(143 days)
Each Pillar Malar Implant is indicated for the augmentation or reconstruction of malar eminence deficiencies, whether congenital or acquired by trauma or disease.
The Pillar Malar Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.
I’m sorry, but this document does not contain the information you requested about acceptance criteria and device performance studies. The document is a 510(k) summary and FDA clearance letter for a malar implant, focusing on substantial equivalence to a predicate device, intended use, labeling, and physical/chemical properties. It does not include details on clinical studies, performance metrics, or ground truth establishment.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.