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Delivery of washed sperm into the uterus.

The IUI Catheter is a balloon catheter for intrauterine insemination. The catheter is placed in the uterus and sperm is intracted through the catheter in less than several minutes. The IUI Catheter is a packaged , sterile, disposable, flexible, plastic catheter with two lumens, one for inflation of the balloon and one for injection of washed sperm. A balloon inflation syringe is provided with the product.

The provided text describes a 510(k) summary for the "IUI Catheter" (K120154). This submission is for a medical device that claims substantial equivalence to a predicate device, not for an AI/ML powered device. As such, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sensitivity, specificity, F1-score, reader studies, training sets, and ground truth establishment by experts) are not applicable or detailed in this document.

The acceptance criteria and study information provided focus on the physical and functional characteristics of the traditional medical device, particularly in comparison to its predicate.

Here's an analysis of the provided information based on your request, highlighting where information is absent or not applicable due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The "Equivalence Summary" table on page 2 of the 510(k) document serves as the primary source for acceptance criteria and how the proposed device (IUI Catheter) meets them by demonstrating equivalence to the predicate device.

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is based on demonstrating substantial equivalence to a legally marketed predicate device (Fertiligent Slow Release IUI Catheter K092579). The core argument is that the proposed "IUI Catheter" component is identical to the predicate's IUI catheter component in design, manufacturing, materials, sterilization, and packaging.

The "Non-clinical/Clinical Testing" listed includes:

• Biocompatibility
• Endotoxins
• HSSA testing
• Sterilization validation
• Shelf-life
• Performance testing

The document states: "Since both the proposed and predicate catheters are identical, we feel that the testing performed on the predicate is sufficient to support the safety and effectiveness of the proposed IUI catheter." This implies that new testing for the proposed device was primarily to confirm these characteristics are met, likely mimicking or referencing the predicate's established performance in these areas. For example, Endotoxin testing is explicitly listed with the same acceptance criterion for both.

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

Not applicable in the context of an AI/ML device's test set. This device is a physical medical instrument. The testing mentioned (biocompatibility, endotoxins, etc.) would involve laboratory samples of the device and biological materials, but not patient data or a "test set" in the sense of AI/ML evaluation.

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

Not applicable. There is no "ground truth" to establish for a test set in the context of an AI/ML algorithm. The equivalence is based on physical and functional characteristics, and regulatory standards for safety and performance (e.g., endotoxin limits, biocompatibility).

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

Not applicable. This concept pertains to human review of AI/ML outputs to establish a ground truth.

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

No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

No. This is not an AI/ML algorithm.

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

For the physical device's performance, the "ground truth" would be established by:

• Regulatory standards and established test methods for biocompatibility, sterility, endotoxin levels, and physical performance (e.g., balloon inflation, catheter integrity).
• Comparison to the predicate device's established safety and effectiveness data, leveraging the identical nature of the core catheter component.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set exists for this type of medical device.

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Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.

The IUI Catheter is a balloon catheter for slow release insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The kit includes a standard BD 3 ml syringe and a mechanical actuator, as well as an ancillary component, a leg strap. Sperm is loaded into the syringe which is attached to the IUI catheter. The syringe is placed in a plastic, spring loaded mechanical actuator to press on the syringe plunger and deliver the sperm over a 3-4 hour period.

The provided text describes a 510(k) premarket notification for the "Fertiligent Slow Release IUI Catheter Kit". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically associated with novel technology or diagnostic devices.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies cannot be fully extracted from the provided document.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing: Specific quantitative performance metrics (e.g., success rates, complication rates, time to delivery accuracy) that would constitute "acceptance criteria" for a novel device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: A "small clinical trial" was performed. The exact sample size is not disclosed.
• Data Provenance: Not explicitly stated, but clinical trials are typically prospective. The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable/Not Provided: For a device like an IUI catheter, "ground truth" in the diagnostic sense (e.g., disease diagnosis by expert consensus) is not directly relevant. The assessment of safety and effectiveness in a clinical trial would involve medical professionals observing outcomes, but their role isn't described as "establishing ground truth" in the context of an algorithm's performance.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Provided: Adjudication methods (like 2+1 or 3+1) are typically used for evaluating human or AI interpretations of data where ambiguity exists. This is not described for the clinical trial of an IUI catheter.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. This device is a pure medical device (catheter and mechanical actuator), not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance:

• No: This device is a physical medical device; there is no standalone algorithm to evaluate.

7. Type of Ground Truth Used:

• Outcomes Data/Clinical Observation: For the small clinical trial, the "ground truth" would be the observed clinical outcomes related to the safety and effectiveness of the device (e.g., successful sperm delivery, absence of adverse events). This is inferred from the statement "lent support to the safety and effectiveness."

8. Sample Size for the Training Set:

• Not Applicable: There is no "training set" for an AI algorithm, as this is a physical medical device.

9. How Ground Truth for the Training Set Was Established:

• Not Applicable: As there is no training set for an AI algorithm, this question is not relevant.

Summary of Device and Evidence Presented:

The Fertiligent Slow Release IUI Catheter Kit is a balloon catheter for slow-release intrauterine insemination. The 510(k) submission primarily relies on demonstrating substantial equivalence to an existing legally marketed device (K032835 H/S Catheter) by stating identical technologies, materials, and function.

The evidence for safety and effectiveness includes:

• Non-clinical testing: Biocompatibility, endotoxin, HSSA, sterility validation, mechanical function, and shelf-life testing.
• Clinical testing: A "small clinical trial" which "lent support to the safety and effectiveness of the device." No further details on this trial (sample size, specific results, methodology) are provided in the summary.

Key takeaway: This document is a regulatory submission focused on substantial equivalence, not a detailed scientific paper describing the performance of a novel diagnostic or AI-driven medical device against pre-defined acceptance criteria. Therefore, many of the requested details related to AI/diagnostic performance studies are not present.

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