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OSSIX™ BONE is intended for the following uses:

• Augmentation or reconstructive treatment of the alveolar ridge;
• Filling of periodontal defects;
• Filling of defects after root resection, apicoectomy and cystectomy; .
• . Filling of extraction sockets to enhance preservation of the alveolar ridge;
• Elevation of the maxillary sinus floor;
• Filling of periodontal defects in coniunction with products intended for Guided Tissue Regeneration (GTR) . and Guided Bone Regeneration (GBR);
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). .

OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. OSSIX™ BONE is designed as a 3-D highly porous scaffold with physiological pH.

OSSIX™ BONE is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide; the shelf life of the device is 36 months.

Due to its porous and fibered microstructure, the matrix readily absorbs fluids, adheres to the surrounding tissues, and provides a scaffold that guides bone growth and regeneration. After implantation, OSSIX™ BONE undergoes gradual resorption in the body. Preclinical studies demonstrated that 50% or greater implant material remains at the 6-month time point.

OSSIX™ BONE is available in the following sizes: 0.125 CC (5x5x5 mm), 0.25 CC . (5x5x10 mm) and 0.5 CC (5x10x10 mm).

OSSIX™ BONE is for prescription use only; it is intended to be implanted by trained dentists or oral surgeons in clinics during routine dental surgical procedures on adults with periodontal and bony defects of the maxillo-facial complex.

The document describes a 510(k) submission for OSSIX™ BONE, a dental bone grafting material. The goal is to demonstrate substantial equivalence to a predicate device, Geistlich Bio-Oss Collagen®.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail sense for each test. Instead, it aims to demonstrate substantial equivalence to the predicate device. The performance is reported in terms of similarity to the predicate or conformance to relevant standards.

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

• Biocompatibility Testing: The specific number of samples for each biocompatibility test is not provided, but the final sterile device was tested.
• Sterility Validation: Not specified, but validated according to ISO 11135:2014.
• In vitro Product Characterization: Not specified, but involved comparisons between OSSIX™ BONE and the predicate device.
• Animal Study:
  • Sample Size: 19 Beagle dogs.
  • Data Provenance: Prospective animal study conducted in "an L-shape buccal mandibular defect model system in Beagle dogs". (Country of origin not specified, but typically conducted in controlled laboratory settings).

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

• General Note: For this type of 510(k) submission for a bone grafting material, "ground truth" often refers to objective measurements and histological findings rather than expert human interpretation in the same way it would for an AI diagnostic algorithm.
• Biocompatibility: Ground truth is established by standard laboratory methods and readouts as per ISO 10993 series. No "experts" in the sense of human readers/interpreters are explicitly mentioned for establishing ground truth, rather qualified lab personnel conducting the tests.
• Animal Study: The evaluation of performance and degradation in the animal study would involve veterinary pathologists or researchers specialized in animal models for bone regeneration. The number of such specialists is not stated, nor are their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set:

Not applicable in the context of this device and testing. The tests are primarily objective measurements (e.g., chemical analysis, physical properties, histological assessment in animal models) rather than subjective interpretation requiring adjudication among human readers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms to assess how AI assistance impacts human reader performance. OSSIX™ BONE is a medical device (bone grafting material), not an AI diagnostic tool.

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

Not applicable. OSSIX™ BONE is a material, not an algorithm. The "standalone performance" observed would be its inherent biological and physical properties demonstrated through bench and animal studies.

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

• Biocompatibility Testing: Ground truth is based on standard, validated test methodologies and predetermined acceptance criteria outlined in ISO 10993, measured by analytical equipment or observed biological responses (e.g., cell viability, presence of inflammation).
• In vitro Product Characterization: Ground truth is based on physical and chemical measurements (e.g., SEM images, XRD patterns, elemental analysis, FTIR spectra, amino acid concentrations, porosity, density, mechanical load) compared against the predicate or established standards.
• Animal Study: Ground truth involved histological analysis, examination of tissue reaction, new bone formation, and degradation of the implant, which falls under pathology and histology interpretations by trained professionals. Outcomes data (e.g., long-term success of bone regeneration) were observed over 1, 3, and 6 months in the animal model.

8. The Sample Size for the Training Set:

Not applicable. OSSIX™ BONE is a medical device (bone grafting material), not an AI algorithm that requires a "training set" in the machine learning sense. The materials and manufacturing processes are developed based on scientific principles and extensive material characterization, not by training an algorithm on a dataset.

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

Not applicable, as there is no "training set" for this type of medical device. The 'ground truth' for its development would be fundamental scientific understanding of material properties, biological responses, and established engineering principles.

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