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The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers.

The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers. The devices were originally cleared for marketing under K960393-SureSkin™ BORDER Dressing, K960394-SureSkin™ STANDARD Dressing, and K960404-SureSkin™ THIN Dressing. The only purpose of the current 510(k) premarket notification for these products is to update the device labeling to be consistent with equivalent products. The three dressings will be contraindicated for use on 3rd degree burns. No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission.

This document is a 510(k) summary for a labeling revision of SureSkin™ Hydrocolloid Wound Dressings. It explicitly states that "No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission."

Therefore, based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria for the current submission. The submission focuses solely on updating device labeling, specifically contraindicating the dressings for 3rd-degree burns.

Consequently, I cannot provide the requested information in the table or answer questions 2 through 9, as they pertain to performance studies that were not conducted or included in this specific 510(k) submission.

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The SureSkin® STANDARD Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of light to heavy exudating pressure sores and leg ulcers.

The SureSkin® STANDARD Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of light to heavy exudating pressure sores and leg ulcers. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing.

The provided 510(k) summary for the SureSkin® STANDARD Hydrocolloid Wound Dressing does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth methodologies.

The document primarily focuses on:

• Administrative details: Date prepared, submitter, contact, device name, and classification.
• Device description: Stating its composition (hydrocolloid and polyurethane backing), intended use (management of light to heavy exudating pressure sores and leg ulcers), and comparison to a predicate device (DuoDerm Dressing).
• Substantial Equivalence claim: This equivalence is based on descriptive information (design, materials, intended use) and biocompatibility testing.

There is no mention of:

• Specific acceptance criteria for device performance.
• A study comparing the device's performance against defined criteria.
• Sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or human-AI interaction.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size or ground truth establishment for a training set.

The statement "Results of all biocompatibility tests demonstrated that the device is suitable for its intended use" indicates that some testing was performed, but it only addresses biocompatibility, not the clinical efficacy or functional performance metrics that would typically be associated with acceptance criteria for device performance in managing wounds.

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

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.

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.

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The SureSkin® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily exudating pressure sores and leg ulcers.

The SureSkin® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily exudating pressure sores and leg ulcers. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing. The dressing is similar in design, function, materials, and intended use to other hydrocolloid/occlusive dressings currently in commercial distribution, e.g., DuoDerm Dressing marketed by Convatec.

The provided text describes a 510(k) Summary for the SureSkin® BORDER Hydrocolloid Wound Dressing. It details the device's description, classification, and comparison to predicate devices, focusing on its design, materials, and intended use for wound management. The document also mentions biocompatibility testing.

However, the text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It lacks the specific details requested in the prompt, such as performance metrics, sample sizes for test or training sets, expert involvement, or statistical analysis.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and a detailed study based solely on the provided input. The document focuses on regulatory submission information rather than a performance study report.

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