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CONFIRM™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. CONFIRM™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ Putty, Gel, Plus Gel, and Plus Crunch are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ resorbs and is replaced with bone during the healing process.

CONFIRM™ Bioactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When CONFIRM™ is placed in direct contact with host bone, new bone grows in apposition to the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by CONFIRM™.

CONFIRM™ consists of Bioglass (per ASTM F1538), hyaluronic acid, and glycerol, and is available in putty, gel, and crunch forms to accommodate surgical and anatomical needs.

This document is a 510(k) premarket notification for a medical device called CONFIRM™ Bioactive. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed study information typically associated with acceptance criteria and device performance as might be found in a clinical trial report or a more comprehensive validation study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of your specific questions about study design, ground truth, or expert involvement. The document primarily makes claims of substantial equivalence based on types of testing rather than presenting results against specific criteria.

Here's what can be extracted and what cannot:

Information that can be extracted from the provided text:

• 1. A table of acceptance criteria and the reported device performance: This detailed information is not provided in the document. The document states "Performance data demonstrates substantial equivalence to the predicate devices" and that in vivo and biocompatibility testing were conducted in accordance with a specific guidance document, but it does not present specific acceptance criteria or quantitative performance metrics against those criteria.
• 2. Sample size used for the test set and the data provenance:
  • Sample size for test set: Not specified. The document mentions "in vivo performance testing (tibial defect model and posterolateral spine fusion model)" but does not give sample sizes for these animal models.
  • Data provenance: The performance data comes from "in vivo performance testing" and "biocompatibility testing." These are likely pre-clinical (animal) studies, not human clinical trials. The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the studies were likely conducted to U.S. or international standards acceptable by the FDA. The studies are prospective in nature as they involve testing the device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Given the nature of the in vivo animal studies mentioned, "ground truth" would likely be established by veterinary pathologists or other scientific experts evaluating histological sections, imaging, or gross observations, but specifics are absent.
• 4. Adjudication method for the test set: This information is not provided.
• 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: This is not applicable and not mentioned. This device is a bone void filler, not an AI-powered diagnostic imaging device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as it's not an AI algorithm. Its performance as a standalone material is inherently what in vivo testing would evaluate.
• 7. The type of ground truth used:
  • Based on the mention of "in vivo performance testing (tibial defect model and posterolateral spine fusion model)" and the nature of bone void fillers, the ground truth would likely involve:
    • Histopathology: Microscopic examination of tissue samples from the defect sites to assess new bone formation, integration, and resorption of the material.
    • Radiographic imaging: X-rays or CT scans to observe bone healing and density.
    • Gross observation: Visual assessment of the healing site.
    • Biomechanical testing: To assess the strength of the healed bone.
  • The document implies that these methods were used to demonstrate "substantial equivalence to the predicate devices."
• 8. The sample size for the training set: This is not applicable as there is no "training set" for an AI device. The document describes in vivo studies, which are typically for performance evaluation.
• 9. How the ground truth for the training set was established: This is not applicable as there is no training set mentioned.

Summary of what the document does provide:

• Device Name: CONFIRM™ Bioactive
• Intended Use: Bone void filler and autograft extender for voids or gaps in the skeletal system (extremities, pelvis, posterolateral spine) that are not intrinsic to its stability. Must be combined with bone marrow aspirate and autogenous bone graft. Resorbs and is replaced with bone during healing.
• Device Description: Resorbable bone void filler, osteoconductive and osteostimulative. Consists of Bioglass (per ASTM F1538), hyaluronic acid, and glycerol. Available in putty, gel, and crunch forms.
• Performance Data Basis: "In vivo performance testing (tibial defect model and posterolateral spine fusion model) and biocompatibility testing were conducted in accordance with the 'Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device,' June 2, 2003."
• Conclusion: "Performance data demonstrates substantial equivalence to the predicate devices." CONFIRM™ Bioactive is similar to predicates in technical characteristics, performance, and intended use, and is as safe, effective, and performs as well as or better than the predicate devices.
• Predicates: KINEX™ Bioactive Bone Void Filler (K130392), Vitoss® BA Bioactive Bone Graft Substitute (K103173 & K994337), NovaBone® Bioactive Bone Graft (K080009).

This document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed scientific publication of study results.

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