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Silver PU Antibacterial Foam Dressings are indicated for the management of light to moderate exuding partial and full thickness wounds, such as: '. - Decubitus (pressure) ulcers - Diabetic ulcers 0 - Leg ulcers . - Graft and donor sites - Lacerations and abrasions 9 - 1st and 2nd degree burns - Trauma wounds (dermal lesions, trauma injuries or incisions) e - Post-operative surgical wounds The Silver PU Antibacterial Foam Dressings are indicated for external use only

The Silver PU Antibacterial Foam Dressings is available in two variants: Silver PU Antimicrobial Foam Dressing - Non-Adherent variant consists of a low friction waterproof polyurethane film, which also provides a bacterial barrier, laminated to hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer. Silver PU Antimicrobial Foam Dressing - Island variant consists of a polyurethane waterproof membrane coated with pressure sensitive acrylic adhesive, which also provides a bacterial barrier, with a centrally located hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer. Each Silver PU Antibacterial Foam Dressing contains a minimum of 0.26mg/cm² of elemental silver, the antibacterial action of the silver protects the dressing from bacterial contamination and provides an effective barrier to bacterial penetration. The antibacterial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against a broad spectrum of microorganisms associated with wound infection, such as Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Strentococcus pvogenes, Enterococcus faecalis (VRE) and Escherichia coli. Silver Antibacterial Foam Dressings may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing. Silver PU Antibacterial Foam Dressings are soft, highly absorbent, conformable and create the ideal environment for moist wound healing. Silver PU Antibacterial Foam Dressings are suitable for use under compression bandaging. Silver PU Antibacterial Foam Dressings are available in various sizes and shapes. The dressings are packaged in individual pouches, then into shelf cartons.

The document describes a 510(k) submission for Silver PU Antibacterial Foam Dressings. The acceptance criteria and supporting studies are presented in the form of performance data demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "antimicrobial, animal and bench testing" but does not specify sample sizes for these tests. Data provenance for these tests is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for the data itself, beyond the manufacturing location of the applicant (United Kingdom) and the predicate device manufacturers (unspecified locations, but common for global medical device companies).

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

Not applicable. This submission focuses on the performance of a wound dressing, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set. The "ground truth" for this type of device lies in objective measurements from laboratory, animal, and bench testing.

4. Adjudication Method for the Test Set:

Not applicable. As above, this type of submission does not involve an adjudication method by human readers for a test set in the same way an AI diagnostic device would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. This type of study is typically performed for diagnostic devices where human reader performance is a key metric, often with and without AI assistance.

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

Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation is based on:

• In vitro microbiological testing: To demonstrate antibacterial efficacy against specific pathogens.
• Animal testing: Implies studies on living organisms, likely for biocompatibility, wound healing, or safety aspects. The specifics are not detailed.
• Bench testing: Involves laboratory tests to assess physical properties like absorption, integrity, silver release, and barrier functions.
• Biocompatibility testing: Performed according to BS EN ISO 10993-1 standards, which involves a series of tests to determine the biological response of the device material in contact with the body.
• Sterilization validation: To confirm the effectiveness of the sterilization process.

These types of ground truth are objective, measurable outcomes in a laboratory or controlled environment, rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a physical medical device (wound dressing), not an AI/machine learning model. Therefore, there is no "training set" in the context of AI.

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

Not applicable. As stated above, there is no training set for this type of device.

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