(170 days)
The PolyGraft™ BGS 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 PolyGraft™ BGS 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.
PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGraft™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
The provided text is a 510(k) summary for the PolyGraft™ BGS device, which is a resorbable bone void filler. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/algorithm-based device.
Therefore, the requested information elements (acceptance criteria, study details for AI performance, sample sizes for test/training, expert ground truth, MRMC study, standalone performance) are not applicable to this document because it describes a physical medical device (bone graft substitute) and not an AI or algorithm-based device.
The "Testing" section describes the studies conducted to show substantial equivalence to predicate devices, which are:
- Biocompatibility assessment: Performed by independent certified laboratories to demonstrate material compatibility.
- Degradation testing: Performed in a simulated body fluid at 37 ℃ to show substantially equivalent degradation rate to predicate devices.
- Rabbit metaphyseal defect study: An in vivo study comparing bone formation and biomechanical properties of PolyGraft™ BGS to predicate devices at six weeks, demonstrating similar histological bone formation and equivalent biomechanical properties.
These studies serve to justify the substantial equivalence claim, which is the basis for 510(k) clearance for this type of device, rather than meeting specific performance metrics typically associated with AI device 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.