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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.

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