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Actifuse is a synthetic bone grafting material intended to fill, augment, and/or reconstruct maxillofacial osseous bone defects including periodontal, oral and craniomaxillofacial applications. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a synthetic bone grafting material that resorbs and is replaced by bone during the healing process.

Products in the Actifuse™ family are bioactive phase-pure silicon-substituted calcium phosphate osteoconductive bone graft substitutes, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the calcium phosphate phase of Actifuse is similar to human cancellous bone.

The provided document is a 510(k) Premarket Notification for a bone graft substitute (Actifuse™ Bone Graft Substitute). This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving a device's performance against specific acceptance criteria through a clinical study as would be typical for AI/software-as-a-medical-device (SaMD) products.

Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable to this document, as it describes a material-based medical device, not a diagnostic AI or imaging device.

Here's why the prompt questions are not directly answerable by this document:

• Acceptance Criteria & Reported Performance: The document doesn't define specific quantitative performance metrics or acceptance criteria for the Actifuse device in the way an AI diagnostic device would (e.g., sensitivity, specificity). Instead, it relies on demonstrating bioactivity and osteostimulation through in-vitro studies and claiming substantial equivalence to existing predicate devices.
• Sample Size (Test Set), Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to studies evaluating AI algorithms, typically involving human interpretation of medical images or data. They do not apply to the in-vitro and in-vivo (not stated in this excerpt, but common for such devices) testing used to characterize a bone graft material.
• Ground Truth: For a bone graft, "ground truth" would likely refer to histological analysis of new bone formation in vivo or clinical outcomes. While the document mentions in-vitro studies, it does not detail a clinical study with established ground truth for performance.
• Training Set: AI models require training data. This device is a physical material, not an AI algorithm.

What the document does describe in terms of "testing" is:

1. Bench testing: "shown Actifuse™ family of devices to meet the requirements of all relevant standards for bone graft substitutes." (This implies compliance with material properties, sterility, biocompatibility, etc., but specific criteria and results are not detailed).
2. Bioactivity (in-vitro): Growth of an apatite layer in simulated body fluid, with a 29% faster formation compared to a non-silicate control.
3. Osteostimulatory (cell culture): Accelerated cellular responses (metabolic activity, proliferation) compared to a non-silicate control.

The key takeaway is that the regulatory pathway for Actifuse is based on substantial equivalence to existing devices and in-vitro characterization, not on a clinical study demonstrating AI-like diagnostic performance against a defined ground truth.

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