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The PROVOX Voice Rehabilitation System has exactly the same indications for use as the original PROVOX and is intended for use in prosthetic voice restoration after total laryngectomy. The prosthesis can be inserted at the time of laryngectomy (primary puncture), or at a later date (secondary puncture), or to replace another similar prosthesis.

The PROVOX Voice Rehabilitation System. Replacement is performed in an anterograde way, using the components accompanying the PROVOX2 device (Insertion tool). The development of an anterograde replacement method (through the tracheostoma) was a logical development since the retrograde replacement method (using a guide wire) is often discomfortable for the patient. The PROVOX2 can be used in primary or secondary TE-puncture procedures if it is used with the PROVOX GuideWire, the Trocar and Cannula, and the Pharynx Protector components of the PROVOX Voice Rehabilitation System.

The provided text is a 510(k) premarket notification letter from the FDA to Atos Medical regarding the Provox 2 Voice Prosthesis System. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the regulatory class and procode, and discusses general controls and regulations. The second page contains the "Indications for Use" for the Provox Voice Rehabilitation System.

Therefore, I cannot extract the requested information to fill in the table or answer the questions. The document you provided is a regulatory approval letter, not a clinical study report or a document detailing performance criteria and test results.

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