(242 days)
Geistlich Bio-Gide® is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Gide® Compressed is indicated for:
- augmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets.
- localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment.
- filling of bone defects after root resection, cystectomy, removal of retained teeth.
- guided bone regeneration in dehiscence defects, and
- guided tissue regeneration procedures in periodontal teeth.
Geistlich Bio-Gide® Perio is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects, and
- guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Gide® Shape is indicated for:
- augmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets.
- localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment.
- filling of bone defects after root resection, cystectomy, removal of retained teeth; and
- guided bone regeneration in dehiscence defects.
Geistlich Combi-Kit Collagen:
Geistlich Bio-Gide® is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in periodontal defects.
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 Perio-System Combi-Pack:
Geistlich Bio-Gide® Perio is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in periodontal defects.
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-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.
Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.
Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Geistlich Bio-Gide family of devices.
Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed de novo device performance study with specific acceptance criteria and detailed clinical outcomes for a novel device. As such, direct "acceptance criteria" and "device performance" in a quantitative sense (like sensitivity/specificity targets) for a new algorithm are not explicitly stated in this type of document. Instead, the "acceptance criteria" here are implicitly meeting the performance characteristics and indications for use of the predicate device, backed by non-clinical and clinical data on the predicate.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Leveraged from Predicate Studies) |
|---|---|
| Material characteristics equivalent to predicate. | Identical (Porcine collagen) |
| Manufacturing and sterilization methods equivalent to predicate. | Identical (Gamma sterilization) |
| Packaging and size equivalent to predicate. | Similar sizes for Bio-Gide; identical for Bio-Gide Shape, Bio-Gide Compressed, Bio-Gide Perio, Combi-Kit Collagen, and Perio-System Combi-Pack |
| Biocompatibility in accordance with ISO 10993-2018. | Leveraged from predicate (K192042), indicating compliance. |
| Sterilization effectiveness (SAL) in accordance with ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017. | Leveraged from predicate (K192042), indicating compliance. |
| Shelf-life stability equivalent to predicate. | Leveraged from predicate (K192042), indicating stability. |
| Similar bench performance to predicate. | Leveraged from predicate (K192042), implying similar performance. |
| Clinical performance for various dental defect types (e.g., bone growth, defect size reduction, alveolar ridge preservation). | "Complete wound closure is not required when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls." (Based on 15 clinical studies involving 297 unique patients). |
Study Details
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 297 unique patients across 15 clinical studies.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be historical clinical studies from the applicant's predicate devices (K192042), making them retrospective in nature for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. Given that the studies involved "evaluation for new bone growth and defect size" and "alveolar ridge preservation," the evaluations were likely performed by dental or oral surgery professionals, but their specific number or qualifications are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the 510(k) summary.
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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:
- No MRMC study was done. This is a medical device submission for a physical bone grafting material/membrane, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth appears to be clinical outcomes data from human patients, including measurements of new bone growth, defect size reduction, and alveolar ridge preservation. These outcomes would have been evaluated by clinicians, potentially by consensus or standardized measurement protocols, but the specifics are not detailed.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The "performance data" section leveraged historical clinical studies from the predicate device as evidence of safety and effectiveness for the subject device.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.