(22 days)
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.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.