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Renasys™ -F NPWT Foam Dressing Kits are intended to be used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to the wound. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

NPWT is appropriate for use on the following wounds:

• Pressure ulcers
• · Diabetic/neuropathic ulcers
• · Venous insufficiency ulcers
• · Traumatic wounds
• · Post-operative and dehisced surgical wounds
• · Explored fistulas
• · Skin flaps and grafts

The NPWT Foam Dressing Kits are a line extension to Smith & Nephew's current Chariker-Jeter™ wound dressing kits. The foam kits are offered in four sizes: small, medium, large and extra-large. In addition to the foam wound dressing, the kits contain a drain and tube to connect to a waste canister and one or more transparent film drapes, depending on kit size. The kits are supplied sterile and are single-use.

The foam is a polyurethane material that is substantially equivalent to other foam dressings currently on the market. The drain and tube materials are silicone or PVC and the drapes are clear polyurethane film; all common materials currently found in similar wound care products.

The provided text is a 510(k) summary for NPWT Foam Dressing Kits. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or clinical effectiveness studies (MRMC or standalone AI performance).

The document is a regulatory submission demonstrating substantial equivalence to existing devices (Versatile 1 EZCare Wound Vacuum System 510(k) #K061919 and Antlia II™ Suction Pump System 510(k) #K070904). This type of submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device, rather than requiring new clinical performance studies with specific acceptance criteria and detailed study designs.

Therefore, I cannot provide the requested information from the given text.

To address your request, I would need a document that describes:

• Specific performance metrics (e.g., sensitivity, specificity, accuracy, wound healing rates, pressure maintenance)
• Pre-defined thresholds for these metrics (acceptance criteria)
• The design and results of a study (clinical trial, bench testing, etc.) that evaluated the device against these criteria.

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