(184 days)
InterOss® small granules are recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge .
- . Filling of infrabony periodontal defects
- . Filling of defects after root resection, apicocectomy, and cystectomy
- . Filling of extraction sockets to enhance preservation of the alveolar ridge
- . Elevation of the maxillary sinus floor
- . Filling of periodontal defects in conjunction 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)
InterOss® large granules are recommended for:
- . Augmentation or reconstructive treatment of the alveolar ridge
- . Elevation of the maxillary sinus floor
- . Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
InterOss® is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps, InterOss acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process.
InterOss® is available in granule form and is packaged in vials or a syringe-like applicator.
InterOss®, in the vial form, will be available to the United States market in 8 versions: Filled with 0.25g, 0.5g, 1.0g, 2.0g, or 5.0g of small granules (0.25 - 1.0mm) or filled with 0.5g, 1.0g, or 2.0g of large granules (1.0 - 2.0mm).
InterOss , in the syringe-like applicator form, will be available to the United States market in 6 versions: Filled with 0.25cc, 0.5cc, or 1.0cc of small granules (0.25 - 1.0mm) or filled with 0.5cc, 1.0cc, or 1.5cc of large granules (1.0mm - 2.0mm).
The syringe-like applicator was designed to deliver InterOss® granules more precisely to the intended treatment site without having to use other sterile instruments. The InterOss® granules can be wetted with either the patient's blood or sterile physiological saline solution back and then pressing down on the plunger. A removable filter cap prevents granules from falling out of the syringe-like applicator during storage and wetting.
During the manufacturing process of InterOss®, the granules are placed into a polymer syringe-like applicator or a glass vial, the vial or syringe is then capped with a rubber cap (the vial is also sealed with an aluminum cap), packaged into a polyethylene terephthalate tray, covered with a Tyvek lid, sealed, and then sterilized by gamma irradiation. The sterilized device is place in a protective package (outer box) along with its Instructions for Use and doctors notes.
All InterOss® products are supplied sterile and are intended for single use only.
The provided text describes the regulatory clearance of a bone grafting material called InterOss® and does not contain information about a medical device that relies on AI or offers performance metrics that would typically be described with acceptance criteria like sensitivity, specificity, or AUC, as commonly seen in AI/ML device descriptions.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "acceptance criteria" here are implied by the standards for bone grafting materials and the equivalence to the predicate devices.
Here's an attempt to structure the information based on the request, reinterpreting "acceptance criteria" as the properties and test outcomes required for substantial equivalence in this context:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria (Implied by Equivalence to Predicate & Standards) | InterOss® Reported Performance |
|---|---|
| Physical/Chemical Properties | |
| Crystallinity ratio | 106% |
| Phase purity | 100% hydroxyapatite |
| Ca/P ratio | 1.67 |
| Morphology | Granular and porous |
| Average granule size (small) | 568 µm (0.25 - 1.0mm range) |
| Average granule size (large) | 1625 µm (1.0 - 2.0mm range) |
| Pore interconnectivity | Positive |
| Absence of heavy metals | Confirmed |
| Soluble Ca elution (small granules) | 0.533 ± 0.016 (3 days), 0.322 ± 0.012 (7 days), 0.366 ± 0.024 (14 days) |
| Soluble P elution (small granules) | 3.723 ± 0.004 (3 days), 6.277 ± 0.079 (7 days), 5.865 ± 0.019 (14 days) |
| Soluble Ca elution (large granules) | 0.513 ± 0.018 (3 days), 0.315 ± 0.009 (7 days), 0.351 ± 0.021 (14 days) |
| Soluble P elution (large granules) | 3.640 ± 0.085 (3 days), 6.241 ± 0.041 (7 days), 5.847 ± 0.019 (14 days) |
| Pore size (small granules) | 149.1660 Å |
| Pore size (large granules) | 47.3236 Å |
| Surface area (small granules) | 114.4452 m²/g |
| Surface area (large granules) | 109.0581 m²/g |
| Solubility (small granules) | 74.274 ± 13.599 µg/mm³ |
| Solubility (large granules) | 70.247 ± 12.612 µg/mm³ |
| Average pH (small granules) | 7.86 ± 0.05 |
| Average pH (large granules) | 7.83 ± 0.05 |
| Compressive strength (small granules) | 1.00 MPa |
| Compressive strength (large granules) | 1.17 MPa |
| Physiochemical properties (comparison to Bio-Oss®) | Comparable (pore structure, microstructure, phase structure, chemical composition, residual organic substance) |
| Biocompatibility | |
| Skin Sensitization | Non-sensitizing (Stimulation Index = 1.03±0.26) |
| Mutagenicity | Non-mutagenic (Micronucleus and AMES test) |
| Intracutaneous Reactivity | No skin reactions |
| Pyrogenicity | Non-pyrogenic |
| Hemolysis | No hemolytic reaction |
| Systemic Toxicity / Cytotoxicity | Non-toxic and non-cytotoxic (Acute Systemic Injection Test and Cytotoxicity Test) |
| Systemic Toxicity (leachables) | Negative |
| Sterility | Passed (SAL 1 X10⁻⁶) |
| Bacterial Endotoxin (LAL) | Passed ( |
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.