Search Results

The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the CODAN IV Administration Set B400 Sp does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a clearance letter, confirming that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. It discusses:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls provisions and additional controls that may apply.
• Contact information for specific advice.
• Indications for Use: "The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) summary or other supporting documentation submitted to the FDA, but it is not present in the clearance letter provided.

Ask a specific question about this device