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K Number
K090858
Device Name
PARIETEX MONOFILAMENT POLYESTER MESH
Manufacturer
SOFRADIM PRODUCTION
Date Cleared
2009-05-06

(37 days)

Product Code
FTL
Regulation Number
878.3300
Type
Traditional
Panel
SU
Reference & Predicate Devices
K081126
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Parietex™ Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.

Device Description

PARIETEX™ - Monofilament Polyester Mesh is made out of a non-absorbable bi-dimensional monofilament polyester knitting and is available in rectangular shape.

AI/ML Overview

This document is a 510(k) summary for a medical device called PARIETEX™ - Monofilament Polyester Mesh. It describes the device and its intended use, but it does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or AI performance.

The "Performance Data" section states: "Bench testing has been conducted to evaluate the performance characteristics of PARIETEX™ - Monofilament Polyester Mesh. Testing has shown that the PARIETEX™ - Monofilament Polyester Mesh is similar in performance characteristics to the predicate MERSILENE™."

This indicates a comparison was made to a predicate device, but it's focused on the material's performance characteristics through bench testing, not a study evaluating diagnostic accuracy or a specific set of acceptance criteria for an AI/algorithm-driven device.

Therefore, the requested information for an AI/algorithm-focused study cannot be extracted from this document.

Based on the provided document, the following cannot be answered:

  1. A table of acceptance criteria and the reported device performance: The document only mentions bench testing showing similarity in performance characteristics to a predicate device, but no specific quantitative acceptance criteria or reported values are given.
  2. Sample size used for the test set and the data provenance: Not applicable as there is no study described that involves a "test set" in the context of an algorithm.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this document pertains to a surgical mesh, not a diagnostic imaging or AI device.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
  9. How the ground truth for the training set was established: Not applicable.

§ 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.