(118 days)
Actifuse™ Actifuse™ ABX E-Z-fil Putty, Actifuse™ Shape Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process. Actifuse™ Flow Actifuse™ Flow Bone Graft Substitute is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse™ Flow Bone Graft Substitute can be injected into bony voids or gaps of the skeletal system. i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Actifuse™ is a bioactive phase-pure silicon-substituted calcium phosphate osteoconductive and osteostimulative bone void filler, 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.
This 510(k) summary describes a resorbable calcium salt bone void filler, Actifuse™. It isn't a typical AI/software device that would have specific performance metrics like sensitivity/specificity for diagnosis. Instead, the acceptance criteria and supporting studies focus on the biological and material properties of the bone graft substitute.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties: | |
| Composition | Bioactive phase-pure silicon-substituted calcium phosphate osteoconductive and osteostimulative bone void filler. Single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. Interconnected and open porous structure similar to human cancellous bone. |
| Compliance with relevant standards for Calcium Salt Bone Void Fillers | Testing has shown Actifuse™ to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. |
| Bioactivity: | |
| Induction of an apatite layer in vitro | Induced growth of an apatite layer on the surface of Actifuse following exposure to simulated body fluid. |
| Rate of apatite layer formation | Time required to form a new apatite layer was reduced by 29% when compared to an identical calcium phosphate material that did not contain 0.8wt% silicate. |
| Osteostimulation: | |
| Acceleration of cellular responses (metabolic activity, proliferation) in vitro | Cell culture studies showed accelerated cellular responses (metabolic activity and proliferation) compared to an identical material without 0.8wt% silicate. |
| Functional Outcome: | |
| Scaffold for rapid bone repair via bony infiltration | Confirmed Actifuse™ to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold. |
| Resorption and replacement by bone during healing | The product provides a bone void filler that resorbs and is replaced by bone during the healing process (stated in indications for use and implied by other tests). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated with specific numbers of samples for each test (e.g., number of in-vitro samples, number of cell cultures). The documentation generally refers to "in-vitro studies" and "cell culture studies."
- Data Provenance: The studies are described as "in-vitro studies" and "cell culture studies," implying laboratory-based testing. There is no mention of human or animal in-vivo test sets beyond the general assertion that "testing has confirmed Actifuse™ to be safe and effective." The document explicitly states: "The bioactive and osteostimulatory nature of Actifuse has not been correlated with human clinical experience." This indicates the data is from ex vivo (in vitro) experiments rather than in vivo clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable in the context of this submission. The device is a material, not an imaging or diagnostic AI device that requires expert-established ground truth for performance evaluation. The "ground truth" for the material's properties generally comes from validated chemical, biological, and mechanical testing methods.
4. Adjudication Method for the Test Set
- Not applicable. As a material, there's no "adjudication method" in the sense of reconciling human expert opinions on a diagnostic outcome. Performance is based on objective scientific measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a bone graft substitute, not an AI or software device. Therefore, no MRMC study involving human readers and AI assistance would be relevant or conducted for its approval.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a bone graft substitute, not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the material's performance relies on scientific measurements and established biological assays. This includes:
- Chemical and structural analysis of the material for composition and porous structure.
- In-vitro studies using simulated body fluid to observe apatite layer formation.
- Cell culture studies to measure cellular responses (metabolic activity, proliferation).
- Compliance with "relevant standards for Calcium Salt Bone Void Fillers," which would imply adherence to material and biocompatibility ground truths defined by those standards.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product (a bone graft substitute), not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, this question is not relevant. The material's development and characterization would have involved standard scientific research and development procedures to understand its properties.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.