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The intended use of PerioGlas Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:

• Periodontal/Infrabony defects
• Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
• Extraction sites maintenance/augmentation, implant (ridge preparation/ placement)
• Sinus lifts
• Cystic cavities
• Cranio-facial augmentation

For larger defects, a mixture of PerioGlas Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

PerioGlas Putty is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects and is supplied sterile. PerioGlas Putty is a two-component device composed of a synthetic bioactive glass particulate mixed with a binder. The a melt-derived calcium-phosphorus-sodium-silicate major component is designed specifically for for its absorbability (Bioglass) particulate and osteoconductive nature. The second component is gelatin powder, selected for its biocompatibility and physical gelation properties to act as a temporary binding agent for the particulate. The gelatin is rapidly absorbed from the graft site to permit tissue infiltration between the Bioglass particles and replacement of the particles by host bone during the healing process.

I'm sorry, but the provided text does not contain the information needed to answer your request. The document describes a 510(k) premarket notification for a medical device (PerioGlas Putty - Bioactive Bone Graft Gel) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is primarily about regulatory clearance based on substantial equivalence, not a detailed performance study with the metrics you've requested.

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