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THE NORTECH FLUID CENTURION UNIT IS INDICATED FOR USE WHERE POST-OPERATIVE IRRIGATOIN IS INDICATED.

The Fluid Centurion is designed to be used where post-operative irrigation is required.
The Fluid Centurion is comprised of a battery operated, stand alone unit that is substantially equivalent in design, materials, and intended use to the Smith & Nephew Dyonics Levelert™ Fluid Level Sensor.

The provided document is a 510(k) submission, a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This type of document does not typically contain information about a dedicated study proving device performance against specific acceptance criteria in the way a clinical trial or algorithm validation study would.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting their device is similar enough to an already approved device in terms of intended use, technology, and safety/effectiveness that it doesn't require a new, extensive clinical trial.

Therefore, the specific information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document because it's not a study report. The document describes the device, its intended use, and argues for its substantial equivalence to an existing product, the Smith & Nephew Dyonics Levelert™ Fluid Level Sensor.

If this were a document describing an AI/ML device, the detailed information about acceptance criteria and studies would be crucial and would likely be found in a separate validation study report or in the detailed technical specifications accompanying the 510(k).

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