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Vitoss BA Bimodal Bioactive Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BA Bimodal is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BA Bimodal Bioactive Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss BA Bimodal Bioactive Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.

Vitoss BA Bimodal Bioactive Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BA Bimodal Bioactive Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

The provided text describes the 510(k) summary for Vitoss™ BA Bimodal Bioactive Bone Graft Substitute, a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance acceptance criteria for a new type of device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria for clinical performance that would typically be seen in a de novo device study (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the performance demonstrated is against established standards for general medical grade materials and through comparative testing to a predicate device.

2. Sample Size and Data Provenance for Test Set (Clinical/Performance Data)

• The submission does not describe a standalone test set with human subject data used to evaluate specific clinical performance metrics. The performance data presented are primarily technical and material characterization tests.
• The "comparative testing" mentioned (wettability, fluid retention, etc.) was likely conducted in a laboratory setting on samples of the device and its predicate, not on a human test set. Therefore, there is no information on data provenance (country of origin, retrospective/prospective) in the context of a clinical test set.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Not applicable. The submission does not detail a study involving expert assessment of a test set for ground truth establishment. The ground truth for material properties is based on accepted scientific standards and laboratory measurements.

4. Adjudication Method (Test Set)

• Not applicable. No expert adjudication method is described as there is no human-evaluated test set for performance metrics.

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

• No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI devices, where the goal is to assess improvement in human reader performance with AI assistance. The Vitoss BA Bimodal device is a bone graft substitute, not a diagnostic AI tool.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a material implant, not an algorithm. Therefore, there is no "standalone performance" in the context of an AI algorithm. Its performance is inherent to its physical and chemical properties.

7. Type of Ground Truth Used (Test Set)

• For the material and technical performance, the "ground truth" is based on:
  • Accepted Industry Standards: ASTM F 1088-04a for beta-tricalcium phosphate.
  • Laboratory Measurements: Data from tests like wettability, fluid retention, SEM, XRD, FTIR, ICP, porosity, and dissolution.
  • Biocompatibility Standards: ISO 10993-1.

8. Sample Size for the Training Set

• Not applicable. As this is not an AI device, there is no concept of a "training set" in the machine learning sense. The device's properties are designed and manufactured based on established material science and engineering principles, not through a data-driven training process.

9. How Ground Truth for Training Set Was Established

• Not applicable, as there is no training set for an AI algorithm.

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