(60 days)
Formagraft" Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should 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 by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.
Formagraft is a bone graft substitute consisting of resorbable purified fibrillar collagen and partially resorbable hydroxyapatite/tricalcium phosphate (HA / {}-TCP) ceramic. The bovine fibrillar collagen component is biocompatible and has low immunogenicity, making it a suitable material for providing a scaffold around which new bone can grow. Both hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP) ceramic are radiopaque and highly biocompatible. HA is a polycrystalline substance with a stoichiometry similar to bone mineral and is minimally resorbed as bone grows into the scaffold. The porous B-TCP ceramic has a stoichiometry similar to amorphous biologic precursors to bone. In addition, it is biodegradable and its biodegradation products can be reconstituted by the body to form new bone mineral, allowing for bone deposition to occur. The porous HA / B-TCP ceramic has been shown to possess an osteoconductive property for filling bone defects and it can evoke a biologic response similar to that of bone.
The provided text describes Formagraft™ Collagen Bone Graft Matrix, a bone void filler, and its 510(k) clearance. However, it does not include information about specific acceptance criteria or performance studies with reported metrics in the format requested. The document focuses on regulatory classification, substantial equivalence to predicate devices, and intended use.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
The document states:
- Conformance with Performance Standards: "No performance standards have been established under Section 514."
- Voluntary Standards: It lists voluntary standards (ASTM F1185, ASTM F1088, ANSI/AAMI/ISO 11137, AAMI TIR 27) that the device complies with, relating to material composition and sterilization. These are not performance criteria in the sense of demonstrating clinical efficacy against specific numerical thresholds.
- Special Controls: It mentions the FDA CDRH guidance document Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry & FDA, June 2, 2003, as a special control. This guidance would outline the specific data and information required for clearance, but the document does not detail the specific acceptance criteria derived from this guidance or the results of studies against them.
- Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to pre-amendment or previously cleared predicate devices (Orquest, Inc. Healos Bone Graft Material; NeuColl, Inc. Collagraft Strip Bone Graft Matrix; Berkeley Advanced Biomaterials Inc. Bi-Ostetic; Orthovita Vitoss Scaffold Foam). This typically means showing similar intended use, design, and functional characteristics, rather than conducting new clinical trials with predefined performance metrics.
§ 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.