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ShiNeo Silicone Implant is intended for the augmentation of the nasal and/or chin contour

ShiNeo Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour.

ShiNeo Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The ShiNeo Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The ShiNeo Silicone Implant is individually packaged and sterilized by gamma radiation and is labeled for single use. ShiNeo Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.

This document is a 510(k) summary for the ShiNeo Silicone Implant. It asserts that the device is "identical/substantially equivalent" to a predicate device, the BioSiCar Silicone Implant (K193392).

Because the submission claims identity between the proposed device and the predicate device, it explicitly states:

• No performance data was submitted, and no new testing was provided.
• No acceptance criteria were established or studies conducted to demonstrate performance against such criteria for the ShiNeo Silicone Implant.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance simply does not exist within this 510(k) summary, as it wasn't required given the claim of identity. The regulatory strategy relies on showing the new device is the same as an already cleared device, not that it independently meets specific performance metrics through new testing.

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