(148 days)
Geistlich Bio-Oss® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of infrabony 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 conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Bio-Oss Collagen® 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 conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongiosa (cancellous) Block (referred as Geistlich Bio-Oss®) are intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
Geistlich Bio-Oss® is serving as a matrix consisting of interconnected macro- and micropores. The material is highly porous and has a large inner surface area.
Geistlich Bio-Oss® is a biocompatible bone mineral matrix and is manufactured from bovine bone in a validated multistage purification process to remove the organic components.
Due to the interconnected macro and microporous system the device is hydrophilic and easv to moisten.
Geistlich Bio-Oss® is packed in a double sterile barrier system consisting of a glass vial and an outer blister. Geistlich Bio-Oss is sterilized according to validated processes by y-irradiation.
Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) bone mineral granules (Geistlich Bio-Oss®) and 10% collagen fibers in a block form.
The collagen facilitates handling and application of Geistlich Bio-Oss Collagen® and acts to hold the Bio-Oss particles at the desired place. The consistency of this material readily allows to take the shape of the defect. The collagen component is resorbed after application.
Geistlich Bio-Oss Collagen® is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
Geistlich Bio-Oss Collagen® is serving as a matrix consisting of interconnected macroand micropores. The material is highly porous and has a large inner surface area.
Geistlich Bio-Oss Collagen®is a biocompatible bone mineral matrix and is manufactured from boyine bone and collagen from connective tissue of pigs certified for human consumption according to a controlled and validated multistage purification process. From the bovine bone all organic components are removed.
Due to the interconnected macro and microporous system the device is hydrophilic and easy to moisten.
Geistlich Bio-Oss Collagen® is packed in a double sterile barrier system consisting of an inner and an outer blister. Geistlich Bio-Oss® is sterilized according to validated processes by y-irradiation.
The provided text describes devices (Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen®) that are bone grafting materials. Instead of software, these are physical medical devices, and their acceptance criteria and evaluation method differ significantly from what would be expected for a software-based AI medical device.
Therefore, many of the typical questions for AI/ML device evaluations (such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of device submission.
The "studies" described are bench tests comparing the new materials to previously cleared predicate devices using analytical methods.
Here's an interpretation of the relevant information provided:
Acceptance Criteria and Device Performance (for Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen®)
The acceptance criteria for these bone grafting materials are based on demonstrating substantial equivalence to predicate devices through physicochemical characterization. The goal is to show that the new devices, particularly with raw material from an alternative geographic source, are identical in composition and structure to the existing, cleared versions of Geistlich Bio-Oss®.
| Acceptance Criteria (Technological Characteristics) | Reported Device Performance (Geistlich Bio-Oss®) | Reported Device Performance (Geistlich Bio-Oss Collagen®) |
|---|---|---|
| Appearance | white granulate or white, porous block | white sponge-like, hard pieces of customized size |
| Moisture | less than 5% (w./w.) | less than 8% (w./w.) |
| Calcium | 35%-40% (w./w.) | 38%-42% (w./w.) |
| Phosphorous | 13.5% - 18.5% (w./w.) | 12.5% - 17.5% (w./w.) |
| X-ray Diffraction Analysis | Did not reveal any differences, confirmed crystalline hydroxyapatite. | Did not reveal any differences, confirmed crystalline hydroxyapatite. |
| Fourier Transform Infrared Spectroscopy (FTIR) | Data from new source equal to regular manufacturing lots. | Data from new source equal to regular manufacturing lots. |
| Mercury Intrusion Porosimetry | Porosity, specific pore surface area, bulk density, and bimodal pore size distribution identical to regular manufacturing lots. | Porosity, specific pore surface area, bulk density, and bimodal pore size of Geistlich Bio-Oss® component identical to regular manufacturing lots. |
Study Information (Applicable to Physical Device Substantial Equivalence)
-
Sample size used for the test set and data provenance:
- The "test set" here refers to samples of the Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® products manufactured with raw material from an "alternative geographic source."
- These samples were compared against "standard manufacturing lots" of the devices.
- The exact number of samples or batches tested for each analytical method (X-ray diffraction, FTIR, Mercury Intrusion Porosimetry) is not specified in the provided text.
- Data provenance is manufacturing samples, not patient data.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- N/A. This is a physical device characterization, not an expert-driven diagnostic evaluation. Ground truth is established by validated analytical chemistry and materials science techniques.
-
Adjudication method for the test set:
- N/A. Not applicable for analytical comparisons. The methods produce quantitative or spectral data that are directly compared.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:
- No. This is a comparison of physicochemical properties of a material, not a diagnostic or prognostic aid requiring human interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a material, not a software algorithm.
-
The type of ground truth used:
- The "ground truth" is based on the previously cleared predicate Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® products. The objective is to demonstrate that the devices produced with raw material from an alternative geographic source are identical in their critical physicochemical characteristics to the predicate versions already accepted by the FDA. This is established through:
- Validated analytical chemistry techniques (X-ray diffraction, FTIR).
- Materials science techniques (Mercury Intrusion Porosimetry).
- Gravimetric analysis (moisture, calcium, phosphorous content).
- The "ground truth" is based on the previously cleared predicate Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® products. The objective is to demonstrate that the devices produced with raw material from an alternative geographic source are identical in their critical physicochemical characteristics to the predicate versions already accepted by the FDA. This is established through:
-
The sample size for the training set:
- N/A. Not applicable for this type of device and evaluation. There is no machine learning model being "trained."
-
How the ground truth for the training set was established:
- N/A. Not applicable.
§ 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.