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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.

AI/ML Overview

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.

Acceptance Criterion (Item)	Predicate Device Specification	Proposed Device Performance (Specification)	Comments/Discussion
Components	Mechanical Actuator, Insemination Syringe, Leg Strap, IUI Catheter	Not included (for first three), IUI Catheter	Proposed device does not include Mechanical Actuator, Insemination Syringe, or Leg Strap as they are specific to the predicate's "Slow Release" function, which is not part of the proposed device's "bolus injection" intended use. The IUI Catheter component is identical to the predicate.
Indication for Use	Delivery of approx. 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.	Delivery of washed sperm into the uterus.	Proposed device is for standard IUI use (injection over a shorter period). Considered as "Comparable use for both products."
Use (Insemination Duration)	3-4 hour insemination	< several minutes	Proposed device is identical to predicate, and biocompatibility concerns are reduced due to shorter sperm contact duration compared to the predicate's cleared 4-hour contact. "Acceptance criteria are the same for both proposed and predicate devices."
Endotoxin Testing	< 20EU/device	< 20EU/device	Proposed and predicate devices are the same in terms of endotoxin limits.

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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