(197 days)
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.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.