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Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories 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 Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liquid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.

The Smith & Nephew Images Digital 3-Chip Color Video Camera and Video components mate with the endoscope to allow for visualization during various surgical procedures. Smith & Nephew Images Illuminators, Light Guides and accessories are designed to supply light to the surgical site through the endoscope. The light guides mate to the endoscope and light source with instrument specific adapters.

The provided text is a 510(k) summary for the "Smith & Nephew Images Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories". This document focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a study with outcome metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove the device meets those criteria.

Key reasons for this conclusion are:

• Substantial Equivalence Focus: The document repeatedly emphasizes that the device is "substantially equivalent in both design and intended use" to existing predicate devices (Snowden Pencer DSP, Stryker Endoscopy, and Olympus). This means the focus is on demonstrating that the new device is as safe and effective as devices already on the market, not on proving it meets new, specific performance benchmarks.
• Lack of Performance Metrics: There are no reported performance metrics (e.g., resolution, light output, color accuracy, signal-to-noise ratio) for the Smith & Nephew device.
• Absence of Study Design: The document does not describe any study, test set, training set, ground truth establishment, expert adjudication, or MRMC studies. It mentions compliance with electrical safety standards (UL544, EN 55011, IEC 601-1, IEC 601-2-18) but these are general safety certifications, not performance studies with specific acceptance criteria as you've defined.

In summary, this 510(k) submission is a regulatory filing demonstrating equivalence, not a scientific study report with performance acceptance criteria.

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