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Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip 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 BiModal Foam Strip is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BiModal Foam Strip 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 process.

Vitoss BiModal Foam Strip 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. Pore diameters in the scaffold range from 1 to 1000 um.

Vitoss BiModal Foam Strip guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BiModal Foam Strip 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.

This document is a 510(k) Summary for the Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip. It describes the device, its intended use, and demonstrates its substantial equivalence to predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The "Summary of the Performance Data" section lists various verification tests but does not provide quantitative acceptance criteria or detailed results of those tests.

Therefore, much of the requested information cannot be extracted from this document alone.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Note: The document states "the predefined acceptance criteria was met" for each, but does not specify what those criteria were (e.g., " Wettability > X %," "Porosity within Y-Z range"). It also does not provide the quantitative results (e.g., "Wettability = 95%").

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

This information is not provided in the document. The document refers to "risk analysis" and "design verifications and validations" but does not detail the methodology, sample sizes, or data provenance for these tests.

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 in the document. The document refers to "verifications" and "validations" but does not mention expert involvement in establishing ground truth. This is likely a submission for a medical device that does not involve imaging or diagnostic accuracy studies where expert ground truth is typically assigned.

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

This information is not provided in the document.

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 information is not applicable/provided in the document. This device is a bone graft substitute, not an AI diagnostic tool.

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

This information is not applicable/provided in the document. This device is a physical bone graft substitute, not an algorithm.

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

The "ground truth" for this type of device would generally be established through various engineering, biocompatibility, and animal (if applicable) studies that confirm the device materials and performance meet established standards and benchmarks. The document mentions "Design Validation," "Biocompatibility," "Wettability," "Porosity," and "Bioactivity Verification." These would each have their own associated methods for establishing "truth" or meeting specifications, often through laboratory testing, not human consensus on diagnostic images. The specific type of "ground truth" used for each verification is not detailed in this summary.

8. The sample size for the training set:

This information is not applicable/provided in the document. As a physical medical device, there is no "training set" in the context of machine learning.

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

This information is not applicable/provided in the document.

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