LogoFDA 510(k) Search
K Number
K132397
Device Name
GORE BIO-A WOUND MATRIX
Manufacturer
W. L. GORE & ASSOCIATES, INC.
Date Cleared
2014-05-07

(279 days)

Product Code
QSZ,FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K021792,K022127,K090160,K083266
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The GORE® BIO-A® Wound Matrix is intended for use in the management of wounds.

Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mob's surgery, post laser surgery, podiatic, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds.

Device Description

GORE® BIO-A® Wound Matrix device is a tailorable, porous, bioabsorbable material matrix that provides a scaffold for cellular infiltration and vascularization. The device permits the ingress of cells and soft tissue formation into the defect space/wound bed. GORE® BIO-A® Wound Matrix is a porous fibrous structure composed solely of a synthetic copolymer comprised of polyglycolic acid and trimethylene carbonate (PGA:TMC).

AI/ML Overview

This document is a 510(k) Summary for the GORE® BIO-A® Wound Matrix. It does not describe an AI medical device or provide acceptance criteria and study data in the typical format for such a device.

Therefore, I cannot fulfill your request for an acceptance criteria table and study details as they pertain to an AI device. The document describes a traditional medical device (wound matrix) and its substantial equivalence to predicate devices based on pre-clinical (bench and animal) testing, not on AI algorithm performance.

Here's why the provided information doesn't fit the requested structure:

  • No AI Device: The device described is a biocompatible wound matrix, not an AI algorithm.
  • No "Acceptance Criteria" for AI Performance: The document discusses meeting "intended product specifications" and similarity to predicate devices, which are not the same as performance metrics like sensitivity, specificity, or AUC typically used for AI.
  • No "Study that Proves the Device Meets Acceptance Criteria" for AI: The "Performance Data" section details bench and animal studies (biocompatibility, wound closure, histological assessment) for the physical wound matrix, not studies evaluating an AI algorithm's diagnostic or predictive capabilities.
  • No "Test Set," "Training Set," "Ground Truth," "Experts," "MRMC Study," or "Standalone Performance" related to AI: These concepts are specific to AI/machine learning model evaluation and are not applicable to the GORE® BIO-A® Wound Matrix.

N/A