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WoundPal is intended to be used as a primary dressing in the management of partial and full-thickness wounds, including diabetic ulcers, venous stasis ulcers, pressure ulcers, surgical wounds, ischemic ulcers, traumatic wounds, superficial burns, donor sites, and abrasions and lacerations.

The proposed WoundPal is a single use wound dressing consisting of a woven cotton gauze treated with an OTC antibiotic mixture composed of Polymyxin B Sulfate USP (10,000 units/gram) and Bacitracin Zinc USP (500 units/gram) in a hydrogel with 2% w/w lidocaine hydrochloride. Normal saline 0.9% is also added to maintain a moist dressing. A trace amount of oil of wintergreen is added as a fragrance. The product is intended as a primary dressing for use in the local management of painful skin wounds. The antibiotic mixture is present to help prevent bacterial contamination of the dressing. The dressing may be held in place with a variety of secondary dressings, including an additional bandage or with the addition of an outer layer comprised of a polymeric film that may be secured by applying zinc oxide ointment USP between the film and intact skin surrounding the wound.

The provided text is a 510(k) summary for the WoundPal Medicated Wound Dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided document.

The document primarily states:

• Device Description: A single-use wound dressing with an OTC antibiotic mixture (Polymyxin B Sulfate USP and Bacitracin Zinc USP), hydrogel with 2% w/w lidocaine hydrochloride, normal saline, and a trace of oil of wintergreen.
• Intended Use/Indications for Use: Primary dressing for partial and full-thickness wounds, including diabetic ulcers, venous stasis ulcers, pressure ulcers, surgical wounds, ischemic ulcers, traumatic wounds, superficial burns, donor sites, and abrasions and lacerations. It absorbs wound exudates and maintains a moist environment.
• Technological Characteristics: The device is considered equivalent to predicate devices as wound coverings/dressings, containing ingredients to prevent bacterial contamination, lidocaine for pain relief, and saline for moistening.
• Safety and Efficacy: The document explicitly states, "Because of the long history of safe use of the components of WoundPal independently, and in combination, the device does not raise any new safety issues and biocompatibility testing was not necessary." This indicates that a new performance study with specific acceptance criteria, as one might find for a novel device or software, was not deemed necessary for this 510(k) clearance based on the substantial equivalence pathway for a combination product of well-established components.

In summary, the provided text does not contain the information required to populate the requested table and answer the study-related questions. The 510(k) submission for WoundPal relied on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a new clinical performance study with acceptance criteria.

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