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Prescription Use:
Under the supervision of a healthcare professional, the Antimicrobial Gelling Fiber Dressing with PHMB is indicated for the management of:

• · Post-surgical incisions
• Pressure ulcers
• · Diabetic ulcers
• · Venous stasis ulcers
• · Donor sites
• · Abrasions
• · Lacerations
• · Superficial and Partial thickness burns
• · Dermatologic disorders
• · Other wounds inflicted by trauma
  Over-the-Counter Use:
  The Antimicrobial Gelling Fiber Dressing with PHMB may be used for the management of:
• · Minor abrasions
• · Minor lacerations
• Minor cuts
• Minor scalds and bums

Antimicrobial Gelling Fiber Dressing with PHMB, is a sterile, non-woven pad or rope composed of carboxymethylcellulose (CMC) fibers, Polyhexamethylene Biguanide (PHMB), Ethylenediaminetetraacetic acid (EDTA), and a reinforcement layer (nylon) for intact removal. The dressing is soft, conformable, and highly absorbent, making it ideal for use with moderate to heavily exuding chronic and acute wounds. As wound exudate containing microorganisms is absorbed and trapped within the dressing, a gel is formed that conforms to the wound bed and anatomical contours, and aids in maintaining a moist wound environment and removing non-viable tissue and slough (autolytic debridement). This is conducive to the natural healing process.
The dressing contains an active ingredient, PHMB. Based on in vitro performance data, the Antimicrobial Gelling Fiber Dressing with PHMB effectively reduces microbial colonization within the dressing for up to 7 days.
The device is presented in a range of both flat/pad (160 g/m 2 and 200 g/m 2 ) and rope (160 g/m 2 ) dressings. The dressings are manufactured consistently using the same raw materials, the same manufacturing lines, follow a similar manufacturing process and utilize the same sterilization route. The sterile dressings are supplied in a range of sizes between 4in 2 (25cm 2 ) to 96in 2 (600cm 2 ).

This document describes a 510(k) premarket notification for a medical device called "Antimicrobial Gelling Fiber Dressing with PHMB." It asserts substantial equivalence to predicate devices, but does not contain information related to software, algorithms, AI performance, or specific acceptance criteria for such a system.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document details the device's physical properties, indications for use, and a summary of performance testing, which are primarily related to physical characteristics, sterility, biocompatibility, and antimicrobial efficacy of the dressing itself.

Here's the relevant information that is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Performance Testing Summary" but doesn't explicitly list specific acceptance criteria values alongside device performance values in a table format as might be expected for an AI/software device. Instead, it describes general categories of testing and general statements of efficacy.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a study involving a test set for an AI/algorithm. The performance testing is for the physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving human experts establishing ground truth for an AI/algorithm test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device is a physical wound dressing and does not involve human readers or AI assistance in an interpretive capacity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/algorithm. For the physical device, efficacy against microorganisms was demonstrated in vitro.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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