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K Number
K092689
Device Name
MANUKAPLI WOUND DRESSING
Manufacturer
MANUKA MEDICAL LIMITED
Date Cleared
2010-05-20

(260 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K081584
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli Wound Dressings may be used Over-The-Counter for:

  • Minor Abrasions
  • Lacerations
  • Minor Cuts
  • Minor Scalds and Burns

Under the supervision of a healthcare professional, Manukapli Wound Dressings may be used for:

  • Leg Ulcers
  • Pressure Ulcers
  • 1st and 2nd Degree Burns (superficial and Partial Thickness)
  • Diabetic Foot Ulcers
  • Surgical Wounds
  • Traumatic Wounds
Device Description

Manukapli Wound Dressing consists of a sterile wound dressing designed to promote a moist wound healing environment. The device is constructed using medical grade Manukapli that is harvested and processed under controlled conditions. This Manukapli is sealed into polyethylene tubes before sterilization using gamma irradiation and is intended to be used by medical staff as part of a treatment program for patients with problematic wound care requirements. The device is provided sterile and is designed to be single used only. This is achieved by the tube design having a twist & shear off end cap that cannot be replaced.

AI/ML Overview

The provided text describes a medical device, Manukapli Wound Dressings, and the nonclinical testing performed to demonstrate its biocompatibility. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic accuracy, which is typically what "acceptance criteria" and "device performance" implies for AI/ML devices.

The information primarily focuses on:

  • Device Description: What the Manukapli Wound Dressing is.
  • Intended Use: The types of wounds it's designed to treat (e.g., minor abrasions, leg ulcers, burns).
  • Technology Comparison: Stating substantial equivalence to predicate devices based on function, composition, and intended use.
  • Nonclinical Testing (Biocompatibility): Tests performed to ensure the material is safe for contact with the human body.

There is no mention of an AI/ML component, diagnostic capabilities, or any performance metrics like sensitivity, specificity, AUC, or reader studies. Therefore, I cannot construct the requested table or answer the specific questions related to AI/ML device performance and ground truth establishment.

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

1. Table of acceptance criteria and the reported device performance

  • Acceptance Criteria: The document states, "The Manukapli Wound Dressings met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested." However, the specific numerical or qualitative criteria for these biocompatibility tests (e.g., "no cytotoxicity observed," "irritation score

N/A