(152 days)
Allwin Embryo Transfer Catheters are used to introduce in vitro fertilized (IVF) embryos into the uterine cavity. Allwin Embryo Transfer Catheters (Pro Embryo Trans, Pro Echo Trans, Twinkle Pro Embryo Trans, and Bulb Trans Star ETC) include stylets or soft obturators intended to assist in uterine access of the guide catheter during an embryo transfer procedure.
Allwin Stylets and Soft Obturators are intended to be used with Allwin Embryo Transfer Catheters to assist in uterine access of the guide catheter during an embryo transfer procedure.
Allwin ETC include the following models: Embryo Trans, Twinkle Embryo Trans, Bulb Trans Ultra, Bulb Trans Star, Pro Embryo Trans, and Twinkle Pro Embryo Trans Embryo Transfer Catheter.
Allwin ETC Stylets and Soft Obturators include the following models: Stylet For Embryo Trans / Twinkle Embryo Trans, Stylet For Pro Embryo Trans / Pro Echo Trans / Twinkle Pro Embryo Trans, Stylet for Bulb Trans Ultra / Bulb Trans Star, Soft Obturator For Pro Embryo Trans / Twinkle Pro Embryo Trans Embryo Transfer Catheter.
This FDA 510(k) clearance letter pertains to Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets, and Soft Obturators. It is a clearance for a medical device, not an AI/ML algorithm. Therefore, the provided text does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, a study proving its performance, sample sizes, expert involvement, or ground truth establishment.
The document discusses the regulatory process for medical devices and confirms that the Allwin devices are substantially equivalent to legally marketed predicate devices. It outlines the "Indications for Use" for these physical medical devices, but there is no mention of any AI or software component requiring performance evaluation as described in the prompt.
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, or details about experts and ground truth as these are not relevant to the content of this specific FDA letter.
§ 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).