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MBCP* ™ is intended for use as bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and 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.
MBCP+TM is provided sterile for single patient use.

MBCP+™ is a non structural bone graft substitute, which is resorbable and able to be replaced by newly-formed bone. The MBCP+™ is a ceramic constituted of two-phase of calcium phosphate 20 % hydroxyapatite and 80 % tricalcium phosphate beta. MBCP+™ is presented in a porous form.
There are two types of porosity in MBCP+TM:
The microporosity (pores smaller than 5μm) is constituted by all the spaces between the ceramic. The microporosity allows the biological fluids to circulate.
The macroporosity (pores diameters bigger than 100µm) provides a porous scaffold upon which bone formation can occur at the expense of the ceramic.

The provided document for K063527 does not contain the detailed acceptance criteria and study information typically associated with AI/ML device evaluations. This submission pertains to a resorbable bone substitute (MBCP+™), which is a medical device and not an AI/ML diagnostic or therapeutic system.

Therefore, the requested information regarding acceptance criteria, performance metrics (like sensitivity, specificity, AUC), sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this 510(k) submission.

The submission focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for use: MBCP+™ is intended for use as bone void filler for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.
• Anatomic sites: Extremities, spine, and pelvis.
• Design: Porous ceramic with microporosity (pores smaller than 5µm for fluid circulation) and macroporosity (pores bigger than 100µm for bone formation).
• Material: Two-phase calcium phosphate (20% hydroxyapatite and 80% tricalcium phosphate beta).
• Function: Resorbable bone substitute replaced by newly-formed bone.

The "acceptance criteria" for this type of device in a 510(k) context are essentially the successful demonstration of substantial equivalence to a legally marketed predicate device, as confirmed by the FDA's clearance letter. This typically involves showing that the new device is as safe and effective as the predicate, often through material characterization, biocompatibility testing, and functional comparisons, rather than AI-specific performance metrics.

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