(113 days)
FIBERGRAFT® BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, 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. FIBERGRAFT® BG Putty must be used with autograft in the posterolateral spine.
FIBERGRAFT® BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
The FIBERGRAFT®BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRATT® BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.
The provided text does not contain information about acceptance criteria or a study that proves a device meets specific performance criteria in terms of accuracy, sensitivity, or specificity, as would be relevant for an AI/ML device.
Instead, the document is a 510(k) premarket notification for a medical device called "FIBERGRAFT® BG Putty Bone Graft Substitute". The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative accuracy metrics for software.
The performance data discussed relates to:
- Physical and chemical property evaluation studies: These confirmed in vitro functionality and bioactivity, but it explicitly states, "The in vitro bioactivity test results have not been correlated to clinical performance."
- Biocompatibility tests (ISO 10993 testing): This demonstrates the material's safety for biological contact.
- Packaging evaluations, shelf life testing, and real-time aging testing.
- Bacterial endotoxin testing.
- Functional performance animal studies:
- Ovine model: Evaluated in critical size defects in skeletally mature sheep (total of 58 tested samples). This study demonstrated evidence of new bone formation with "substantially equivalent performance compared to the predicate device."
- Rabbit posterolateral spine fusion model: Compared to predicate devices and positive controls in 71 skeletally mature rabbits. This study also showed "substantially equivalently to the predicate devices."
The animal studies used radiographic, histomorphometric, and biomechanical data to evaluate performance, which are methods for assessing bone formation and structural integrity. However, the document does not present specific acceptance criteria in a table format with corresponding device performance metrics (e.g., bone volume percentages, fusion rates above a certain threshold) that could be definitively extracted and formatted as requested. The conclusion is based on "substantial equivalence" to predicate devices, meaning it performs as safely and effectively without raising new safety or effectiveness concerns, rather than meeting a predefined quantitative performance target.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided 510(k) summary for this type of device.
§ 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.