Search Results

Bioactys® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous or defects created from traumatic injury to bone.

BIOACTYS® is a sterile single use bioresorbable bone void filling substitute. BIOACTYS® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. Following placement in the bony voids or gap, BIOACTYS® resorbs and is replaced with bone during the healing process. BIOACTYS® is available in the form of granules.

This is a 510(k) summary for a medical device (BIOACTYS®), not a study report for an AI/ML powered device. As such, it does not contain information on acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert involvement, or MRMC studies) in the context of an AI/ML evaluation.

The document states:

• Intended Use: BIOACTYS® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous or defects created from traumatic injury to bone.
• Technological Characteristics: BIOACTYS® and the predicate devices have the same technological characteristics (60% Hydroxyapatite/40% β-Tricalcium Phosphate, similar porous structure, sterile, single-use, promote bone ingrowth by osteoconductivity).
• Non-clinical Performance Data: In vitro tests, performed according to the Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (April 28, 2005), support the substantial equivalence between BIOACTYS® and the predicate devices.
• Conclusion: BIOACTYS® is claimed to be substantially equivalent in terms of safety and effectiveness to the predicate devices as a non-structural osteoconductive bone void filler for osseous defects.

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document. The "study" mentioned here refers to in vitro tests to demonstrate substantial equivalence to predicate devices, not an AI/ML performance evaluation.

Ask a specific question about this device