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The Aqueduct 200 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 200 Cervical Dilation Balloon Catheter is a balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The subject device is an updated version of the Aqueduct 100 Cervical Dilation Balloon Catheter cleared under K160664 that merges two separate dilation balloons into one balloon, removes the anchor balloon, replaces the four-way hub with a three-way hub, and removes the stylet from the shaft. The catheter consists of a 2-lumen shaft. One lumen inflates a cylindrical dilation balloon. A second lumen is for infusion of saline solution and also contains a camera and camera cable. In use, the catheter is inserted through the vagina and cervical canal and into the uterus. Using visual feedback from the forward-looking camera and LED light source the physician advances the catheter through the cervical canal and identifies the end of the canal when entering the internal orifice of the uterus. When the physician identifies the orifice, the catheter is positioned inside the cervix. This aligns the cylindrical dilation balloon at the internal cervical os and external cervical os. The balloon is inflated with 12.5 ml of saline, providing gradual mechanical dilation of the cervix. The camera cable on the catheter connects to a camera module that provides power to the camera and allows connection to an HDMI port on a monitor to assess proper device placement during a clinical procedure. After 3 minutes of dilation of the internal and external orifices of the uterus, a controlled injection of 1-2.5 ml of saline may be made through the catheter infusion lumen which exits on the distal end of the catheter. Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed exiting through the external opening of the cervix. Optimal dilation of 8-9 mm 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 deflation of the balloon is conducted by attaching a luer lock syringe to the swabable valve and removing saline from the balloon. The subject device is packaged in a mylar/Tyvek pouch and ethylene oxide (EO) sterilized to a SAL 10-6. The packaged device has a shelf-life of 15 months.

The provided text describes the Aqueduct 200 Cervical Dilation Balloon Catheter and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical or performance study with human subjects, comparing its effectiveness or accuracy against a ground truth for a diagnostic or therapeutic outcome.

Instead, the document details various non-clinical performance data and testing conducted to demonstrate that the device itself is safe and performs as intended, largely in comparison to its predicate device or against engineering/manufacturing standards.

Below is an attempt to structure an answer based on the available information, with significant caveats that many requested sections are not applicable or not present in the document provided.

Acceptance Criteria and Device Performance Study for Aqueduct 200 Cervical Dilation Balloon Catheter

The provided 510(k) summary for the Aqueduct 200 Cervical Dilation Balloon Catheter (K202433) primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards. It does not appear to describe a study that involves clinical outcomes, diagnostic accuracy, or comparative effectiveness with human readers/AI, as would be typical for certain types of medical devices, especially those involving AI or diagnostic interpretation.

The "acceptance criteria" referred to in the document are primarily engineering and safety standards, and device functionality specifications, rather than clinical efficacy targets.

1. Table of Acceptance Criteria and Reported Device Performance

Since the document does not present acceptance criteria as quantitative targets for clinical performance (e.g., sensitivity, specificity for a diagnostic device), this table will list the types of tests performed and the general outcome reported.

2. Sample Size for Test Set and Data Provenance

This information is not applicable as the document describes non-clinical laboratory and bench testing, not a clinical study with a "test set" of patient data.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The "ground truth" for the tests performed was established by validated engineering standards, laboratory test results, and adherence to regulatory guidance, not expert consensus on clinical cases.

4. Adjudication Method

This information is not applicable. There was no clinical study involving interpretation or adjudication of cases.

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

A MRMC comparative effectiveness study was not performed or reported in this document. This type of study is typically conducted for diagnostic imaging devices or AI tools that assist human readers in interpreting clinical data. This device is a cervical dilation catheter, primarily a mechanical instrument.

6. Standalone Performance Study (Algorithm Only)

A standalone algorithm performance study was not performed or reported. The device includes a camera, but its primary function is visual feedback for proper placement of the mechanical dilation component. It does not appear to involve an AI algorithm for diagnosis or interpretation.

7. Type of Ground Truth Used

The "ground truth" for the reported performance data was based on:

• Validated laboratory methods and equipment: For biocompatibility (cytotoxicity, sensitization, irritation), sterility, EO residuals, packaging integrity.
• Engineering specifications and standards: For electrical safety, EMC, optical performance (e.g., resolution, field of view), and bench performance (e.g., burst pressure, dimensions, bond strength), referenced against ISO and IEC standards.
• Simulated aging conditions: For shelf-life performance testing.

8. Sample Size for the Training Set

This information is not applicable as there is no mention of a training set for an algorithm in the provided document.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no mention of a training set.

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The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.

The Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction.

The provided text describes the 510(k) premarket notification for the Aveta System but does not contain specific acceptance criteria or detailed study results with performance metrics that would typically be found in a clinical study report. The document focuses on demonstrating substantial equivalence to a predicate device.

However, it does list various performance data types that were provided in support of the substantial equivalence determination. Based on these, we can infer the types of acceptance criteria that would have been used, even if the specific numerical thresholds are not explicitly stated.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary, specific numerical acceptance criteria and detailed performance results are not provided. However, the "Performance Data" section (Page 10) lists the types of tests performed, which inherently implies associated acceptance criteria for each. Without the actual study reports, the exact performance values are unknown.

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

• Sample Size for Test Set: Not specified in the provided document. The listed tests are primarily engineering and bench testing, as well as simulated use. No information is given regarding human subject test sets or the number of cases.
• Data Provenance: The tests are indicated as performance data provided in support of substantial equivalence, which typically means the testing was conducted by Meditrina, Inc. (the manufacturer) or a contracted lab. The country of origin for the data is not specified, but the context implies it was generated to meet US FDA requirements. The data is prospective in the sense that Meditrina, Inc. generated it specifically for this premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the document. The tests performed are primarily related to device function, safety, and performance against engineering specifications, rather than clinical diagnostic accuracy requiring ground truth established by experts. "Simulated Use" might involve experts, but the details are not given.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic decisions. The tests listed are not typically subject to such adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document states "Comparative testing to predicate for pressure control, fluid deficit, fluid control and durability." This refers to technical performance comparisons between the devices, not a clinical study assessing human reader performance with and without AI assistance. The Aveta System appears to be a medical device for hysteroscopy procedures with integrated fluid management and resection capabilities, not primarily an AI-driven diagnostic imaging interpretation device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• The Aveta System is a medical device for hysteroscopy, not an AI algorithm. Therefore, a standalone algorithm-only performance assessment, as it pertains to AI/machine learning, is not applicable and was not performed. The "Software Verification and Validation Testing" addresses the software component of the device, but this is distinct from AI-specific standalone performance.

7. The Type of Ground Truth Used

• For the engineering and functional tests, the "ground truth" would be the engineering specifications, regulatory standards (e.g., ISO, IEC, ASTM), and the expected physical or electrical outcomes of the device's operation.
• For "Simulated Use" tests, the ground truth might come from established clinical protocols or expert assessment of the simulation's success.
• For "Comparative testing to predicate," the predicate device's established performance would serve as a benchmark or "ground truth" for comparison.
• Pathology or outcomes data are not explicitly mentioned as ground truth sources for the performance data presented here, although tissue resection is mentioned, implying that the resected tissue would eventually be sent for pathology in actual clinical use.

8. The Sample Size for the Training Set

• This information is not applicable or not provided as the Aveta System is a hardware/software medical device, not an AI/machine learning system that requires a distinct "training set" for model development in the traditional sense. Software verification and validation are performed, but this is testing against specifications, not training a model.

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

• Not applicable, as there is no mention of a "training set" in the context of AI/machine learning for this device.

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