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Atrium C-QUR Lite™ Mesh V-Patch is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

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The provided text is a 510(k) clearance letter from the FDA for the Atrium C-QUR Lite™ Mesh V-Patch. This document does not contain information regarding acceptance criteria, study details, or performance metrics typically found in a device's submission or clinical trial reports.

The letter primarily confirms that the FDA has reviewed the manufacturer's premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination allows the manufacturer to market the device, subject to general controls and other regulations.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

• Acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about test sets.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• Training set sample sizes or how ground truth for training was established.

This information would typically be found in the 510(k) submission itself, a summary of safety and effectiveness, or associated clinical study reports, none of which are present in the provided FDA clearance letter.

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