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Daylily Single Use Sterile Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.

Daylily Single Use Sterile Embryo Transfer Catheters are sterile single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. All models of the Daylily Single Use Sterile Embryo Transfer Catheters consist of a transfer catheter and a guide catheter. Some device models (Type II and Type IV) also include a trial catheter.

The guide catheter is composed of a catheter shaft, connector, and a positioning ring (for certain Type III and IV variants). Guide catheters for some Type III and Type IV variants are also provided pre-curved. Guide catheters 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 transfer catheter is composed of a catheter shaft, connector, and a stainless-steel sleeve (for Type III and IV models). Transfer catheters have a rounded/blunt tip and marker bands at the proximal end of the catheter to aid in catheter placement. The transfer catheter is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) connected to the connector of the transfer catheter is used to deliver the embryos into the uterine cavity.

The trial catheter is an optional accessory for specific models (Types II and IV), composed of a catheter shaft, connector, and a polymer-coated stainless-steel core. Trial catheters have a rounded/blunt closed tip. The trial catheter is used to provide additional support 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 Daylily Single Use Sterile Embryo Transfer Catheters and reports on the non-clinical performance data to support its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the numerical sample sizes for each test set (e.g., number of catheters tested for dimensional analysis, number of mice/embryos for MEA). It only mentions that "all predetermined acceptance criteria were met in the following tests."

The data provenance (e.g., country of origin, retrospective/prospective) is not provided. The manufacturer is Shanghai Horizon Medical Technology Co., Ltd. from China, suggesting the testing likely occurred in or was overseen by a facility associated with the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an embryo transfer catheter and the studies performed are non-clinical, primarily bench performance and biocompatibility tests. Therefore, it does not involve establishing ground truth from expert clinical interpretation (like in imaging AI devices). The "ground truth" for these tests are the defined acceptance criteria and standardized test procedures (e.g., ISO, ASTM standards, FDA guidance).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human interpretation of data requiring adjudication. The tests are objective measurements against predefined specifications.

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

Not applicable. This device is a physical medical device (embryo transfer catheter), not an AI-powered diagnostic or assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance studies are the predetermined acceptance criteria based on established industry standards and regulatory guidance. For example:

• Biocompatibility: ISO 10993 series standards define acceptable biological responses.
• Endotoxin: USP <85> and AAMI/ANSI ST72:2019 define acceptable endotoxin levels.
• Mouse Embryo Assay (MEA): The 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" sets the specification for embryo development.
• Other Bench Tests: Conformity to physical and functional specifications.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. Since there is no training set, this question is not relevant.

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