(66 days)
EOVIA Calcium Phosphate Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. EOVIA Calcium Phosphate Ceramic is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. EOVIA Calcium Phosphate Ceramic provides a bone void filler that is resorbed and is replaced with bone during the healing process.
EOVIA is a synthetic, resorbable calcium phosphate bone void filler. It is an osteoconductive material, which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range between 200-500μm. EOVIA is available in granule or rods shapes.
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the EOVIA™ Calcium Phosphate Ceramic, detailing its description, intended use, materials, and a declaration of substantial equivalence to previously cleared devices.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample size, data provenance, expert qualifications, adjudication method, MRMC study details, standalone performance, ground truth type, or training set information.
§ 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.