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Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.

Norian CRS Bone Cement is not intended for use in the spine and should not be used in the presence of active or suspected infection.

Norian CRS Bone Cement is an injectable, moldable, and biocompatible bone cement. The Reactants Pack contains sterile powder (calcium phosphate) and a syringe that contains sterile solution (dilute sodium phosphate). The Reactants Pack is designed to be placed in a reusable mixer where the 2 components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18 -23°C / 64°- 73°F. At body temperature (37°C / 98.6°F), Norian CRS Cement begins to harden after 2 minutes and sets in approximately 10 minutes. Norian CRS Cement is slowly resorbed and replaced by bone over a period of years. This material is provided sterile and is for single use only.

The provided document is a 510(k) summary for the Norian CRS Bone Cement. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, studies for device performance evaluation against such criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against acceptance criteria.

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