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The SureSkin™ Plus STANDARD and SureSkin™ Plus BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.

The SureSkin™ Plus THIN hydrocolloid wound dressing is indicated for the management of dry to lightly exudating wounds, such as pressure sores and leg ulcers.

The SureSkin™ Plus dressings are also indicated for use on superficial wounds and abrasions. second degree burns, and donor sites.

The new SureSkin™ Plus Standard, SureSkin™ Plus Border, and SureSkin™ Plus Thin hydrocolloid wound dressings are identical to the predicate SureSkin™ products except for a slight change in the hydrocolloid materials. The materials are the same except that mineral oil has been added and gelatin has been omitted from the hydrocolloid.

The SureSkin® Plus Hydrocolloid Wound Dressings manufactured by Euromed, Inc. are wound dressings composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing. The dressing is identical in design, function and intended use to the commercially available predicate SureSkin™ wound dressings. The only difference is the slight change in formulation of the materials.

The provided 510(k) summary for SureSkin™ Plus Hydrocolloid Wound Dressings does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way a diagnostic or AI-driven device would.

This submission is for a medical device (wound dressing) where the primary focus is demonstrating substantial equivalence to existing predicate devices, rather than meeting specific performance thresholds through a clinical study with detailed statistical endpoints.

Here's a breakdown of why the requested information is absent and what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable in this context. For devices like wound dressings, acceptance criteria typically relate to material properties, strength, sterility, biocompatibility, and intended use equivalence, rather than specific numerical diagnostic performance metrics (e.g., sensitivity, specificity).
• The document states: "Results of the biocompatibility tests demonstrate that the device is suitable for its intended use." This is a general statement of compliance, not a report of specific numerical performance against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. There is no "test set" in the context of diagnostic performance as described in the prompt. The "testing" referred to is biocompatibility testing of the materials themselves, governed by ISO recommendations. The document does not specify sample sizes for these tests, nor data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. "Ground truth" as defined in the prompt (expert consensus, pathology, outcomes data) is relevant for diagnostic performance studies. For this wound dressing, the "truth" is established through
  • Material composition: The key change is the addition of mineral oil and omission of gelatin, which constitutes the primary difference from predicate devices.
  • Biocompatibility testing: This confirms the new material is safe for contact with human tissue.
  • Comparison to predicate devices: The "truth" of its efficacy and safety stems from the established history of the predicate devices.

4. Adjudication Method:

• Not Applicable. No ground truth establishment or diagnostic performance evaluation requiring adjudication occurred.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study (comparing human readers with and without AI assistance) is specifically for evaluating diagnostic AI systems, which this device is not.

6. Standalone Performance Study (Algorithm Only):

• No. This is also relevant for AI/diagnostic algorithms, not for a wound dressing.

7. Type of Ground Truth Used:

• Not Applicable for diagnostic performance. The "ground truth" for this device revolves around its material science properties and biocompatibility as per ISO standards, and its functional equivalence to predicate devices (K960393, K960394, K960404, K863390, K853844).

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable.

Summary of available information from the document related to "acceptance" and "proof":

• Acceptance Criteria (Implied): The device must be "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness.
  • Key implied criteria:
    • Biocompatibility: Meet ISO recommendations.
    • Material change: The new formulation (addition of mineral oil, omission of gelatin) must not negatively impact safety or effectiveness compared to the previous formulation.
    • Intended Use: Match the predicate devices.
    • Design & Function: Identical to predicate devices.
• Study Proving Acceptance (Method):
  • "Performance Testing" refers to Biocompatibility testing. The document states: "Biocompatibility testing was performed in accordance with the International Organization for Standardization recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use."
  • Comparison to Predicate Devices: The core of the 510(k) submission is to demonstrate that despite the material change, the device remains "identical in design, function and intended use to the commercially available predicate SureSkin™ wound dressings." This comparison itself is the "proof" of meeting the acceptance criteria of substantial equivalence.

In essence, this 510(k) relies on the established safety and efficacy of predicate devices and confirms that minor material changes do not alter that status, backed by general biocompatibility testing. It is not a performance study in the way one would evaluate a new diagnostic tool.

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