(26 days)
The Kahn Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula, and Neal Fallopian Cannula are indicated to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and filling them with carbon dioxide gas.
The V. Mueller® Uterine Cannula devices are constructed with a stopcock, finger ring control, an elongate shaft and a distal end with a rubber acorn.
The provided text describes the 510(k) summary for Uterine Cannulas, focusing on demonstrating substantial equivalence to a predicate device due to a "material modification". This submission is for a medical device, not an AI/ML powered device, so many of the requested categories (e.g., sample size for test/training sets, number of experts, MRMC studies, standalone algorithm performance) are not applicable.
However, I can extract the relevant acceptance criteria and study information provided for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 / AC 2010 | PASS |
| Functionality | Plating Thickness Analysis | PASS |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission concerns a physical medical device (Uterine Cannula) and its material modification, not an AI/ML algorithm requiring a test set of data. The performance evaluations are based on non-clinical tests (biocompatibility and functionality).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically understood for AI/ML device evaluations (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is established by adherence to recognized standards for biocompatibility and engineering analysis for functionality.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not an AI/ML device requiring adjudication of results from a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for the device's performance is based on established international standards for biocompatibility (ISO 10993-1:2009 / AC 2010) and engineering analysis (Plating Thickness Analysis) for functionality.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this physical medical device.
§ 884.1300 Uterotubal carbon dioxide insufflator and accessories.
(a)
Identification. A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.(b)
Classification. Class II (performance standards).