transfer catheter with the embryos loaded is inserted to allow embryo transfer. The device is used when difficulty is experienced in transferring embryos into the uterine cavity using a standard trans-cervical route. The Towako Transmyometrial Embryo Transfer Set is a sterile and single-use device.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Towako Transmyometrial Embryo Transfer Set." It describes the device, its intended use, comparison to a predicate device, and performance data.
However, the document does not contain information about a study involving an AI/Machine Learning device and its performance against acceptance criteria. The listed performance data pertains to traditional medical device testing such as biocompatibility, mouse embryo assay, endotoxin testing, mechanical performance testing, and stability testing. There is no mention of a test set, ground truth, expert readers, or any other elements related to the evaluation of an AI algorithm as requested in your prompt.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The text describes the regulatory clearance process for a physical medical device, not a software or AI medical device.
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).