(71 days)
ßGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for use in the treatment of surgically created osseous defects or osseous defects caused by traumatic injury to the bone. ßGran Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
ßGran Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following implantation the calcium phosphate matrix will be resorbed and is replaced with bone during the healing process.
BGran is a porous, resorbable osteoconductive scaffold constructed of highly pure ß tri-calcium phosphate for use in the repair of bony defects. The material is designed and manufactured to achieve the specification set out in the standard ASTM F 1088-87 (1992) e-1.
The interconnected pores provide a three-dimensional scaffold that mimics the geometry of human cancellous bone matrix. The three-dimensional platform provided by BGran's osteoconductive scaffold guides the regenerating bone throughout the defect into which it has been implanted. Pore diameters ranging from 1 pm to 700 m support re-vascularisation and cellular invasion throughout the matrix
Studies have shown that when ß tri-calcium phosphate is implanted in direct contact with host bone, which has a viable blood supply, that it responds physiologically. Throughout the healing process the matrix resorbs and is replaced by bone and connective tissue. Complete resobption takes between 3 to 12 months
BGran is supplied as granules, available in three sieve sizes, sterile for single patient use
The provided document is a 510(k) Summary for a medical device (BGran™ synthetic osteoconductive scaffold) seeking premarket notification, indicating it's for regulatory clearance rather than a study report proving device performance against acceptance criteria in the context of AI/software.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, and expert involvement for an AI medical device is not available in this document. This document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, materials, design, and performance characteristics.
The tables within the document compare the BGran device to predicate devices (Vitoss™ Scaffold and CerasorbORTHO) regarding design and performance characteristics but do not present acceptance criteria for a study or device performance against those criteria in the manner you've described for an AI/software device. For instance, "Osteoconductivity" is listed as a performance characteristic, with the device and predicates all reporting "Osteoconductive." Similarly, "Resorption" is described with expected timelines but not as a quantitative acceptance criterion with a specific study result.
§ 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.