Search Results

Each Pillar Chin Implant is indicated for the augmentation or reconstruction of facial chin deformities, congenital or acquired by trauma or disease.

The Pillar Chin Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. 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.

The provided text is a 510(k) summary for a chin implant, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of device performance against specific acceptance criteria.

Therefore, the document does not contain the information requested to complete the table and answer the questions regarding acceptance criteria, device performance, study details, ground truth, or sample sizes for a scientific study.

The primary claims for the Pillar Chin Implant are:

• Substantial Equivalence: It is substantially equivalent to the Silimed Chin Implants.
• Material Equivalence: Made from identical liquid elastomer materials and manufacturing processes as the predicate device.
• Intended Use Equivalence: Intended to augment or reconstruct facial chin deformities caused by facial trauma or congenital defects, and implanted using the same accepted surgical methods of the predicate device.
• Physical/Chemical Properties Equivalence: Physical properties are the same as the predicate device, using equivalent materials (Nusil's MED 4211 unrestricted silicone fluid). Durometer (shore A) ranges from 5 to 30, appearance is clear to opaque, tensile strength averages 700 psi, and percent elongation is over 400 percent. Raw materials are certified and tested to comply with manufacturer requirements.

Ask a specific question about this device