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K Number
K972458
Device Name
LYOCELL WOUND DRESSING/SURGICAL SPONGE
Manufacturer
COURTAULDS FIBERS, INC.
Date Cleared
1997-09-19

(80 days)

Product Code
MGP,EFQ
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

LYOCELL Wound Dressing / Surgical Sponge is intended to be used for the local management of partial and full thickness wounds, including minor burns. LYOCELL is also intended to be used as a sponge for cleaning wounds and for absorbing excess body fluids or exudate. LYOCELL is also intended to be used to help control minor bleeding.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot describe the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the requested format.

The document is a 1997 FDA 510(k) clearance letter for the "LYOCELL Wound Dressing/Surgical Sponge." This type of document does not contain detailed information about specific performance studies, acceptance criteria, or the methodology of such studies.

Instead, a 510(k) clearance states that the device is "substantially equivalent" to predicate devices already on the market. This determination is based on a review of information provided by the manufacturer, which typically includes:

  • Indications for Use: What the device is intended to be used for.
  • Technological Characteristics: How the device works and its materials.
  • Performance Data: Often limited to bench testing or biocompatibility, and not presented with the level of detail requested for acceptance criteria and study design. Clinical trials, especially in 1997 for this type of device, would not always be required for a 510(k) unless there were new or significant safety/effectiveness concerns.

The document does not include any of the following information that you requested:

  • A table of acceptance criteria and reported device performance.
  • Sample size for a test set or data provenance.
  • Number and qualifications of experts for ground truth establishment.
  • Adjudication method.
  • Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Standalone (algorithm-only) performance.
  • Type of ground truth used (expert consensus, pathology, outcomes data).
  • Sample size for a training set.
  • How ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

N/A