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SureSkin Silver bandages are indicated for first aid to help minor cuts, scrapes, abrasions, lacerations, blisters and scalds.

SureSkin Silver bandages are sterile, single-use dressings that consist of silver -containing hydrocolloid adhesive bonded to an outer polyurethane film cover for an antimicrobial effect. The hydrocolloid adhesive is designed to interact with moisture from the skin and wound surface where it forms a gel and creates a moist wound environment that is known to speed the healing process faster than commonly used bandages Once the bandage begins to interact with moisture the silver in the adhesive is activated and helps to kill bacteria which are in direct contact with the dressing.

This is a 510(k) premarket notification for SureSkin Silver Bandage, which claims substantial equivalence to a predicate device. Therefore, a traditional acceptance criteria and study proving performance as one might expect for a novel device is not explicitly present in the provided document. The purpose of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device.

Instead of presenting an acceptance criteria table and a new clinical study to meet those criteria, the submission relies on demonstrating similarity to the predicate device and using non-clinical testing.

Here's a breakdown based on your request, focusing on what is provided and clarifying what is not:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not explicitly present in the 510(k) submission as it would be for a de novo device or a PMA application. For a 510(k), acceptance criteria are implicitly tied to demonstrating equivalence to the predicate device.

The document states: "Antimicrobial effectiveness and Microbial Barrier testing was performed on the predicate device and showed that it provides an effective microbial barrier in the dressing. Biocompatibility testing was performed. Test results demonstrated that the device is suitable for its intended use."

The current device, SureSkin Silver Bandage, is stated to be "identical in formulation, packaging materials and produced under same manufacturing processes to the predicate device." Therefore, the acceptance is based on the assumption that if the predicate device met these performance criteria, and the new device is identical, then the new device also meets them.

Summary of what's provided related to "performance":

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

• Test Set Sample Size: Not specified. This documentation refers to "in vitro laboratory testing" for antimicrobial effectiveness on the predicate device. The specific numbers of test samples, if any in a clinical sense, are not detailed as this is a non-clinical submission relying on equivalence for a Class I/unclassified device.
• Data Provenance: The "in vitro laboratory testing" was done on the predicate device. No geographical information is provided, but it would have been conducted by or for the manufacturer (EuroMed Inc.). The data is retrospective in the sense that it relies on past testing of a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable or provided in this 510(k) submission. No human clinical studies or expert-driven test sets (e.g., for image interpretation or diagnosis) are described. The evaluation relies on laboratory testing and comparison to an existing device.

4. Adjudication Method for the Test Set

This is not applicable or provided. There is no "test set" in the context of human-interpreted data or clinical outcomes requiring adjudication.

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

This is not applicable or provided. This type of study is relevant for diagnostic devices involving human interpretation of results, often with AI assistance. The SureSkin Silver Bandage is a wound dressing, not a diagnostic device.

6. Standalone (Algorithm Only) Performance

This is not applicable or provided. The device is a physical wound dressing, not an algorithm. The "antimicrobial effectiveness" can be considered a standalone performance characteristic of the dressing itself, but it's not an algorithm's performance.

7. Type of Ground Truth Used

For the in vitro antimicrobial effectiveness testing on the predicate device:

• Antimicrobial effectiveness: Likely based on standard microbiological methods (e.g., zone of inhibition, reduction in bacterial count) against specific bacterial strains (Staph aureus (MRSA), E. coli, and P. aeruginosa). The "ground truth" would be the measured reduction in bacterial growth or killing.
• Microbial Barrier: Likely based on physical testing demonstrating the dressing's ability to prevent microbial penetration.
• Biocompatibility: This would involve standard toxicology and irritation tests, with "ground truth" being the absence of adverse biological reactions.

8. Sample Size for the Training Set

This is not applicable or provided. There is no "training set" as this is not an AI/machine learning device.

9. How Ground Truth for the Training Set Was Established

This is not applicable or provided.

In summary: The provided document is a 510(k) premarket notification for a wound dressing. Its "acceptance criteria" are demonstrating substantial equivalence to a predicate device, which includes having similar performance characteristics as proven by in vitro laboratory testing on the predicate device and the new device being identical in composition and manufacturing. There are no clinical studies, expert-adjudicated test sets, or AI algorithm evaluations described in this type of submission.

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The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

The SureSkin III with Silver BORDER wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.

The SureSkin™ III with Silver THIN wound dressings are indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.

The SureSkin™ III with Silver wound dressings are also indicated for use on second degree burns and donor sites.

The SureSkin III with Silver Wound Dressings are identical to the SureSkin II products with the exception that the formulation has been slightly modified to include silver. The SureSkin III formulation includes the same well-known materials that are used in other hydrocolloid wound dressings. Polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing. The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.

This is a 510(k) premarket notification for a medical device (wound dressing), not an AI/ML powered device. As such, most of the requested information regarding AI/ML study design, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, is not applicable or not present in the provided document.

However, I can extract information related to the device's performance testing and acceptance criteria as described for this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable (N/A) for AI/ML powered device studies.
• For the performance testing mentioned (Antimicrobial effectiveness, Microbial Barrier, Biocompatibility), the document does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective). These are typically laboratory-based tests following specific protocols, not clinical studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A for AI/ML powered device studies.
• Ground truth as typically understood in AI/ML validation (e.g., expert consensus on image annotations) is not relevant here. The "ground truth" for this device's performance is established by the results of standardized laboratory tests and comparisons to predicate devices.

4. Adjudication method for the test set

• N/A for AI/ML powered device studies.
• Adjudication methods (like 2+1, 3+1) are common in clinical trials or expert review of AI outputs. This document describes laboratory testing; arbitration or adjudication of results would follow standard laboratory quality control and protocol adherence, not a multi-expert consensus process as implied by the question.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This is not an AI/ML powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. This is not an AI/ML powered device with an algorithm. Performance tests were done on the physical device itself.

7. The type of ground truth used

• For this device, the "ground truth" is established by:
  • Standardized Test Methods: Adherence to established USP methods for antimicrobial and microbial barrier testing.
  • International Standards: Compliance with International Organization for Standardization (ISO) recommendations for biocompatibility.
  • Predicate Device Comparison: Establishing substantial equivalence to previously cleared devices based on design, function, intended use, and material composition.

8. The sample size for the training set

• N/A for AI/ML powered device studies.
• There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established

• N/A for AI/ML powered device studies.
• There is no training set for this device.

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

The SureSkin™ II THIN hydrocolloid wound dressing is indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.

The SureSkin™ II dressings are also indicated for use on second degree burns and donor sites.

The SureSkin II wound dressings are identical to the SureSkin Plus products with the exception that the formulation has been slightly modified. The SureSkin II hydrocolloid wound dressing formulation includes the same well known materials w that are used in other hydrocolloid wound dressings.

The adhesive hydrocolloid surface of these wound dressings is in contact with the wound bed. Polyurethane foam (Standard) and polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (foam or film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing (Standard and Thin). The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.

The provided text (K992363) is a 510(k) summary for a medical device: SureSkin™ II Hydrocolloid Wound Dressings. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a novel study.

Therefore, the K992363 document does not contain the information requested regarding acceptance criteria and a study proving the device meets them because it's focused on demonstrating equivalence.

Here's why and what the document does state:

• No specific acceptance criteria: The document does not define numerical acceptance criteria for performance metrics (e.g., specific exudate absorption rates, wear time, healing percentages with a certain statistical significance).
• No dedicated performance study: The document does not describe a clinical trial or a detailed performance study designed to test the SureSkin™ II against acceptance criteria for efficacy or performance.
• Focus on Biocompatibility: The only "performance testing" mentioned is "Biocompatibility testing... in accordance with the International Organization for Standardization recommendations," which demonstrated the device is "suitable for its intended use." This is crucial for safety but not for proving comparative efficacy against specific clinical outcomes.
• Substantial Equivalence: The core of a 510(k) submission, as highlighted in the FDA's letter, is to show that the new device is "substantially equivalent" to legally marketed predicate devices. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.

In summary, based on the provided text, I cannot complete the requested tables and information because the document describes a 510(k) clearance process based on substantial equivalence, not a study designed to meet specific performance acceptance criteria.

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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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