(226 days)
BioSet™ XC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g., the extremities, spine, ilium and/or 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.
BioSet™ XC is a combination of bovine bone processed with the BioCleanse Tissue Sterilization Process, human demineralized bone matrix, and porcine gelatin. BioSet™ XC is available in volumes from 1 to 32cc.
The provided text is a 510(k) summary for the BioSet™ XC device and an FDA clearance letter. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
The document describes the device, its intended use, and its technological characteristics, primarily focusing on its composition and how it relates to predicate devices for demonstrating substantial equivalence. The FDA letter confirms the device's clearance based on this substantial equivalence.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details based on the provided text.
§ 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.