(262 days)
NovaBone Putty - Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty 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 Putty is a two-component resorbable bone void filler composed of a synthetic bioactive glass particulate mixed with a binder. The major component is melt-derived calcium-phosphorus-sodium-silicate (Bioglass) particulate a designed specifically for its absorbability and osteoconductive nature. The second component is gelatin powder, selected for its biocompatibility and physical gelation properties to act as a temporary binding agent for the particulate. The gelatin is rapidly absorbed from the graft site to permit tissue infiltration between the Bioglass particles and replacement of the particles by host bone during the healing process.
The provided text describes NovaBone Putty, a resorbable bone void filler, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, a specific study proving device performance against such criteria, associated statistical metrics, or details typically found in a clinical study report or performance evaluation report for an AI/ML device.
The document is a 510(k) summary for a medical device (bone void filler) and focuses on describing the device, its intended use, technological characteristics compared to predicates, warnings, and complications to demonstrate substantial equivalence to existing legally marketed devices. It states that "In vivo performance data were presented. Additional supporting in vitro data were supplied," but does not provide any details about these studies or their results related to acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and study details as the information is not present in the provided input. The questions in your prompt are tailored for AI/ML device performance evaluations, which are not applicable to this 510(k) submission for a bone void filler material.
§ 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.