Search Results

AccuFill Bone Substitute Material is an injectable, seff-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

AccuFill Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration fluid and mixed. Once mixed, the resulting paste is used to fill osseous defects. The paste can be administered to the treatment site by injection or by manual application. AccuFill hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite ("PCHA"), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. AccuFill is an osteoconductive material that is resorbed and replaced by natural bone over time.

AccuFill BSM is available in two packaging configurations: (1) AccuFill BSM is sold in a jar and can be mixed in a bowl or mixing syringe; (2) AccuFill BSM is also sold in a prefilled mixing syringe. AccuFill BSM is delivered to the osseous defect site with stainless steel AccuPort cannulas.

The provided text describes the regulatory clearance of a medical device, AccuFill Bone Substitute Material, through the 510(k) pathway. This pathway establishes substantial equivalence to legally marketed predicate devices, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as would be done for a novel, high-risk device.

Therefore, the information typically required to describe acceptance criteria and a study proving a device meets these criteria (such as sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not present in this document.

The document primarily focuses on:

• Regulatory Clearance (510(k)): Confirming the device is substantially equivalent to predicates.
• Device Description: What the device is and how it works.
• Indications for Use: What the device is intended for.
• Predicate Devices: The devices to which AccuFill is compared for substantial equivalence.
• Performance Testing: A list of non-clinical tests performed to demonstrate performance and substantial equivalence to predicates (e.g., simulated use, working time, setting time, compression strength, biocompatibility, sterility, shelf-life). These are engineering and material science tests, not clinical studies assessing human performance or diagnostic accuracy.

Based on the provided text, I cannot complete the requested tables and details regarding acceptance criteria and clinical study performance as they pertain to a human-in-the-loop or AI-driven diagnostic device. The document is for a bone substitute material, and the "performance testing" described is for its physical and biocompatible properties, not for diagnostic accuracy or human reader improvement with AI assistance.

Ask a specific question about this device