Search Results

This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.

The Direct Peroral Cholangioscopy Balloon is a sterile, single use device used to gain access for direct peroral cholangioscopy. The device is placed through a duodenoscope with a minimum accessory of 2.0 mm. The latex balloon is then anchored within the pancreaticobiliary system to guide forward viewing endoscopes for diagnostic and therapeutic applications. It can also remove biliary stones.

The provided document is a 510(k) summary for the "Direct Peroral Cholangioscopy Balloon." It describes the device, its intended use, and states that it met performance requirements through non-clinical bench testing. However, it does not contain the detailed information requested regarding acceptance criteria, specific performance metrics, or study characteristics like sample size, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted and what is missing:

The device is a "Direct Peroral Cholangioscopy Balloon" used to guide optical and accessory devices in the pancreaticobiliary system and for endoscopic removal of biliary stones.

What's explicitly stated in the document:

• Acceptance Criteria/Performance Data: The document states, "Performance testing consisting of non-clinical bench testing demonstrates that the Direct Peroral Cholangioscopy Balloon met the performance requirements of the expanded intended use." This is a general statement that performance requirements were met, but it does not specify what those requirements were or provide quantitative results.
• Study Type: Non-clinical bench testing.

What is missing from the document (and therefore cannot be provided):

1. A table of acceptance criteria and the reported device performance: This information is not provided in the 510(k) summary. It only states that the device "met the performance requirements."
2. Sample sizes used for the test set and data provenance: No sample sizes are mentioned for the bench testing. Data provenance is not applicable as it's non-clinical bench testing, not human use data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for non-clinical bench testing.
4. Adjudication method for the test set: Not applicable for non-clinical bench testing.
5. 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 device is a medical instrument, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical bench testing, "ground truth" would typically refer to validated measurement standards or engineered specifications, but these specifics are not provided.
8. The sample size for the training set: Not applicable as it's not an AI model.
9. How the ground truth for the training set was established: Not applicable as it's not an AI model.

In summary, the provided document indicates that the device underwent non-clinical bench testing and met performance requirements. However, it does not offer the granular detail requested regarding specific acceptance criteria, quantitative performance results, or study design elements beyond identifying it as bench testing.

Ask a specific question about this device