(196 days)
VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity
The VitaVitro Embryo Transfer Catheters are sterile (ethylene oxide), single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. They have a three-year shelf-life.
The device includes five catheter models that are composed of a transfer catheter and a guide catheter (some with obturator).
The 172 mm length Guide catheters have OD 2.4 mm for straight (Models ET-SI and ET-S) and OD 2.2 mm for the curved version type (Model ET-A).
The curved version type (Model ET-A) has an additional adjustable positioner which aids in positioning the device to the targeted depth within the uterine cavity during a procedure. Both types have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.
The 240 mm transfer catheter with an OD 0.95 mm is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) is connected to the connector of the transfer catheter and is used to deliver the embryos into the uterine cavity.
The 200 mm obturator with OD 1.3 mm is an optional accessory for the device. It has a rounded/blunt closed tip. The obturator is used to provide additional support (increase rigidity) during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.
The provided text describes the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) and its substantial equivalence to a predicate device. However, this document does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance as initially requested in the prompt.
The document details the non-clinical performance data for a medical device (a catheter), not a software or AI-driven diagnostic device. Therefore, the specific questions related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training/test set sample sizes are not applicable to the information provided.
The "acceptance criteria" discussed in the document are related to the physical and biological performance of the catheter, such as sterilization, biocompatibility, and functional integrity.
Here's an attempt to answer the questions based only on the provided text, recognizing that it does not align with the implied context of AI/algorithm performance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Mouse Embryo Assay (MEA): 1-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours. | MEA: All predetermined acceptance criteria were met (implies ≥ 80% embryos developed to expanded blastocyst at 96 hours, though not explicitly stated with a specific percentage). |
| Endotoxin: ) | |
| Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating (per ISO 10993 series) | Biocompatibility: Device material found to be non-cytotoxic, non-sensitizing, and non-irritating. |
| Sterilization: Sterile (ethylene oxide) | Sterilization: ISO 11135-1:2014 & ISO 10993-7:2008 standards met. |
| Package Integrity: Passes ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15 | Package Integrity: All predetermined acceptance criteria were met. |
| Transportation Simulation: Per ASTM D4169-22 | Transportation Simulation: All predetermined acceptance criteria were met. |
| Bench Performance (after accelerated aging): All predetermined acceptance criteria met for: Appearance, Taper/Syringe compatibility, Transfer catheter and obturator compatibility with guide catheter, Dimensional analysis, Distance indication marker location and durability, Dislodgement of positioning ring, Tip drop when held horizontally, Bonding strength of device connections/bonds, Aspiration and leakage testing of transfer catheter, Corrosion resistance of stainless steel tube, Tensile/bonding strength test to assess all joints, Flow rate of transfer catheter | Bench Performance: All predetermined acceptance criteria were met in the listed tests after accelerated aging. |
Regarding the other questions, the provided text does not contain the requested information as it pertains to an embryo transfer catheter and not an AI-powered device:
- Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are lab tests on physical device properties and biological interaction (MEA).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on established laboratory standards and measurements, not expert human interpretation of medical images or data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the listed tests is based on scientific and engineering standards (e.g., ISO for biocompatibility and sterilization, ASTM for mechanical properties, USP for endotoxin), and biological assay results (MEA).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).