(199 days)
The DRG Laryngeal Augmentation Implant Device is indicated for use in moreations for other inn for treatment of patients with unilateral vocal cord paralysis.
Laryngeal Augmentation Implant
I am sorry, but based on the provided document, there is no information about the acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, or any details related to AI/MRMC studies for the Laryngeal Augmentation Implant.
The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the regulation number, product code, and indications for use. However, it does not include the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth without further information.
§ 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.