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Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.

The Shepard Intrauterine Insemination Set consists of a 5.4 French polyethylene tubing catheter with a connector cap and a stainless steel inner cannula with a female luer lock adapter (FLLA) hub. The assembled device measures 20 cm in length. A silicone positioner is placed 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal end is curved, with a closed ended tip rounded to a smooth finish. One sideport is located just proximal to the distal tip.

The Soft-Pass™ Coaxial Insemination Catheter is comprised of a guide catheter and an insemination/transfer catheter. The guide catheter is 6.8 French in diameter and measures 12 cm in length. Ink marks are placed on the distal end of the guide catheter to aid in positioning within the cervical canal. The transfer hub has a female luer adaptor to which the preloaded syringe is affixed. The guide catheter hub and transfer hub connect with a friction fit. The transfer catheter is 4.4 French in diameter.

The Insemi-Cath® is 3.5 French in diameter and has a length of 13 cm. It is manufactured from nylon tubing that tapers gradually from 0.195 inches at the proximal end that accepts a standard slip tip syringe and tapers for the remaining 7 cm of the catheter. The distal end is manufactured in both curved and straight configurations. The curved Insemi-Cath® features a silicone positioner placed approximately 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal tip of the catheter is rounded to a smooth finish and designed with an open end.

The provided document is a 510(k) premarket notification for Cook Intrauterine Insemination Catheters (Trade Name: Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial). It outlines the regulatory approval process and includes a "510(k) Summary" which details the device description, indications for use, comparison to predicate devices, and test data to demonstrate substantial equivalence.

Based on the provided text, the device is a medical device (catheter), not an AI/algorithm-based diagnostic device. Therefore, the questions related to acceptance criteria for AI/algorithm performance, human reader studies (MRMC), standalone algorithm performance, expert ground truth establishment, training set size, and data provenance for AI models are not applicable to this document.

The document discusses acceptance criteria and studies relevant to a medical device's physical and biological performance. Here's a breakdown of the applicable information:

Acceptance Criteria and Study for a Medical Catheter Device

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

2. Sample size used for the test set and the data provenance:

• The document does not specify specific sample sizes for each test (e.g., number of catheters tested for HSSA, aspiration, or leak tests). It generally states "all predetermined acceptance criteria were met" or "tests were performed."
• Data Provenance: The tests are described as being performed to demonstrate the device's performance. The manufacturing entity is Cook Incorporated, based in Bloomington, IN, USA. The testing would presumably be conducted by or for Cook Incorporated. The document does not specify country of origin for test data beyond the company's location. The testing is described as occurring on "newly manufactured" or "aged" devices, implying prospective testing as part of the device's design and manufacturing validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable as the device is a physical medical catheter, not an AI/algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established international standards (e.g., ISO, ASTM, USP) and predefined performance specifications.

4. Adjudication method for the test set:

• This is not applicable for the same reasons as above. Performance is measured against objective, quantifiable criteria established by engineering and biological standards, not subjective expert judgment requiring adjudication.

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 is not applicable. This type of study relates to the performance of AI algorithms in assisting human interpretation (e.g., radiologists reading images). The submitted device is an Intrauterine Insemination Catheter, which does not involve human readers interpreting data.

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

• This is not applicable. The device is a physical catheter, not a standalone algorithm.

7. The type of ground truth used:

• The "ground truth" for this medical device's performance is established by objective laboratory measurements and adherence to recognized industry standards (e.g., ISO 10993 for biocompatibility, AAMI/ANSI, USP for endotoxin, ASTM for shelf life and package integrity, and internal engineering specifications for mechanical properties like aspiration, leak, and tensile strength). For the HSSA test, the "ground truth" is defined as living motile sperm, with a quantitative survival rate.

8. The sample size for the training set:

• This is not applicable. The device is a manufactured medical product, not an AI model requiring a training set.

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

• This is not applicable for the same reasons as above.

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