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FIBERGRAFT™ BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). 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 with bone during the healing process. FIBERGRAFT™ BG Morsels must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.

FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

The FIBERGRAFT™BG Morsels provide an osteoconductive, resorbable, biocompatible bone graft substitute that is to be gently packed into defect sites. The FIBERGRAFT™BG Morsels are made from crystalline 45S5 bioactive glass. Each granule of BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses that has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule.

The provided document is a 510(k) summary for a medical device called FIBERGRAFT™ BG Morsels - Bone Graft Substitute. It does not describe an AI/ML medical device, nor does it detail a study involving human readers or AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML medical device's performance because the provided text is about a bone graft substitute, not an AI/ML product.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical bone graft substitute, involving:

• Physical Property Evaluations: Simulated distribution, whole package integrity, seal strength, accelerated and real-time aging tests.
• Biocompatibility Testing: ISO 10993 testing.
• Animal Studies:
  • Ovine Model: 58 skeletally mature sheep, evaluating device performance in critical sized cancellous bone defects (lateral distal femurs) over 24 weeks with interim evaluations (4, 8, 12, 24 weeks; min 3 animals/time point/group). Compared to positive control (predicate NovaBone Putty) and negative sham control (untreated defect). Data included radiographic, histological, histomorphometric, and biomechanical data.
  • Rabbit Model: 41 skeletally mature rabbits, evaluating device performance in a posterolateral spine fusion model over 26 weeks. Compared to predicate device and autograft (positive) control. Data included radiographic, histological, histomorphometric, and biomechanical data.
• In Vitro Studies: Demonstrating apatite layer formation on the surface in simulated body fluid (SBF).

This information does not align with the specific questions about AI/ML device performance, ground truth establishment by experts, or MRMC studies.

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FIBERGRAFT™ BG Morsels Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). 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 with the healing process.

FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

FIBERGRAFT™ BG Morsels provides an osteoconductive, resorbable, biocompatible bone graft substitute made from crystalline 45S5 bioactive glass. Each granule of FIBERGRAFT™ BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses which has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. FIBERGRAFT™ BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule. The primary purpose of this submission is to add the option to use blood to mix with the product prior to implantation. Changes were also made to the product trade name and the labeled volume sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FIBERGRAFT™ BG Morsels Bone Graft Substitute:

Based on the provided 510(k) summary, the device under review is primarily a modification to a previously cleared device. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the modified device remains substantially equivalent to its predicate, particularly concerning the new addition of using blood as a mixing agent.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for the "fluid absorbability," "packability," or "handling characteristics" tests. It also does not mention the country of origin or whether the data was retrospective or prospective. It only states "testing was conducted."

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

The document does not mention the use of experts or their qualifications for establishing ground truth for the performance testing. The "testing" appears to be focused on physical and material properties rather than clinical outcomes requiring expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This type of physical/material testing typically does not involve adjudication as it's not based on subjective interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study. This type of study is typically done for diagnostic imaging devices where human readers interpret results with and without AI assistance. This device is a bone graft substitute, not an imaging AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not describe a standalone algorithm performance study. This is not an AI device. The performance testing conducted was on the physical properties of the bone graft substitute.

7. Type of Ground Truth Used

For the performance assessment, the "ground truth" seems to be established physical/material property standards and the performance of the predicate device. The tests (fluid absorbability, packability, handling at time zero and after aging) are compared implicitly or explicitly against the known acceptable characteristics of the predicate and expected performance for a bone graft substitute.

8. Sample Size for the Training Set

This device is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning. The term "training set" is not applicable here.

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

Since there is no training set mentioned, this point is not applicable.

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