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Fortoss® Vital is intended for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.

Fortoss® Vital bone graft substitute is a calcium salt based pre-measured powder and liquid component. The two components are designed to be mixed intraoperatively to produce a homogeneous paste which can then be applied to osseous defects. The product is provided sterile for single patient use. When Fortoss® Vital is placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.

This document is a 510(k) summary for the Fortoss® Vital bone graft substitute. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding acceptance criteria and a study to prove meeting those criteria is not present.

However, I can extract what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the Fortoss® Vital. Instead, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a predicate device. The primary "performance" reported is its equivalence to the predicate in key characteristics.

2. Sample size used for the test set and the data provenance:

• Sample size for the test set: Not provided. The document refers to "Data supplied" and "Documentation provided" but does not specify a test set size for animal or human studies. The nature of a 510(k) submission, especially for a bone graft substitute demonstrating substantial equivalence, often relies on comparing existing data or characteristics to a predicate, rather than conducting new, large-scale clinical trials.
• Data provenance: Not explicitly stated regarding specific studies. The applicant is Biocomposites Ltd, located in Keele, Staffordshire, England. This suggests the data might originate from or be compiled in the UK. The document uses terms like "Non Clinical Testing," implying laboratory or animal studies, but specifics on provenance are absent.

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 as this submission is not about an AI/ML device that requires expert adjudication for ground truth establishment. It's a medical device (bone graft substitute) submission focused on substantial equivalence.

4. Adjudication method for the test set:

This information is not provided as it's not relevant for this type of medical device submission.

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 provided as this device is a bone graft substitute, not an AI/ML diagnostic tool.

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

This information is not provided as this device is a bone graft substitute, not an AI/ML algorithm.

7. The type of ground truth used:

For a bone graft substitute, "ground truth" would typically refer to established biological and material science principles, existing clinical performance data of the predicate, and possibly pre-clinical (e.g., animal model) results. The document states "Data supplied demonstrates that the modified Fortoss® Vital is substantially equivalent to the predicate device." This implies the ground truth is derived from the known characteristics and performance of the predicate device, potentially supported by laboratory testing on the new device verifying these characteristics.

8. The sample size for the training set:

This information is not provided as this is not an AI/ML device that utilizes a training set.

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

This information is not provided as this is not an AI/ML device.

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Fortoss Vital™ is indicated for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.

Fortoss Vital™ Bone Graft Substitute is a calcium phosphate based bone graft substitute and is provided sterile for single patient use. When Fortoss Vital™ is placed in the defect, bone grows in apposition to the implant, filling the pores with new bone during the healing process.

Fortoss Vital™ is completely resorbed and replaced with bone during the healing process.

The provided text is a 510(k) summary for a medical device called Fortoss Vital™. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a specific clinical study with acceptance criteria and performance metrics for the device itself as a diagnostic or analytical tool.

Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable or available within this document because:

• Fortoss Vital™ is a bone graft substitute, not a diagnostic or AI-driven device. The 510(k) summary is for a physical implantable material. Such devices are typically evaluated through non-clinical testing (chemical composition, biocompatibility) and clinical usage experience, not through studies that establish performance metrics like sensitivity/specificity against a ground truth as would be done for an AI/diagnostic tool.
• The document emphasizes "substantial equivalence" to predicate devices. The primary goal is to show the new device is as safe and effective as existing legally marketed devices, rather than establishing novel performance benchmarks.
• "Clinical Testing" section notes clinical use with no adverse events. This is a general statement about post-market surveillance or observational use, not a controlled study designed to meet specific acceptance criteria and report quantitative performance metrics.

In summary, the nature of the device (a bone graft substitute) and the purpose of the document (a 510(k) premarket notification for substantial equivalence) mean that the specific clinical study details you've requested are not present here.

If the request were for a diagnostic or AI-powered device, the 510(k) summary or an accompanying clinical study report would typically contain much of the information you've asked for.

Ask a specific question about this device