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K Number
K133729
Device Name
WOUND DRESSING WITH MANUKA HONEY
Manufacturer
MANUKA HEALTH NEW ZEALAND LTD.
Date Cleared
2015-01-23

(413 days)

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

Wound Dressing with Manuka Honey is indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds and surgical wounds. For single-use only.

Wound Dressing with Manuka Honey is indicated for minor abrasions, minor scalds, and minor burns. For single-use only.

Device Description

Not Found

AI/ML Overview

I am sorry, but after carefully reviewing the provided document, I cannot find the specific information you requested regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a "Wound Dressing with Manuka Honey" and focuses on the device's substantial equivalence and indications for use.

It does not include details about:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes or data provenance for a test set.
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance studies.
  • Type of ground truth used.
  • Sample size for a training set.
  • How ground truth for a training set was established.

This type of information would typically be found in the premarket notification submission itself (the 510(k) summary or detailed reports), which is not part of the provided FDA letter.

N/A