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Vocalis and Vocalis SM are indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication. The product is intended to be durable for a period of one month.

Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principle durable component is synthetic calcium hydroxylapatite. The semi-sold nature is created by suspending the calcium hydroxylapatite particles in a durable high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the Carbopol 974P NF (USP).

The provided text is a 510(k) summary for the Vocalis and Vocalis SM vocal fold implants. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on:

• Intended Use: Vocal fold medialization and vocal fold insufficiency to improve phonation, with a durability of one month.
• Product Description: Sterile, latex-free, non-pyrogenic, semi-solid, cohesive subdermal implant with synthetic calcium hydroxylapatite suspended in a thixotropic gel.
• Substantial Equivalence: Lists several predicate devices (K013243, K070090, K071663, K080956).
• Pre-Clinical Tests: Biocompatibility, sterilization, and general in vivo/in vitro tests for irritation, sensitization, cytotoxicity, toxicity, genotoxicity, and hemolysis. These tests concluded the device is non-irritant, non-toxic, and has no long-term safety concerns.
• Risk Assessment: Identified primary risks associated with nasopharyngoscopy and injection laryngoplasty.
• Summary: Concludes the device is safe and effective as a space-filling material for soft tissue augmentation in laryngeal procedures.

Therefore, I cannot extract the requested information, as the document does not contain details about acceptance criteria, specific performance studies with sample sizes, expert involvement, or ground truth establishment for clinical effectiveness. The review is a premarket notification centered on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.

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