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510(k) Data Aggregation
(75 days)
Indicated for use in dilation of the ureter or urethra through the working channel of an endoscope.
The Bard® A-Trac™ Urological Balloon Dilation Catheter is a multilumen catheter with a discrete balloon mounted on its distal tip. The clear lumen, labeled "balloon", is for balloon inflation. The lumen, labeled "distal", allows the catheter to track over a guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium. The catheter shaft gradually tapers beneath the balloon, nominally one French size. The tip is further tapered to provide a smooth interface with a Bard 0.035" PTFE-coated guidewire. Two radiopaque markers are placed beneath the "working area" of the balloon. The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a balloon folding tool prior to sterilization. A stylette is inserted in the distal (guidewire) lumen beneath the balloon folding tool. The Bard® A-Trac™ Urological Balloon Dilation Catheter is available in various models incorporating balloon diameters (inflated) of 4mm-10mm; balloon lengths of 2, 3, 4, 8 and 10 cm; shaft lengths ranging from 45 to 125cm (standard lengths of 45, 75, 85 and 125cm); and shaft diameter of 5 Fr. (for balloons with inflated diameters < 10mm) or 5.8 Fr. (for balloons with 10mm inflated diameter). The device is provided sterile for one time use only and is not intended to be re-used or re-sterilized. Guidewires that may be required for a particular procedure are not packaged with the balloon dilatation catheter and must be obtained separately.
This document describes a medical device, the Bard® A-Trac™ Urological Balloon Dilation Catheter, and its performance characteristics. However, it does not contain information about a study that assesses the device against specific acceptance criteria for a diagnostic or AI-driven medical device.
The provided text is a 510(K) summary, which focuses on comparing the device to a predicate device and outlining its design, materials, and basic performance specifications (like inflation pressure and balloon growth). It's more about demonstrating substantial equivalence and basic functionality rather than presenting a clinical study with quantifiable performance metrics against specific acceptance criteria in the way you've requested for a device that, for example, makes a diagnostic claim or utilizes AI.
Therefore, I cannot populate the table or answer most of your detailed questions as the necessary information is not present in the provided text.
Here's a breakdown of why the information is not available and what the text does provide:
Key missing information relevant to your request:
- Acceptance Criteria for a diagnostic/AI device: The document describes engineering specifications (e.g., maximum balloon growth, burst pressure). These are not diagnostic acceptance criteria like sensitivity, specificity, or accuracy.
- Study Design for performance evaluation: There's no mention of a formal clinical study, test set, ground truth, experts, adjudication, MRMC, or standalone performance evaluation in the context of a diagnostic or AI device.
- Human-in-the-loop performance: This device is a manual catheter; there's no "human-in-the-loop" in the sense of a human interpreting AI output.
- Training set: As it's not an AI/diagnostic device, there's no mention of a training set.
Information that can be extracted (though not fitting neatly into your requested table structure):
While the text doesn't explicitly state "acceptance criteria" in the format you requested for a diagnostic device, it does lay out performance specifications that could be considered internal engineering acceptance criteria for the physical device.
Here's what the document states about the device's performance characteristics:
| Characteristic | Reported Performance |
|---|---|
| Inflation to Stated Diameter/Length | Each balloon inflates to the stated diameter and length at a specific pressure (typically between 3 and 4 atms). |
| Maximum Balloon Growth (Diameter or Length) over Working Pressure Range | Less than 15%. |
| Pre-inflation | All balloons are preinflated to full size. |
| Maximum Recommended Inflation Pressure (Burst Pressure) | For inflated balloon diameters <10mm: Not to exceed 15 atm (99.9% of balloons, at a 95% confidence level, will not burst at or below this pressure upon a single inflation).For 10mm inflated balloon diameter: Not to exceed 13 atm (99.9% of balloons, at a 95% confidence level, will not burst at or below this pressure upon a single inflation). |
Regarding the other questions:
- Sample size for the test set and data provenance: Not applicable/not provided. This isn't a diagnostic performance study. The "test set" would be the manufacturing quality control testing, but specific numbers and provenance for such tests are not detailed here.
- Number of experts used to establish ground truth & qualifications: Not applicable/not provided. Ground truth in a diagnostic sense is not relevant here.
- Adjudication method: Not applicable/not provided.
- MRMC comparative effectiveness study: No. This is a physical device, not an AI or diagnostic tool where such a study would be performed.
- Standalone performance (algorithm only): Not applicable. There is no algorithm.
- Type of ground truth used: Not applicable in the diagnostic sense. The "ground truth" for the device's physical properties would be its engineering specifications and measurements.
- Sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a medical device (a catheter) and its engineering specifications rather than the performance of a diagnostic algorithm or AI system. Therefore, most of your questions are not appropriate for the information provided.
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