Search Results

The UNISURGE Interface Controller - P is indicated for use in procedures (endo in which the UNIGRIP is used... The Interface Controller with pump is not designed to deliver any type of blood, blood products, or analgesics. It is designed for the administration of sterile irrigation fluid via sterile deposable tubing

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 any specific acceptance criteria. The document is a clearance letter from the FDA regarding a 510(k) submission for the "Unisurge Interface P" device, stating that it is substantially equivalent to legally marketed predicate devices.

The text does include:

• Device Name: Unisurge Interface P (also referred to as UNISURGE Interface Controller - P)
• Indications For Use: "The UNISURGE Interface Controller - P is indicated for use in procedures (endo) in which the UNIGRIP is used..." and "The Interface Controller with pump is not designed to deliver any type of blood, blood products, or analgesics. It is designed for the administration of sterile irrigation fluid via sterile deposable tubing."
• Regulatory Class: II
• Product Code: GCJ
• 510(k) Number: K972178

However, it does not contain any details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any tests.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

This document is solely an FDA clearance letter confirming substantial equivalence, not a study report.

Ask a specific question about this device