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The Nisus ONE Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device allows wound management.

The Nisus ONE Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004)

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

Cork Medical has developed a negative pressure wound therapy (NPWT) system with the same intended use as the predicate device (K140022). The subject device features a modified user interface, and an adjusted feature set intended to support ease of use, while maintaining the same fundamental therapeutic function and performance characteristics as the predicate device. The Nisus ONE Negative Pressure Wound Therapy System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes.

The device display is limited to presenting critical operational parameters, including therapy mode, battery status, and target pressure settings. Visual and audible alarms are consistent with the predicate device (K140022) and alert critical battery, pressure leakage, system blockage, and full canister occur. While the Nisus ONE NPWT System's interface differentiates from the predicate Cork NPWT system, the mechanical components and therapy application are identical. The new model is intended to enhance accessibility by aligning with the needs of a broad and diverse patient population across various care settings.

The components included within the Nisus ONE NPWT System are:

• Nisus ONE Negative Pressure Wound Therapy Pump (OCMPP-100)
• Nisus ONE Pump Battery Charger (NIS-CHRG-A-18)
• Nisus NPWT Canister 500-mL (CPC-500)
• Nisus NPWT Canister 250-mL (CPC-250, previously cleared in K140022)

Accessory components are required to operate the device. Injection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The Nisus NPWT Canister 250-mL design was previously cleared in the Nisus NPWT system 510k application (K140022). The Nisus NPWT Canister 500-mL is based on the same design as the Nisus NPWT Canister 250-mL. The dimensions were enlarged to provide a larger reservoir for patient convenience. Thus, the subject and predicate canisters have substantially equivalent characteristics.

The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. Integrated with the pump mechanism, these components ensure the safe and efficient removal of wound exudate. NPWT Accessories were previously cleared in K132004. Our application for the Nisus ONE NPWT system includes no revisions to these previously cleared components.

The provided FDA 510(k) clearance letter for the Nisus ONE Negative Pressure Wound Therapy System does not contain information related to an AI/ML-based device performance study.

The document details the substantial equivalence of the Nisus ONE system to a predicate device, focusing on changes to the user interface, physical dimensions, and technical specifications of a powered suction pump. The "Nonclinical Tests" section describes bench performance testing of the pump's functionality (e.g., pressure, alarms, flow rate) using simulated wound exudate and a test bed fixture, as well as software verification and validation, electrical safety, EMC, and usability testing. These are standard engineering and regulatory tests for medical devices, not performance studies of an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample size, data provenance, expert qualifications, and adjudication methods for a test set related to an AI/ML algorithm.
• Details on MRMC studies or standalone AI performance.
• Information on training set size or ground truth establishment for an AI/ML algorithm.

The document explicitly states: "No Clinical Testing was required to support these 510(k) submissions. No clinical testing has been performed." This further indicates that no studies involving human data or expert review for AI/ML performance were conducted or reported in this submission.

If you have a document describing an AI/ML device, please provide that, and I would be happy to analyze it according to your criteria.

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