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The VERSA Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

The VERSA Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) and the VERSA NPWT 100ml Canister.

The VERSA Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment.

The Cork Medical VERSA Negative Pressure Wound Therapy System is designed to provide gentle powered suction to treat and promote wound healing by aiding in the removal of excess exudates, infectious material, and tissue debris. The single button design makes applying negative pressure wound therapy for patients and physicians without compromising the power and performance demanded for wound management.

The VERSA NPWT System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes. One button power on and off the pump and the other button switches pressure settings from 75 mm/Hg and 125 mm/Hg continuous and a 10 second hold on this button switches the pump to a variable intermittent mode, unlike its predecessor Cork NPWT System which uses multiple buttons and menus to adjust settings.

The VERSA NPWT System includes a therapy pump, 100 ml collection disposable canister, and carrying bag. The VERSA NPWT System is only intended to be used with the Cork NPWT Wound Dressing Kit.

The provided document is a 510(k) premarket notification for a medical device, the VERSA Negative Pressure Wound Therapy System (VCMPP-100). This submission is for a modification to an already cleared device (predicate device K230677), specifically to allow for home use and to implement a firmware update.

Based on the provided text, the device in question (VERSA Negative Pressure Wound Therapy System) is not an AI/ML device. The document describes a powered suction pump used for wound healing and does not mention any artificial intelligence or machine learning components. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them (including elements like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, etc.) cannot be extracted from this document as it pertains to an entirely different type of medical device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a change in environment of use and a minor firmware update. The "Nonclinical Tests" section details a series of bench performance tests for alarm functions and usability testing, which are standard for traditional medical devices, not AI/ML systems.

Therefore, I am unable to provide a response that directly addresses the specific requirements for an AI/ML device's acceptance criteria and study, as the provided input does not describe such a device or its evaluation.

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