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The InScope, LLC rotatable snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope .

The InScope, LLC rotatable snare consists of an actuation handle, rotation handle and snare loop. The loop is attached to the actuation handle by means of a cable. A monopolar electrical connector is provided on the handle and is electrically connected to the snare loop. The rotation handle is positioned on the snare shaft and provides rotation control of the snare loop to aid in orienting the loop with respect to the polyp. Figure 1, Typical Rotatable Snare, shows several views of the rotatable snare.

The InScope, LLC rotatable snares may be used with most monopolar electrosurgical generators. The rotatable snare has a universal connector which is compatible with both Microvasive and Olympus active cord connectors.

The provided text does not contain any information about acceptance criteria or a study proving device performance for the Rotatable Snare (K992477).

The document is a 510(k) summary for the InScope, LLC Rotatable Snare, which primarily focuses on:

• Identification of a legally marketed predicate device: The Microvasive Single-Use Polypectomy Snare (K950496).
• Device Description: Details on its components (actuation handle, rotation handle, snare loop, electrical connector) and compatibility with electrosurgical generators.
• FDA Clearance Letter: Confirming substantial equivalence to the predicate device and allowing marketing.
• Indications for Use: Electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.

Therefore, I cannot populate the requested tables and information as the source text does not provide it.

To answer your request, information regarding a scientific study demonstrating the device's performance against specific acceptance criteria would need to be present, which is not the case in this 510(k) summary. FDA 510(k) clearances often rely on demonstrating substantial equivalence to a predicate device, which may not always include a full-scale clinical trial with detailed performance metrics beyond what's available for the predicate.

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