Search Results

BioForm's Juliesse is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. Juliesse is a temporary implant and resorbs within a period of 3-6 months.

Juliesse is a sterile, non-pyrogenic iniectable material consisting of an aqueous formulation of USP grade pharmaceutical excipients consisting of sterile water, glycerin, sodium carboxymethylcellulose and phosphate buffer.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, or a study that proves the device meets specific acceptance criteria using a test set.

The document is a 510(k) summary for Juliesse™ Injectable Laryngeal Augmentation Implant, primarily focusing on its substantial equivalence to a predicate device and its pre-clinical safety evaluations. It states that "the battery of preclinical safety studies and animal implant studies show that the Juliesse™ Injectable Laryngeal Augmentation Implant is biocompatible when injected into soft tissues" and that "In vivo and In vitro tests were performed to address irritation, sensitization, cytotoxicity, acute and sub-chronic toxicity, genotoxicity and hemolysis. Results identified the Juliesse™ Injectable Laryngeal Augmentation Implant as a nonirritant, and nontoxic with no concerns for long-term safety." However, these are general summaries of pre-clinical tests and do not provide the detailed information requested regarding specific acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods for establishing ground truth.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt.

Ask a specific question about this device