Search Results

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.

Ask a specific question about this device

The Transmyometrial Embryo Transfer Sets are used for transferring IVF embryo (s) into the endometrial cavity through the myometrium. These devices are sterile and intended for one time use. The Transmyometerial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted disease, a recent uterine perforation. cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarcan section, a recent pregnancy (or is currently pregnant), or if a patient currently has an intrauterine device.

The Transmyometrial Embryo Transfer Set is used for transferring IVF embryo(s) into the endometrial cavity through the myometrial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted discase, a recent uterine perforation, cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarean section, a recent pregnanty (or is currently program), or if the patient currently has an intrauterine device. The materials used in this device are TFE and 300 Series Stainless Steel. Both materials are widely used in the medical field and biocompatibility is assured.

The provided text is a 510(k) Premarket Notification for a medical device (Transmyometrial Embryo Transfer Set). This type of submission is a regulatory process to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to demonstrate performance against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The submission focuses on demonstrating substantial equivalence based on indications for use, design, construction, and materials, primarily by comparing it to predicate devices from Cook Australia.

Specifically, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not define specific performance metrics or acceptance criteria for the device, nor does it report any performance data against such criteria.
2. Sample size used for the test set and the data provenance: No test sets or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant to a substantial equivalence demonstration for a device of this nature.
4. Adjudication method for the test set: No test sets or adjudication methods are mentioned.
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: This entirely an AI/algorithm-related study type and is not applicable to an embryo transfer set.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there are no performance studies described.
8. The sample size for the training set: Not applicable, as there is no algorithm or 'training set' for this physical medical device.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document states: "The Transmyometrial Embryo Transfer Set is substantially equivalent to other Transmyometrial Embryo Transfer Sets in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Intra-Endometrial Embryo Transfer Set manufactured by Cook Australia." This highlights a comparison of physical and functional attributes to existing devices, not a performance study against acceptance criteria.

Ask a specific question about this device