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These devices are intended as a means of gaining access to the cerebral ventricles or cystic tumor for the short-term (less than 30 days) injection of chemotherapeutics agents and/or radioisotopes.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter for the "Phoenix Infusor Infusion Catheter System," indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The letter discusses:

• The device name (Phoenix Infusor Infusion Catheter System)
• Regulation number and name (21 CFR 882.5550, Central nervous system fluid shunt and components)
• Regulatory class (II)
• Product code (JXG)
• The date of the letter and previous correspondence
• Details about FDA regulations and responsibilities of the manufacturer
• The "Indications for Use" statement for the device, which specifies its intended purpose: "as a means of gaining access to the cerebral ventricles or cystic tumor for the short-term (less than 30 days) injection of chemotherapeutics agents and/or radioisotopes."

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds)
• Any study design
• Sample sizes for testing or training
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Types of ground truth
• How ground truth was established

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