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MBCP™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP™ can be used with autogenous bone grafting materials.

Typical uses include:

• Periodontal/Infrabony defects .
• Ridge augmentation .
• Extraction sites (implant preparation/placement) .
• Sinus lifts .
• Cystic cavities .

MBCP™ is a Resorbable Bone Graft Substitute.

MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (ß-TCP).

MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human cancellous bone.

MBCP™ is presented in a porous form required for the biological exchanges particularly for bone ingrowth and mineralization.

The balance of a stable component (HA) and a more bioactive component (B-TCP) allied to the porosity involves the controlled process of ceramic resorption and bone substitution.

When packed into the bony site, MBCP™ gradually resobs and is replaced with bone during the healing process.

This document is a 510(k) Summary of Safety and Effectiveness for the MBCPTM device, a resorbable calcium salt bone void filler. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, the provided text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with pre-defined acceptance criteria for every new submission. In this case, the document states: "The safety and effectiveness of MBCP™ Resorbable Bone Graft Substitute for Dental Bone Grafting is adequately supported by the substantial equivalence information as well as biocompatibility testing, safety and performance data provided within this Premarket Notification." This implies that the 'study' referred to is likely a combination of literature review, in vitro tests (biocompatibility), and possibly a verification of physical/chemical properties that align with the predicate device, rather than a clinical trial with specific performance metrics and acceptance thresholds.

Given the information provided, I cannot populate the table or answer the questions related to specific acceptance criteria, study design, sample sizes, expert involvement, or comparative effectiveness studies. The document emphasizes substantial equivalence based on material composition and intended use.

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