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The CMOS Video Rhino-Laryngoscope SSU is intended to provide visualization of nasal lumens and airway anatomy (including nasopharynx and trachea) during diagnostic procedures.
The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

The CMOS Video Rhino-Laryngoscope SSU System includes three main components: (1) the CMOS Video Rhino-Laryngoscope SSU (091330-01), (2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video Rhino-Laryngoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Rhino-Laryngoscope SSU is provided sterile (EtO), for single use only.

The provided text describes the submission of a new medical device, the CMOS Video Rhino-Laryngoscope SSU, for 510(k) clearance by the FDA. However, the document does not contain information about acceptance criteria, device performance metrics, or study results that would typically prove a device meets specific performance criteria.

Instead, the document focuses on regulatory compliance and demonstrating substantial equivalence to predicate devices through non-clinical testing. It states:

• "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
• "The conclusions drawn from the nonclinical tests demonstrate that the subject device, the CMOS Video Rhino-Laryngoscope SSU is substantially equivalent to the predicate devices, that are currently marketed for the same intended use."

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the input text. The information is not present within this regulatory submission summary.

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