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Smith & Nephew Images Hysteroscopes and accessories are used to permit viewing of the cervial canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for endoscopic examination and treatment of the cerivcal canal and uterine cavity.

The Images Endoscopes and accessories transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a series of optical lenses and prisms. Hysteroscopic sheaths are used to access and maintain an opening into the uterus for introduction of the endoscope and surgical instruments. Sheaths also allow access for gas or liquid distention of the uterus. Semi-rigid and flexible manual instruments are utilized for examination and treatment of cervical and uterine tissues.

This document is a 510(k) summary for the "Smith & Nephew Images Endoscopes and Accessories for Use in Hysteroscopic Surgical Procedures" (K971188). It describes the device, its intended use, and its substantial equivalence to predicate devices.

Based on the provided text, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The 510(k) submission process focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than proving the de novo performance against a new set of acceptance criteria through a specific study.

Therefore, I cannot extract the requested information (points 1-9) because it is not present in the provided text. The document primarily establishes that the new device is "substantially equivalent in design, materials, function, and intended use" to existing, legally marketed devices.

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