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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 is a phase-pure calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse™ is similar to human cancellous bone.

The provided text is for a 510(k) Premarket Notification for a bone graft substitute called Actifuse. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study to establish performance against acceptance criteria in the same way one would for a novel diagnostic AI device. Therefore, much of the requested information (like sample sizes for test sets, expert-established ground truth, MRMC studies, or training set details) is not present because it is not typically part of a 510(k) for a bone void filler based on material composition.

Here's an analysis of the available information in the context of the provided document, addressing what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

The document doesn't define explicit numerical acceptance criteria for device performance as you would expect for an AI diagnostic device (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device and adherence to relevant standards for Calcium Salt Bone Void Fillers.

• Same indications for use
• Same technological characteristics
• Same contraindications, risks, and potential adverse events | Actifuse™ is composed of a porous calcium salt equivalent to that contained in the predicate device and to that in routine clinical use.
  Actifuse™ has the same indications, contraindications, risks and potential adverse events as the predicate device. |
  | Safety and Effectiveness:
• Meeting requirements of all relevant standards for Calcium Salt Bone Void Fillers
• Providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold | Testing has shown Actifuse™ to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers.
  Testing has confirmed Actifuse™ to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold. |
  | Material Composition:
• Phase-pure calcium phosphate
• 0.8wt% silicon (Si) incorporated into crystalline structure
• Interconnected and open porous structure similar to human cancellous bone | Actifuse is a phase-pure calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold... 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse™ is similar to human cancellous bone. |

Study Information (Based on Available Document)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not specified. The document states "Testing has shown Actifuse™ to meet the requirements of all relevant standards" and "Testing has confirmed Actifuse™ to be safe and effective." However, it does not provide details about the specific studies, sample sizes, or data provenance. For a bone graft substitute, this "testing" would typically refer to biocompatibility, mechanical properties, and possibly animal studies, not human clinical test sets in the context of AI.

2. 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/Not specified. This pertains to establishing ground truth for diagnostic devices, particularly AI. For a bone graft substitute, "ground truth" would be established through laboratory analyses, histological examination (in animal studies), and potentially clinical follow-up for bone formation, but not typically through an expert panel reviewing diagnostic images.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. This is relevant for diagnostic image review.

4. 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:

   • No, an MRMC study was not done. This type of study is specific to evaluating AI-assisted diagnostic tools.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No. This device is a physical bone graft substitute, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated in detail, but inferred "ground truth" for a bone graft substitute's performance would typically involve:
     • Biocompatibility testing (e.g., cell culture, implantation models).
     • Histological analysis (in animal studies) to confirm bone ingrowth and resorption.
     • Mechanical testing of the material.
     • Chemical analysis to confirm composition.
   • The document states "the product provides a bone void filler that resorbs and is replaced by bone during the healing process," implying that evidence of resorption and bone replacement would be the ultimate "outcome data" or "pathology" in relevant studies.

7. The sample size for the training set:

   • Not applicable/Not specified. This product is not an AI algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. This product is not an AI algorithm that requires a training set.

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