(430 days)
The TRUREPAIR™ Bone Graft Substitute is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The TRUREPAIR™ Bone Graft Substitute is intended to be gently packed 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 and is replaced with bone during the healing process.
TRUREPAIR™ implants use the PolyGraft technology and are porous, resorbable scaffolds composed of polylactide-co-glycolide (PLG) copolymer and calcium sulfate. The copolymer is amorphous (noncrystalline) and resorbs in four to twelve months, depending on shape and location. The device also contains Polyglycolide (PGA) fibers and a surfactant.
The provided text is a 510(k) summary for the TRUREPAIR Bone Graft Substitute. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (PolyGraft BGS) through comparison of intended use, materials, available shapes, sizes, packaging, shelf life, and sterilization.
The summary states: "Performance testing conducted includes bench and animal studies that demonstrate substantial equivalence to the PolyGraft BGS." However, it does not provide details about these studies, such as their design, sample sizes, specific performance metrics, or results against any defined acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided document.
The document indicates that the device's substantial equivalence is based on its similarity to a legally marketed predicate device, rather than a direct study demonstrating its performance against specific acceptance criteria.
§ 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.