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K Number
K960404
Device Name
SURESKIN THIN
Manufacturer
EUROMED A/S
Date Cleared
1996-03-01

(32 days)

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

indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions.

Device Description

The SureSkin® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane film backing.

AI/ML Overview

The provided text describes a 510(k) summary for the SureSkin® THIN Hydrocolloid Wound Dressing, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study that establishes performance against specific acceptance criteria in the way you might expect for an AI/software as a medical device (SaMD).

Therefore, the information you're asking for (acceptance criteria, device performance table, sample sizes, expert involvement, MRMC study, standalone performance, ground truth, training set details) is not present in the provided 510(k) summary.

Here's why and what can be inferred:

  • Type of Device: The SureSkin® THIN Hydrocolloid Wound Dressing is a physical medical device (wound dressing), not a software/AI device.
  • Regulatory Pathway: The 510(k) pathway for this type of device primarily relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by comparing design, function, materials, and intended use, and confirming biocompatibility.
  • Lack of Performance Study Data (as requested): A 510(k) for a basic physical device like a wound dressing typically does not include the kind of detailed performance study data (sensitivity, specificity, AUC, etc.) that would be required for a diagnostic AI algorithm or a complex new medical treatment. The "performance" is generally demonstrated through the equivalence to the predicate and biocompatibility.
  • "Acceptance Criteria" and "Reported Device Performance": For this device, the "acceptance criteria" for regulatory clearance are more about demonstrating physical and chemical properties, biocompatibility, and equivalence to a predicate. The "reported device performance" would be that it functions as a wound dressing, but without specific metrics like sensitivity or AUC.
  • Biocompatibility Testing: The document mentions "Biocompatibility testing was performed on the device material in conformance with Tripartite and ISO 10993 recommendations. Results of all biocompatibility tests demonstrated that the device is suitable for its intended use." This is the primary "study" mentioned, but it focuses on safety (tissue interaction), not diagnostic accuracy or clinical effectiveness in a quantifiable way like an AI algorithm would.

In summary, none of the specific points you've asked for regarding acceptance criteria, performance tables, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies are applicable or reported in this 510(k) summary because it pertains to a physical wound dressing using a substantial equivalence pathway, not an AI/SaMD.

N/A