(29 days)
Norian® XR Calcium Phosphate Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian® XR Calcium Phosphate Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs over a period of years and is replaced with bone during the healing process.
Norian® XR, USP is an injectable, moldable, biocompatible bone void filler. The reactants pack contains sterile powder (calcium phosphate) with BaSO4 added for radiopacity and solution (dilute sodium phosphate). The Reactants Pack is designed to be placed in a reusable mixer where the components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18-23°C. Norian® XR begins to harden after 2 minutes and sets in approximately 10 minutes at body temperature (37°C). Norian® XR is slowly resorbed over a period of years. The 3cc, 5cc, 7.5cc, and 10cc Reactants Packs are provided sterile and are for single use only.
I am sorry, but the provided text focuses on the regulatory approval of a medical device (Norian® XR Calcium Phosphate Bone Void Filler) and does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) summary and approval letter from the FDA, which confirms the device's substantial equivalence to previously marketed devices. It does not detail specific performance metrics, clinical study designs with test sets, ground truth establishment, or expert evaluations.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.