Search Results

The Hemodialysis Venous Blood Tubing Set is intended for use as the extracorporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

The proposed hemodialysis venous blood tubing sets raise no new issues of safety or effectiveness. No new claims or indications are made. The venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the venous bloodlines have been tested for biocompatibility and data provided. The integrity of the bonded connections of the bloodlines have been tested and data provided. Sterilization method and packaging are the same as the predicate devices.

The provided text does not contain information about the acceptance criteria and study particulars for a medical device in the context of an AI/ML or comparative effectiveness study. The document is a 510(k) summary for a hemodialysis venous blood tubing set, which is a physical medical device, not a diagnostic AI tool.

The document discusses:

• The substantial equivalence of the blood tubing set to existing legally marketed bloodlines.
• Functional testing of the bloodlines.
• Biocompatibility testing of blood contact materials.
• Integrity testing of bonded connections.
• Sterilization method and packaging being the same as predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study design details for AI/ML, sample sizes, expert qualifications, or ground truth establishment. These concepts are not applicable to the context of this 510(k) submission.

Ask a specific question about this device