(194 days)
FIBERGRAFT™ BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels 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 Morsels must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
FIBERGRAFT™ BG Morsels 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 Morsels provide an osteoconductive, resorbable, biocompatible bone graft substitute that is to be gently packed into defect sites. The FIBERGRAFT™BG Morsels are made from crystalline 45S5 bioactive glass. Each granule of BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses that has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule.
The provided document is a 510(k) summary for a medical device called FIBERGRAFT™ BG Morsels - Bone Graft Substitute. It does not describe an AI/ML medical device, nor does it detail a study involving human readers or AI assistance.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML medical device's performance because the provided text is about a bone graft substitute, not an AI/ML product.
The document focuses on demonstrating substantial equivalence to a predicate device for a physical bone graft substitute, involving:
- Physical Property Evaluations: Simulated distribution, whole package integrity, seal strength, accelerated and real-time aging tests.
- Biocompatibility Testing: ISO 10993 testing.
- Animal Studies:
- Ovine Model: 58 skeletally mature sheep, evaluating device performance in critical sized cancellous bone defects (lateral distal femurs) over 24 weeks with interim evaluations (4, 8, 12, 24 weeks; min 3 animals/time point/group). Compared to positive control (predicate NovaBone Putty) and negative sham control (untreated defect). Data included radiographic, histological, histomorphometric, and biomechanical data.
- Rabbit Model: 41 skeletally mature rabbits, evaluating device performance in a posterolateral spine fusion model over 26 weeks. Compared to predicate device and autograft (positive) control. Data included radiographic, histological, histomorphometric, and biomechanical data.
- In Vitro Studies: Demonstrating apatite layer formation on the surface in simulated body fluid (SBF).
This information does not align with the specific questions about AI/ML device performance, ground truth establishment by experts, or MRMC studies.
§ 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.