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Found 3 results
510(k) Data Aggregation
(29 days)
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
For percutaneous drainage of abscesses, nephrostomy and other fluids.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a General Purpose Drainage Catheter, stating its substantial equivalence to predicate devices and allowing it to be marketed.
It does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or the nature of test sets.
- The number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth used (pathology, outcomes data, etc.).
- Training set sample size or how its ground truth was established.
Therefore, I cannot fulfill your request for this specific information based on the text provided.
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(27 days)
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER
The Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.
Not Found
This is a 510(k) clearance letter for a General Purpose Drainage Catheter, which is a physical medical device. The document does not describe acceptance criteria, a study proving the device meets criteria, or any AI/algorithm performance. Therefore, I cannot provide the requested information.
Ask a specific question about this device
(27 days)
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL
The UreSil Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.
Not Found
This document is a 510(k) clearance letter from the FDA for a General Purpose Drainage Catheter. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
Based on the provided text, there is no information regarding acceptance criteria related to device performance in terms of algorithms, studies proving performance, sample sizes, expert involvement, or grand truth. The document is a regulatory approval letter, not a clinical trial report or a technical performance evaluation.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them with the provided input.
Ask a specific question about this device
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