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510(k) Data Aggregation
(233 days)
Advance Biliary Balloon Catheter
The Advance Biliary Balloon Catheter is indicated for laparoscopic and general surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.
The Advance Biliary Balloon Catheter is a sterile, one-time use, device. The device is a doublelumen catheter manufactured with a nylon shaft. The distal tip of the catheter consists of a nylon balloon and is available in diameters of 6 and 8 millimeters, and a length of 4.0 centimeters. The Advance Biliary Balloon Catheter accepts a 0.035-inch diameter wire guide.
This document pertains to a 510(k) premarket notification for a medical device called the "Advance Biliary Balloon Catheter," not an AI/ML device or software. Therefore, the questions related to AI/ML device performance metrics, such as ground truth, expert adjudication, training/test sets, and AI assistance effects on human readers, are not applicable to the information provided in this document.
The document discusses the substantial equivalence of the Advance Biliary Balloon Catheter to a predicate device (Taut Biliary Balloon Catheter) based on engineering performance tests and biocompatibility, not on a study proving diagnostic or clinical performance determined by an algorithm.
Here's what can be extracted from the provided text regarding acceptance criteria and device performance for this specific medical device:
1. A table of acceptance criteria and the reported device performance:
The document describes several performance tests conducted to ensure the device meets its design input requirements. While it doesn't present these in a formal "acceptance criteria vs. reported performance" table with precise numerical values, it states that the test results "indicated an acceptable" or "appropriate" outcome for each criterion.
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility | Leveraged data from previously cleared devices (K033875, K091527) to mitigate biocompatibility concerns. Demonstrated safety for intended use and duration. |
| Balloon Burst Pressure | Test results indicated an acceptable balloon burst pressure. |
| Balloon Compliance | Test results indicated acceptable balloon compliance. |
| Tensile of Distal Bond of Balloon to Catheter Shaft | Test results indicated that the bond strength is appropriate. |
| Fatigue Test (Balloon stability) | Test results indicate that the balloon fatigue is appropriate. |
| Tensile Test of Hub-to-Shaft Bond | Test results indicated that the bond strength is appropriate. |
| Tensile Test of Proximal Bond of Balloon to Catheter Shaft | Test results indicated that the bond strength is appropriate. |
| Tensile Test of Tip-to-Shaft Bond | Test results indicated that the bond strength is appropriate. |
| Tensile Test of Soft Tip Bond | Test results indicated that the bond strength is appropriate. |
The following questions are not applicable as the document describes a traditional medical device (catheter) and its physical and mechanical performance testing, not an AI/ML diagnostic or predictive device:
- Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Adjudication method (e.g., 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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