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The Bard® U-Balloon Dilation Catheter is used for dilation of the urinary tract.

The Bard® U-Balloon Dilation Catheter is indicated for dilation of the urinary tract.

The Bard® U-Balloon Dilation Catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end, The catheter has two radiopaque bands which define the balloon working length and facilitate radiographic visualization and placement. A high pressure stopcock is attached to the inflation lumen.

Here's a breakdown of the acceptance criteria and study information for the Bard U-Balloon Dilation Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria (e.g., "burst pressure must be > X psi") or quantified performance results directly in the document. Instead, it refers to establishing substantial equivalence to a predicate device.

The "performance" is implicitly tied to meeting the requirements outlined in the referenced guidance document for urological balloon dilation catheters to demonstrate substantial equivalence.

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

The document does not provide details on the specific sample size used for performance testing (e.g., number of catheters tested for burst pressure, fatigue, etc.). It only states that "appropriate testing" was completed.

Similarly, there is no information regarding the provenance of any data (e.g., country of origin, retrospective or prospective). Given the nature of a medical device 510(k) for a physical device like a catheter, the "test set" would primarily refer to in-vitro or bench testing, not clinical data in the sense of patient studies.

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

This information is not applicable in the context of this 510(k) summary. "Ground truth" and "experts" in this sense typically refer to clinical or diagnostic imaging studies where expert consensus is needed to label data. For a physical device like a balloon catheter, performance is measured against engineering specifications and physical properties, not diagnostic labels.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data, which is not the type of data or testing described here.

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

An MRMC study was not done and is not applicable. This type of study is used to evaluate the impact of a diagnostic tool (often AI-powered) on human reader performance, typically in interpreting medical images. The Bard U-Balloon Dilation Catheter is a therapeutic physical device, not a diagnostic or imaging interpretation tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

A standalone study was not done and is not applicable. This type of study refers to the performance of an AI algorithm operating independently. The Bard U-Balloon Dilation Catheter is a physical medical device.

7. Type of Ground Truth Used:

The "ground truth" for the performance claims of this device would be established through engineering specifications, material science testing, and adherence to manufacturing standards and regulatory guidance. For example, the "ground truth" for balloon burst pressure would be the actual pressure at which the balloon ruptures during controlled testing. For a device like this, it's about meeting physical and functional parameters, not about diagnostic accuracy against pathology or outcome data.

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument, not an AI/software algorithm that requires a "training set" of data.

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

This information is not applicable for the same reasons as #8.

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