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easy-graft™ is indicated for the treatment of intraoral / maxillofacial osseous defects. Dental and maxillo-facial Indications may include:

• . Extraction defects (alveolar ridge preservation)
• Periodontal defects .
• Peri-implant defects .
• Augmentation of deficient alveolar crest (e.g. Guided Bone Regeneration, GBR) ・
• Sinus floor augmentation .
• Defects after surgical extractions -
• Defects after removal of bone cysts
• Defects after root resection or apicoectorny
• Defects after removal of autotogous bone .

easy-graft™ contains:

• Syringe containing beta-tricalcium phosphate (β-TCP) granules coated with poly(lactide-co-alvcolide) (PLGA)
• Ampule containing BioLinker™ (N-methyl-2-pyrrolidone and water) .
  easy-graft™ is a bioresorbable, synthetic, porous bone graft substitute. It consists of two components: granules (supplied in a syringe) and BioLinker™ (supplied in an ampule). After mixing the components together, easy-graft" forms a moldable mass that can be applied directly from the syringe into the bone defect. easy-graft™ hardens in contact with body fluids, allowing a working time of approximately one minute after application into the bone defect. Depending on · blood inflow, hardening may take longer.
  easy-graft™ is provided in the particle sizes of 500 – 630 µm for smaller defects and 500 – 1000 um for larger defects.
  easy-graft™ is a biocompatible and osteoconductive material that allows for complete resorption by the body.
  easy-graft™ can be used in combination with dental membranes.
  easy-graft" contains no animal or human derived substances. β-TCP and PLGA are derived from synthetic raw materials.

This inquiry concerns a 510(k) Summary for the easy-graft™ bone grafting material, which focuses on device equivalence rather than diagnostic performance criteria or studies in the traditional sense of AI/CADe devices. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory document.

However, based on the provided text, here's what can be gathered regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for easy-graft™ are primarily based on demonstrating substantial equivalence to predicate devices and adherence to relevant standards and guidance documents. The "reported device performance" in this context refers to the demonstration that easy-graft™ meets these equivalence criteria and is safe and effective for its intended use.

| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Summary) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence | - Intended Use: Same as predicate devices (calc-i-oss, Cerasorb, Bio-Oss, FortOss Vital) for intraoral/maxillofacial osseous defects. - Materials: Equivalent materials to predicate devices (β-TCP to calc-i-oss, Cerasorb; PLA polymers and N-methyl-2-pyrrolidone to Atrisorb, Inion Membrane). - Form: Similar handling properties to predicate devices (CalMatrix, Fortoss Vital - moldable, implant, hardening in defect). Identical granule shape/size to calc-i-oss. - Porosity: Porous, like predicate devices (calc-i-oss, Cerasorb, BioOss). - Resorption/Bone Growth: Resorbs and replaced by bone during healing, like predicate devices (calc-i-oss, Cerasorb, FortOss Vital). - Mode of Action: Displays the same osteoconductive mode of action as predicate bone graft substitute devices (calc-i-oss, Cerasorb). | The document explicitly states: "The results of the chemical and physical characterization, biocompatibility and performance testing / evaluations demonstrate substantial equivalence of easy-graft™ to the predicate devices in intended use, technological characteristics and performance." |
| Risk Mitigation (as per FDA Guidance) | - Ineffective Bone Formation: Addressed by physical characterization (FDA Guidance Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices), chemical composition testing (same guidance), animal testing, and labeling. - Adverse Tissue Reaction: Addressed by physical characterization, chemical composition testing (same guidance), biocompatibility in accordance with #G95-1 (FDA Blue Book Memorandum, ISO-10993), animal testing, and labeling. - Infection: Addressed by sterilization according to ISO 11137 (SAL < 10^-6) and labeling. - Improper Use: Addressed by labeling. | - Chemical composition testing and physical characterization demonstrated equivalence. - Biocompatibility tests and sterility testing concluded the device is biologically safe. - Animal implantation test comparing easy-graft™ and Bio-Oss showed "No significant differences were detected in terms of osseointegration of the material, bone formation, or defect bridging. Degradation of the graft particles of easy-graft™ was evident." - Clinical case reports confirmed bone formation at the site of device application. - "No new issues of safety or effectiveness were identified during the testing of the device." |
| Sterility | Sterilization according to ISO 11137 (SAL < 10^-6) | "Sterility testing conclude[d] that easy-graft™ is biologically safe for its intended use." (Implies meeting SAL < 10^-6). |
| Biocompatibility | In accordance with #G95-1 (FDA Blue Book Memorandum, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing). | "Biocompatibility tests and the sterility testing conclude that easy-graft™ is biologically safe for its intended use." (Implies meeting ISO 10993 requirements). |

2. Sample Size Used for the Test Set and Data Provenance

The document mentions an "animal implantation test" and "Clinical case reports." It does not specify the sample size for the animal test nor the number of clinical case reports. The provenance (country of origin for data, retrospective/prospective) is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This is not a diagnostic device or an AI/CADe device where expert review establishes "ground truth" for a test set. The "ground truth" in this context is based on biological response in animal models and clinical outcomes in case reports.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of expert adjudication for defining outcomes in the context of this device's evaluation.

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

Not applicable. This is not an AI/CADe device, and no MRMC study was conducted or is relevant for this type of medical device submission.

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

Not applicable. This is a bone grafting material, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The closest concept to "ground truth" used for performance evaluation is:

• Histopathological analysis and biological outcomes from the animal implantation test (osseointegration, bone formation, defect bridging, material degradation).
• Clinical observation and outcomes data from the clinical case reports (confirmation of bone formation).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/CADe device that uses a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/CADe device that uses a "training set."

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