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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™ ABX E-Z-fil Putty is phase-pure silicon-substituted hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the hydroxylapatite phase of Actifuse ABX E-Z-fil Putty is similar to human cancellous bone. Actifuse™ ABX E-Z-fill Putty is available as a hydrated putty.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Actifuse™ ABX E-Z-fil Putty Bone Graft Substitute:

Based on the provided document (K071206), the review process for Actifuse™ ABX E-Z-fil Putty was a 510(k) Premarket Notification. This regulatory pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove newfound safety and effectiveness.

Therefore, the document does not contain the typical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be seen in a study evaluating a diagnostic or AI-driven device. Instead, the "acceptance criteria" are related to demonstrating that the new device is as safe and effective as its predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the document. As a 510(k) submission primarily relies on demonstrating substantial equivalence through existing data on predicate devices and bench testing, detailed clinical "test sets" with patient data (e.g., country of origin, retrospective/prospective) are typically not included in this summary unless new clinical data was specifically required, which is not indicated here. The document mentions "bench testing," implying laboratory-based studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable/provided. Since the evaluation was based on demonstrating substantial equivalence primarily through technical characteristics and bench testing against standards, there's no mention of experts establishing a "ground truth" for a clinical test set in the context of diagnostic device validation.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. No clinical test set requiring adjudication in the context of expert consensus (like for imaging studies) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance:

This information is not applicable. The device is a bone void filler, a physical medical device, not an AI-driven image analysis or diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

This information is not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the "safety and effectiveness" claim, the ground truth was based on:

• "Relevant standards for Calcium Salt Bone Void Fillers": This implies adherence to established industry or regulatory standards for material properties, biocompatibility, mechanical performance, etc.
• "Bony infiltration of the porous scaffold": This likely refers to in vitro or in vivo (animal) studies demonstrating the biological activity of the material in promoting bone ingrowth, assessed perhaps through histological analysis or imaging.

8. The Sample Size for the Training Set:

This information is not applicable/provided. The concept of a "training set" is typically associated with machine learning or AI algorithms. For a physical medical device like a bone void filler, product development involves material science, engineering, and biological testing, rather than an AI training/testing paradigm.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/provided for the reasons stated in point 8.

In summary, the provided document for K071206 describes a 510(k) premarket notification for a physical medical device. The "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a predicate device through shared technological characteristics, intended use, and bench testing against established standards, rather than clinical trial results with specific performance metrics (like sensitivity, specificity) for a diagnostic tool or AI algorithm.

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