LogoFDA 510(k) Search
K Number
K061711
Device Name
OASIS WOUND MATRIX
Manufacturer
COOK BIOTECH, INC.
Date Cleared
2006-07-19

(30 days)

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

The Oasis® Wound Matrix device's intended use is for the management of wounds including:

  • . partial and full-thickness wounds,
  • pressure ulcers, .
  • . venous ulcers,
  • . diabetic ulcers,
  • . chronic vascular ulcers,
  • tunneled/undermined wounds, .
  • surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser . surgery, podiatric, wound dehiscence),
  • trauma wounds (abrasions, lacerations, second-degree burns, and skin . tears),
  • . draining wounds.
    The device is supplied sterile and is intended for one-time use.
Device Description

Animal-derived, extracellular matrix wound care product

AI/ML Overview

This document describes a 510(k) submission for the Oasis® Wound Matrix, a medical device for wound management. The information provided is primarily administrative and regulatory. It does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics.

Therefore, many of the requested details related to a performance study cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

  • Acceptance Criteria: Not explicitly stated in terms of performance criteria (e.g., healing rate, complication rate). The document mentions "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device." The approval is based on "substantial equivalence" to a predicate device, which implies that its intended use and safety/efficacy profile are similar, rather than meeting specific quantifiable performance targets.
  • Reported Device Performance: Not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • This information is not present in the provided text. The document is an FDA 510(k) summary and approval letter, not a clinical study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • This information is not present in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • This information is not present in the provided text.

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 device is not an AI-assisted diagnostic tool, but rather a wound matrix. Therefore, an MRMC study or AI-related performance metrics are not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

  • Not applicable as this is a wound matrix product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

  • This information is not present in the provided text. For a wound matrix, ground truth in a clinical study would typically involve wound closure rates, reduction in wound size, absence of infection, etc., but no such study details are included here.

8. The sample size for the training set

  • This information is not present in the provided text. This document does not describe a machine learning algorithm that would have a "training set."

9. How the ground truth for the training set was established

  • Not applicable for this type of device and submission.

N/A