Search Results

The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is recommended for dilation of the urinary tract.

The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned inside the balloon that define the working length. The balloon catheter can be used to dilate strictures of the urinary tract.

The provided text describes a traditional 510(k) Notification for a medical device, the Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data or performance metrics against specific acceptance criteria for AI/algorithm-based devices.

Therefore, many of the requested details, particularly those related to AI/algorithm performance, ground truth establishment, expert adjudication, and comparative effectiveness studies, are not applicable to this document. The submission relies on engineering and sterility testing, as well as the similarity to an existing device, to establish safety and effectiveness.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission like this are primarily met through demonstrating substantial equivalence to a predicate device and compliance with relevant voluntary standards and performance testing. There are no specific quantifiable acceptance criteria presented in the document in the format of AI performance metrics (e.g., sensitivity, specificity, AUC).

The reported "device performance" is described through a summary of various engineering and material tests, rather than clinical outcomes or diagnostic accuracy.

• Balloon Burst Testing
• Balloon Kink Testing
• Durability Testing (cycle testing)
• Compliance Testing
• Balloon Shape Characteristics Testing
• Balloon Insertion Force Testing
• Balloon Cystoscope Compatibility Testing
• Balloon Deflation Testing |

Details Not Applicable or Not Provided in the Document:

1. Sample size used for the test set and the data provenance: This is not an AI/algorithm device that uses test sets of data for performance evaluation in the typical sense. The "testing" refers to bench testing and material compatibility.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI performance (e.g., diagnostic labels) is not part of this submission.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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. This is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's safety and effectiveness is primarily established through compliance with standards, material properties, and comparison to the predicate device's established safety record.
7. The sample size for the training set: Not applicable. This device does not involve machine learning or training sets.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device