(287 days)
Under the management of a healthcare professional, Protego Antimicrobial Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, partial and full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions.
Protego Antimicrobial Wound Dressing is a sterile, single-use, non-adherent gauze dressing impregnated with an odorless petrolatum-based emulsion. The impregnated gauze is placed in a sealed pouch. The product contains Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK) to prevent microbial colonization within the dressing. Protego Antimicrobial Wound Dressing is intended to maintain a moist environment that is conducive to healing. Protego Antimicrobial Wound Dressingis packaged in single-use, LDPE tear pouches. Protego Antimicrobial Wound Dressing comes in three sizes, including 4"x 4," 1"x 8," and 2"x 2," with no differencein materials among the different sizes.
This document is a 510(k) premarket notification for a medical device, specifically a wound dressing. It outlines the regulatory clearance for the Protego Antimicrobial Wound Dressing. However, it does not contain any information about the acceptance criteria or a study that proves the device meets those criteria, as typically described for software or AI/ML-based medical devices.
The document focuses on demonstrating substantial equivalence to a predicate device (PolyPlex Wound Dressing, K160872) based on the device's physical properties, chemical composition, indications for use, and basic in vitro performance.
Therefore, I cannot provide the requested information from the provided text. The document does not discuss:
- A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven outcome.
- Sample sizes for test sets, data provenance, or retrospective/prospective study design.
- Number of experts, their qualifications, or ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
- Standalone algorithm performance.
- Types of ground truth (expert consensus, pathology, outcomes data).
- Training set sample size or how its ground truth was established.
This is a traditional medical device clearance document for a physical product (a wound dressing) that does not involve AI or complex diagnostic performance evaluation as would be seen for imaging software or AI-powered diagnostics. The "Performance Testing" section only mentions "Results of in vitro testing indicate that Protego Antimicrobial Wound Dressing effectively inhibits the growth of microorganisms within the dressing for up to 24 hours. The product is non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993 biocompatibility trials." These are standard biocompatibility and antimicrobial efficacy tests for a physical wound dressing, not acceptance criteria for an AI/ML device.
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