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The Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.

Additionally, the Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures in the thoracic cavitity when used in conjunction with an appropriately indicated thoracoscope.

The proposed Dyonics Vision 337 Autoclavable Camera Coupler can be used in conjunction with any direct-view endoscope or appropriate video-endoscope, control unit, light source, and monitor to allow illumination and visualization of articular cavities, body cavities, hollow cavities and canals. The camera head acts to transmits real time video images of the surgical site to the camera control unit. It then processes and displays the image to a viewing system or recording media.

The camera head attaches to the endoscope by means of a camera coupler.

The camera head and the camera coupler are hermetically sealed to allow for autoclavability.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is primarily a 510(k) premarket notification letter and summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..."
• "The proposed Dyonics Vision 337 Autoclavable Camera Coupler are substantially equivalent in design, materials of construction, and function and intended use as to the Smith & Nephew Images Digital 3-Chip Color Video Camera and Dyonics Camera Coupler."

This type of submission typically compares the new device to existing legally marketed predicate devices to show they are equally safe and effective, rather than conducting new performance studies against specific acceptance criteria for novel claims. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, and MRMC/standalone studies is not present in this document.

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