(30 days)
Actifuse ™ Shape 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 Shape 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™ Shape 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 of the calcium phosphate phase of Actifuse Shape is similar to human cancellous bone.
The provided text is a 510(k) Premarket Notification summary for Actifuse™ Shape, a bone void filler. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) application would.
Therefore, the document does not contain information on many of the requested items, particularly those related to human-in-the-loop studies, ground truth establishment with experts, or detailed statistical performance metrics of the device as if it were an AI diagnostic tool.
However, I can extract the information that is present and indicate where the requested information is not available:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet requirements of relevant standards for Calcium Salt Bone Void Fillers. | "Testing has shown Actifuse™ Shape to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." (Specific standards are not enumerated in this summary.) |
| Safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold. | "Testing has confirmed Actifuse™ Shape to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold." (No specific quantitative metrics for "rapid bone repair" or "bony infiltration" are provided in this summary. The safety and effectiveness are primarily supported by substantial equivalence to the predicate device, Actifuse™ ABX E-Z-fil Putty, K071206, which also implies similar indications, contraindications, risks, and potential adverse events.) |
| Substantial Equivalence to Predicate Device (Actifuse™ ABX E-Z-fil Putty, K071206). | "Actifuse™ Shape is composed of a porous calcium salt equivalent to that contained in the predicate device... The technologies employed in Actifuse™ Shape and its predicate device are therefore substantially equivalent. Actifuse™ Shape has the same indications, contraindications, risks and potential adverse events as the predicate device and thus substantial equivalence is claimed for the device." (The FDA's decision to clear the device confirms this claim of substantial equivalence, allowing it to be marketed.) |
Additional Information Not Present in the Provided Document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The "testing" mentioned is likely bench testing or pre-clinical animal studies to confirm material properties and biocompatibility, rather than human clinical trials with defined test sets for performance metrics in a diagnostic or AI context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable in this context. The evaluation is not based on expert-adjudicated diagnostic performance of an AI.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is a bone void filler, not an AI diagnostic tool for image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a bone void filler involves demonstrating its material properties, biocompatibility, and ability to be resorbed and replaced by bone, likely through in vitro and in vivo (animal) studies mimicking the human healing process. No specific "ground truth" establishment with human experts for diagnostic purposes is described.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document implies for this specific device:
The Actifuse™ Shape is a Class II medical device, cleared through the 510(k) pathway, meaning it demonstrates "substantial equivalence" to a legally marketed predicate device. The "testing" referred to is primarily to confirm its material characteristics, biocompatibility, and functionality (resorption and scaffolding for bone repair) meets relevant standards and is comparable to the predicate. This is a very different type of submission and testing methodology compared to what would be expected for an AI-powered diagnostic tool, which typically involves extensive clinical data, human reader input, and statistical performance metrics against a defined ground truth.
§ 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.