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510(k) Data Aggregation
(444 days)
DISPOSABLE 330PSI EXTENSION LINES
to be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.
Disposable, 330psi Extension Lines
This document is a 510(k) summary for a medical device (Disposable 330psi Extension Lines) and does not contain the type of acceptance criteria and study information requested. The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- Acceptance criteria or reported device performance in a table format.
- Sample sizes, data provenance, or details about test sets.
- The number or qualifications of experts, nor adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size or ground truth establishment for a training set.
This information would typically be found in a separate clinical or non-clinical study report submitted as part of the 510(k) premarket notification, not in the FDA's substantial equivalence determination letter.
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