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The Veloxion System is intended for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

The Veloxion System consists of the following components:

• Veloxion Controller (with Integrated Fluid Control)
  • o Footswitch
• Veloxion Resecting Device Kit: ●
  • o Veloxion Resecting Device
  • o Sheath
  • 0 Continuous Flow Optical Obturator
• Veloxion Fluid Control Set ●
• Veloxion Saline Pole ●

The Controller provides bipolar radiofrequency outputs (cut and coagulation) and fluid control through the use of two integrated peristaltic pumps. The Resecting Device is a disposable, hand held bipolar radiofrequency device configured for the resection and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps, in conjunction with the disposable Fluid Control Set, which provides continuous inflow and aspiration during the procedure.

The provided text is a 510(k) premarket notification from the FDA, and it describes a medical device called the "Veloxion System" for endoscopically controlled tissue chip resection and coagulation, specifically for prostate adenomas.

However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, number of experts, ground truth, or MRMC studies) related to the clinical performance or efficacy of the device.

The "Performance Data" section (VII) lists various types of engineering and safety tests (e.g., Sterility, Biocompatibility, Software, EMC, Mechanical Integrity, Functional Testing, Dimensional Testing, Simulated Use, Thermal effect, Usability). These are primarily focused on the device's technical specifications, safety, and manufacturing quality, rather than its clinical efficacy or diagnostic accuracy.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document does not contain this type of information.

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