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K Number
K090909
Device Name
C-QUR V -PATCH MESH
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2009-06-04

(64 days)

Product Code
FTL
Regulation Number
878.3300
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Atrium C-QUR V-Patch™ Mesh 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.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a surgical mesh device, the "Atrium C-QUR V-Patch™ Mesh". It confirms that the device is substantially equivalent to legally marketed predicate devices.

This type of document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding artificial intelligence or device performance compared to specific metrics.

The 510(k) process for a Class II device like surgical mesh typically relies on demonstrating substantial equivalence to a predicate device through evidence such as:

  • Similar materials
  • Similar design
  • Similar manufacturing process
  • Similar intended use
  • Performance data (e.g., mechanical testing, biocompatibility in animal models) demonstrating the new device performs as safely and effectively as the predicate.

However, the provided text does not contain any of these specific study details or acceptance criteria tables. It is a regulatory clearance letter, not a study report or a summary of performance data.

Therefore, I cannot provide the requested information from the provided input regarding:

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

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.