(50 days)
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™ Flow is phase-pure silicon-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure inherent of the source material for the mineral phase of Actifuse is similar to human cancellous bone. Actifuse Flow is available as a hydrated putty.
This is a submission for a medical device (Actifuse™ Flow Bone Graft Substitute) and not an AI/ML device, so many of the requested fields (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies) are not applicable. The provided document is a 510(k) Premarket Notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than performance metrics of an AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Meet requirements of all relevant standards for Calcium Salt Bone Void Fillers | Confirmed to meet requirements of all relevant standards for Calcium Salt Bone Void Fillers |
| Safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold | Confirmed to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device (bone graft substitute), not an AI/ML device. The testing referenced is bench testing on the physical properties of the material, not a clinical study on human data in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable (see point 2).
4. Adjudication method for the test set
Not applicable (see point 2).
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 not an AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI.
7. The type of ground truth used
For bench testing, the "ground truth" would be established by the physical and chemical properties of the material itself and its performance against established engineering or biological standards for bone graft substitutes. The document states "Bench testing has shown Actifuse™ Flow to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers" and that it was "confirmed...safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold." This suggests compliance with pre-defined criteria rather than an expert consensus or pathology review of a specific clinical outcome dataset.
8. The sample size for the training set
Not applicable. This device is not an AI.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI.
§ 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.