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The SurFuse ™ II Putty and ExFuse ™ II Putty are bone filling materials indicated for dental intraosseous, oral and maxillofacial defects, including periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects.

The SurFuse ™ II Putty and ExFuse ™ II Putty are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty-like consistency. The ExFuse ™ II Putty also contains cancellous bone powder. They are provided sterile for single patient use. The products are provided sterile for single patient use.

The provided text describes the 510(k) summary for the SurFuse™ II Putty and ExFuse™ II Putty, which are bone grafting materials. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and performance metrics in the way a diagnostic device submission might. Therefore, many of the requested elements for acceptance criteria and study design are not explicitly present in the provided text.

Based on the information given, here's what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence through:

• Donor Suitability: Compliance with FDA regulations (21 CFR Part 1270 and Part 1271) and AATB-certified tissue banks for donor bone.
• Viral Inactivation: Validation assessment for potency against HIV-1, BHV, BVDV, HAV, and PPV.
• Biocompatibility: Demonstrated as non-toxic and biocompatible according to ISO 10993.
• Osteoconductivity: Ability to grow bone in vivo in the dog alveolar bone model.
• Osteoinductivity: Osteoinductive potential shown in vivo in the athymic (nude) rat muscle pouch model and correlated with an in vitro BMP-2 ELISA assay.

Since specific quantitative "performance" metrics for these criteria are not given (e.g., "X% reduction in viral load," "Y units of new bone growth"), a direct table with numerical acceptance criteria and reported values cannot be constructed from the provided text. The reported "performance" is qualitative, stating that the devices met these assessments.

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

• Osteoconductivity Study: "dog alveolar bone model." The sample size (number of dogs) is not specified.
• Osteoinductivity Study: "athymic (nude) rat muscle pouch model." The sample size (number of rats) is not specified.
• Data Provenance: The studies are described as in vivo animal models. The country of origin for the studies is not specified, though the submitter is HansBiomed Corp. from Korea, and donor bone is sourced from AATB-certified tissue banks in the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable and not provided. The studies involve animal models and in vitro assays, not human clinical evaluations requiring expert interpretation of primary data (like images). The "ground truth" for osteoconductivity and osteoinductivity would be determined by histological analysis and quantitative measures in the animal models and biophysical/biochemical assays, typically assessed by pathologists or laboratory scientists, but the number and qualifications of such individuals are not detailed.

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

This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for human reader studies where there's a need to resolve discrepancies in expert interpretations (e.g., radiology case readings). These methods are not relevant to the in vivo animal model or in vitro assay studies described.

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 is not applicable and not provided. MRMC studies are for evaluating the impact of AI assistance on human diagnostic performance, typically in imaging. This device is a bone grafting material, and its evaluation does not involve AI or human readers for diagnostic purposes.

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

This is not applicable and not provided. This device is a physical material, not an algorithm.

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

• Osteoconductivity and Osteoinductivity: The ground truth appears to be based on pathology/histology and biochemical assays (BMP-2 ELISA) from in vivo animal models. The formation of new bone in the different animal models is the objective ground truth.
• Biocompatibility: The ground truth is established by adherence to ISO 10993 standards for non-toxicity and biocompatibility, likely through in vitro and in vivo tests described in those standards.
• Viral Inactivation: The ground truth is based on the effectiveness of the manufacturing and sterilization processes in inactivating specified viruses, assessed by validation studies.

8. The sample size for the training set

This is not applicable and not provided. The assessment described here involves characterization of the material's biological properties, not machine learning or AI, so there is no concept of a "training set."

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

This is not applicable for the same reason as point 8.

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