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The Aqueduct 100 Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.

The Aqueduct 100 Cervical Dilator is a triple-balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The catheter consists of a 3-lumen shaft. One lumen inflates an anchoring balloon. A second lumen inflates the 2 cylindrical dilation balloons. The third lumen is for infusion of saline solution and also contains a fixed stiffening stylet to add rigidity to the catheter. The stylet is permanently sealed within the infusion lumen. In use, the catheter is inserted through the vagina and cervical canal and into the uterus where the distal spherical balloon is inflated. The catheter is then withdrawn until the spherical balloon comes into contact with the internal orifice of the uterus, which positions and anchors the catheter within the cervix. This aligns the two cylindrical balloons at the internal cervical os and external cervical os. The balloons are inflated with saline providing gradual mechanical dilation of the cervix.

After 3 minutes of dilation of the internal and external orifices of the uterus, a gentle, controlled injection of 1ml, and up to 2.5ml, of saline can be made through the catheter infusion lumen which exits between the two balloons (and inside the cervical canal). Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed entering through the external opening of the cervix. Optimal dilation of 8-9mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes.

The Aqueduct 100 Cervical Dilator is packaged in a mylar/Tyvek pouch and EO sterilized to SAL 10-6.

The provided document describes the Aqueduct 100 Cervical Dilation Balloon Catheter and its substantial equivalence determination, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/human reader study.

The document indicates "Performance Data" were provided in support of the substantial equivalence determination, but these refer to biocompatibility and in vitro performance tests relevant to the device's physical properties and safety, not a clinical study involving human readers or AI performance.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria for AI/human performance, study design details, expert qualifications, etc.) is not present in the provided text.

The closest information provided is:

1. A table of acceptance criteria and the reported device performance: This information is not provided for an AI or human reader study. The document lists the following in vitro performance tests:

2. Sample size used for the test set and the data provenance: Not applicable, as no such study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on the physical and material equivalence of the Aqueduct 100 Cervical Dilation Balloon Catheter to its predicates based on biocompatibility and in vitro performance testing, not on clinical performance or diagnostic accuracy improved by AI or human readers.

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