(95 days)
NovaBone MacroPor-Si*- Bioactive Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroPor-Sit is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities 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 and is replaced with bone during the healing process.
NovaBone MacroPor-Sit is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
NovaBone MacroPor-Si* is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. The mixed device is supplied sterile, packaged in a PET-G tray and outer peel pouch. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process.
The provided text describes a 510(k) submission for a medical device called NovaBone MacroPor-Si* - Bioactive Bone Graft. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a clinical study with acceptance criteria.
Therefore, the input does not contain the information needed to fill out sections 1-9 of your request, such as a table of acceptance criteria, device performance, sample size, expert qualifications, adjudication methods, or MRMC studies.
The document indicates that "In vivo performance data are presented in support of the new device," but the details of this data, including any acceptance criteria or the study design, are not provided in the excerpt. The focus of the provided text is on the device description, intended use, and substantial equivalence to legally marketed predicate devices based on technological characteristics and biocompatibility.
Based on the provided information, I cannot fulfill the request as it pertains to acceptance criteria and a study that proves the device meets those criteria. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to existing devices rather than new performance-based acceptance criteria and detailed clinical study results.
§ 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.