LogoFDA 510(k) Search
K Number
K093196
Device Name
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
Manufacturer
COUSIN BIOTECH S.A.S.
Date Cleared
2010-06-25

(259 days)

Product Code
FTL,OQL
Regulation Number
878.3300
Type
Abbreviated
Panel
SU
Reference & Predicate Devices
K072962,K021736
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

BIOMESH® CA.B.S.'Air® Composite is intended for use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.

Device Description

BIOMESH® CA.B.S.'Air® Composite medical devices are parietal prosthesis with inflatable expansion balloon and fixation threads.

AI/ML Overview

The provided text is a 510(k) summary for the BIOMESH® CA.B.S.'Air® Composite device. It states the purpose of the submission is to demonstrate substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or effectiveness studies (MRMC or standalone).

The relevant section, "Performance data," simply states: "BIOMESH® CA.B.S.'Air® Composite conforms to the special control 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh'." This indicates that the device met the general requirements for surgical mesh, but no specific performance metrics or studies are detailed in the provided text.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample sized used for the test set and the data provenance: This information is not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
  4. Adjudication method for the test set: This information is not present.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present, and the device described is a surgical mesh, not an AI diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present, and the device described is a surgical mesh, not an AI diagnostic tool.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
  8. The sample size for the training set: This information is not present.
  9. How the ground truth for the training set was established: This information is not present.

§ 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.