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The Provox® Vega Voice Prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is handled by the Patient while it remains in situ.

The Provox SmartInserter is a sterile single use device intended for anterograde replacement of the Provox Vega Voice Prosthesis. This replacement procedure is carried out by a medical doctor or a trained medical professional in accordance with local or national guidelines.

The Provox SmartInserter is not intended to be used for insertion of a voice prosthesis in a freshly made puncture.

Environments of use for the Provox® Vega. Voice Prosthesis include - hospitals, subacute care institutions and home.

For the Provox SmartInserter environments of use include - hospitals and sub-acute care institutions.

The Provox Vega is a one-way valve (prosthesis) that keeps a TE-puncture open for speech, while reducing the risk of fluids and food entering the trachea. The Provox Vega voice prosthesis is not a permanent implant, and needs periodic replacement. The prosthesis is available in different diameters and several lengths. The device is made of silicone and fluoroplastic.

The Provox Vega package contains the following items:

• · 1 Provox Vega voice prosthesis pre-loaded in a single-use SmartInserter, sterile
• · 1 Provox Brush of a size corresponding to the voice prosthesis, non-sterile
• · 1 Clinician Manual
• · 1 Patient Manual
• · 1 Provox Brush Instructions for Use

The provided text describes the Provox® Vega™ voice prosthesis but does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. This document is a 510(k) summary for a medical device, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance criteria and the results of a specific clinical study against those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document mentions that there are "no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices," which is the basis for its substantial equivalence determination, but it does not report on specific performance metrics or trials against predefined acceptance criteria for the Provox® Vega™ itself.

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