Search Results

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® 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 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 defects.

Geistlich Bio-Gide® Forte 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 defects.

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® is provided in the following sizes: 13 x 25 mm, 25 x 25 mm, 30 x 40 mm, 40 x 50 mm.

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® Forte 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® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 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.

The provided FDA 510(k) clearance letter and associated S510(k) summary documents describe a class II medical device, Geistlich Bio-Gide and its variants, which are resorbable bilayer membranes and bone grafting materials. This submission is for a determination of substantially equivalent to a predicate device.

Crucially, this document is focused on demonstrating substantial equivalence based on material characteristics, manufacturing processes, and performance data for the device itself (a physical membrane and bone grafting material), not on the performance of an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and effect sizes for AI assistance are not applicable to this type of medical device submission. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted to confirm the physical and biochemical properties of the new device are equivalent to the predicate device, especially after changes to supplier and manufacturing processes.

Here's an attempt to extract relevant information and note the inapplicable sections based on your request:

Acceptance Criteria and Device Performance (for a physical medical device)

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

Since this is not an AI/ML device, the acceptance criteria are not typically expressed in terms of accuracy, sensitivity, or specificity. Instead, they are based on physical, chemical, and biological properties demonstrating equivalence to a predicate device. The performance data provided is primarily comparative to the predicate.

The "analysis" column in the provided tables consistently states "The material of construction is identical," "The sizes offered are identical/similar," etc., implying the acceptance criterion is indeed identity or substantial similarity to the predicate.

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

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of an AI/ML model. The performance data consists of various physical, biochemical, and experimental tests. The number of samples for each specific test (e.g., number of membranes for tensile strength testing) is not provided.
• Data Provenance: Not specified regarding country of origin. The studies are described as "in vitro and in vivo biocompatibility," "sterilization," "shelf-life," "bench," and "clinical performance studies" leveraged from previous predicate device submissions (e.g., K212463, K171643). These are likely a mix of lab-based and potentially historical clinical data. It is not specified if these are prospective or retrospective studies; however, given they are leveraged from previous clearances, they would be historical for this specific submission.

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)

• Not Applicable. This is not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in that manner. The "ground truth" for a resorbable membrane involves objective physical, chemical, and biological measurements, and comparison to established standards and predicate device characteristics, not expert consensus on image interpretation.

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

• Not Applicable. No human adjudication method is described or relevant for the physical and chemical performance tests conducted on this medical device.

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

• Not Applicable. This is not an AI-assisted device, so MRMC studies are not relevant.

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

• Not Applicable. This is not an AI algorithm. Its "standalone" performance refers to its intrinsic physical and chemical properties.

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

• Not Applicable / Different Context. The "ground truth" for this device's performance is established by:
  • Objective Measurements: Results of standardized physical and biochemical tests (e.g., SEM, porosity, tensile strength, DSC, solubility, degradation, molecular weight, hydration capacity, suture pull-out force).
  • Regulatory Standards: Compliance with ISO and ASTM standards (e.g., ISO 10993-1, ISO 11137 series, ISO 22442-3, ASTM F2450-18, ASTM F2150-19, ASTM F2212-20).
  • Predicate Device Data: Comparison and leveraging of performance data (biocompatibility, sterilization, shelf-life, bench, clinical) from previously cleared predicate devices. The claim is substantial equivalence, meaning it performs as safely and effectively as the legally marketed predicate.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary of the Study Proving Device Meets Acceptance Criteria (in this context):

The "study" conducted for the Geistlich Bio-Gide product family in this 510(k) submission primarily consists of a comprehensive battery of non-clinical performance tests combined with the leveraging of existing performance data from previously cleared predicate devices. The purpose of these tests was to demonstrate that modifications (e.g., new slaughterhouse, non-significant manufacturing changes) did not alter the fundamental safety and effectiveness of the device, making it substantially equivalent to its predicates.

The non-clinical tests included:

• Physical and Biochemical Testing: SEM (surface morphology), porosity, tensile strength, DSC (onset temperature), suture pull-out force, solubility, enzymatic degradation, SDS-PAGE (molecular weight distribution), and hydration capacity. For Geistlich Bio-Gide Forte and Compressed, handling properties were also evaluated.
• Other Experimental Testing: Viral safety according to ISO 22442-3:2007.

These tests, performed on the modified devices, aimed to show that their properties were consistent with a product that would continue to perform as intended and as safely and effectively as the predicate devices. The acceptance criteria were implicitly that the new devices exhibit equivalent performance characteristics to the cleared predicate devices, as supported by these various in vitro and experimental studies and referencing past clinical data from the predicates.

Ask a specific question about this device

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

Study Details

1. 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.

2. 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.

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

   • This information is not provided in the 510(k) summary.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

Ask a specific question about this device

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® 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.
• guided bone regeneration in dehiscence 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.
• guided tissue regeneration procedures in periodontal defects.

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 Mucograft® and Geistlich Mucograft® Seal are indicated for:

• covering of implants placed in immediate or delayed extraction sockets;
• localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
• alveolar ridge reconstruction for prosthetic treatment; and
• recession defects for root coverage.

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. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich BioGide® 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® 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 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.

Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.

Here's an analysis of the acceptance criteria and supporting study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For all listed devices (Geistlich Bio-Gide®, Geistlich Bio-Gide® Shape, Geistlich Bio-Gide® Compressed, Geistlich Bio-Gide® Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft® and Geistlich Mucograft® Seal), the acceptance criteria are not explicitly stated as numerical thresholds. Instead, the criterion for acceptance is that the material properties remain unchanged when using an alternate supplier of porcine raw material compared to the predicate devices. The reported device performance is that these properties did remain unchanged.

Specific Performance Studies Conducted:

• Elongation: Verified to be unchanged.
• Suture pull-out test: Verified to be unchanged.
• Swelling: Verified to be unchanged.
• Differential Scanning Calorimetry (DSC): Verified to be unchanged.
• Collagenase digestion (to assess degradation): Verified to be unchanged.
• Scanning Electron Microscopy (SEM) (to assess optical differences): Verified to be unchanged.
• Viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007: Verified (leveraged from K171050).
• Biocompatibility, sterilization, shelf-life, and clinical performance: Leveraged from the applicant's own predicate devices, implying these aspects also remained consistent.

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

The document does not explicitly state the numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, the performance studies were conducted on "representative product" for each device to verify material properties. The provenance of this "representative product" is not specified (e.g., country of origin). The studies appear to be laboratory-based and not involving patient data, so the terms "retrospective" or "prospective" are not applicable.

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

This information is not provided in the document. The studies performed are physical and chemical characterizations of the material, not clinical evaluations requiring expert interpretation of results. The "ground truth" for these tests would be the established scientific methods and parameters for each test.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the physical and chemical tests, it's unlikely a human-based adjudication method (like 2+1 or 3+1) would be used. The results of these tests are typically objectively measured and compared to established specifications or to the predicate device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a material change (alternate raw material supplier) and not a new diagnostic or therapeutic device requiring human interpretation of results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical bone grafting material/membrane, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on objective physical and chemical material properties and standards. The performance of the modified devices (with the alternate raw material supplier) was compared to the known performance and characteristics of the predicate devices. The determination of "unchanged" would rely on laboratory measurements meeting predefined specifications or falling within an acceptable range relative to the predicate device.

8. The Sample Size for the Training Set

This question is not applicable. This submission is about a physical medical device and a change in its raw material supplier. There is no machine learning model or "training set" involved.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for an AI/ML model.

Ask a specific question about this device

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.
• quided bone regeneration in dehiscence defects.

Geistlich Bio-Gide® Compressed is indicated for:

• auqmentation 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.
• guided tissue regeneration procedures in periodontal defects

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 14mm x 24mm, respectively. With the exception of the size and shape, Geistlich Bio-Gide® Shape is the same as its predicate device, Geistlich Bio-Gide® Perio (K112575).

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. With the exception of the size and a minor difference during manufacturing to mark the dense surface of the membrane, which should face the soft tissue, Geistlich Bio-Gide® Compressed is the same as its predicate device, Geistlich Bio-Gide® Perio.

The provided text describes Geistlich Bio-Gide® Shape and Geistlich Bio-Gide® Compressed, which are collagen membranes used as bone grafting materials. The 510(k) submission argues for their substantial equivalence to predicate devices, rather than establishing acceptance criteria for a new device's performance metrics. As such, explicit acceptance criteria with numerical targets and a study designed to prove the device meets those new acceptance criteria (as would be typical for novel devices with distinct performance claims) are not presented in this document.

Instead, the documentation focuses on demonstrating that the new devices are substantially equivalent to existing legally marketed predicate devices by showing they have:

• The same intended use.
• Similar technological characteristics.
• Similar performance and safety profiles.

The "studies" described are primarily to support this claim of substantial equivalence by showing that material properties, biocompatibility, and clinical outcomes are consistent with the predicate and reference devices.

Therefore, for this specific submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since the submission is for substantial equivalence, formal acceptance criteria in the traditional sense of a new performance threshold are not explicitly stated for Geistlich Bio-Gide® Shape or Geistlich Bio-Gide® Compressed. Instead, the "acceptance criteria" are implied to be "demonstrates substantial equivalence to the predicate device" based on the following characteristics and their performance relative to the predicate:

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

• Geistlich Bio-Gide® Shape & Compressed (for testing against predicate):
  • Test Set Sample Size: Not applicable in the context of a new efficacy study. The "test set" here refers to the actual manufactured devices (Geistlich Bio-Gide® Shape and Compressed) subjected to physical/chemical, sterility, biocompatibility, and usability testing to confirm they meet specifications and are comparable to the predicate. The exact number of units tested for each characteristic is not specified.
  • Data Provenance: The manufacturing and testing data are from Geistlich Pharma AG, Switzerland. This is directly related to the newly submitted devices.
• Clinical Data (from reference devices):
  • An animal study related to Geistlich Bio-Gide® (K960724).
  • A clinical study of 75 patients examining Geistlich Bio-Gide® as a barrier membrane for guided bone regeneration in simultaneous implant placement.
  • Another clinical study involving 15 patients and 16 Geistlich Bio-Gide membranes for defect filling.
  • Several clinical studies on Geistlich Bio-Gide® for guided tissue regeneration procedures in periodontal defects:
    • Recession defects: 20 patients (pairs of defects).
    • Furcation defects: 52 grade II mandibular molar furcation defects; 21 patients with 31 furcation defects.
    • Intrabony defects: 22 paired intrabony defects; 28 patients (each with one intrabony defect); 124 patients (each with at least one intrabony defect); two studies with 4 intrabony defects each.
  • Data Provenance for Clinical Studies: The specific countries of origin for these clinical studies are not provided in the document. They are generally referenced as "clinical testing data from the K960724 and K042197 reference devices," implying these studies were conducted prior to this submission and are being cited to support the equivalence claim. The studies appear to be prospective clinical trials assessing the performance of the reference device.

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

• Not directly applicable. "Ground truth" in this context would typically refer to a definitive diagnosis or outcome for a diagnostic device. For these devices (bone grafting materials), the assessment criteria are objective (e.g., meeting chemical specifications, biocompatibility, histological evaluation in animal models, and clinical outcomes reported in existing literature).
• The clinical studies referenced would have involved clinicians (dentists, periodontists) who assessed the outcomes and established the "truth" for those studies. However, the exact number and qualifications of these experts are not provided in this summary.

4. Adjudication Method for the Test Set:

• Not applicable as this is not a diagnostic device requiring human adjudication in the described testing. Assessment involves laboratory tests, biocompatibility assays, and clinical outcomes from human studies, not consensus of human readers on images or test results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure improvements in diagnostic accuracy or efficiency.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

• Not applicable. These devices are physical materials (collagen membranes) for bone grafting, not algorithms or software. Their performance is assessed through material properties, biocompatibility, and clinical outcomes, not as a standalone algorithm.

7. Type of Ground Truth Used:

• For material and biocompatibility testing: Laboratory Assay Results, Chemical Specifications, Histological Evaluation (animal study).
• For clinical studies (referenced for Geistlich Bio-Gide® family): Clinical Outcomes (e.g., gain of root coverage, decrease of recess depth, pocket reduction, gain in clinical attachment level (CAL), vertical/horizontal defect fill, radiographic appearance, and histological evaluation in some cases), and Safety Data (adverse events). These are objective clinical measurements and observations.

8. Sample Size for the Training Set:

• Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets. The "training" for these devices would be the extensive research and development and prior clinical experience with similar collagen membranes.

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

• Not applicable, as this is not an AI/ML device that uses a training set.

Ask a specific question about this device

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;
• 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);
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

The two products are being packaged together as a convenience kit for the ease of clinician use in periodontal regenerative procedures. In addition, Geistlich Bio-Gide® Perio will be packaged and sold as individual units.

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 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.

The provided text describes the Geistlich Perio-System Combi-Pack, a medical device for bone and tissue regeneration, and refers to performance data from published studies to demonstrate its substantial equivalence to predicate devices. However, the document does not contain the level of detail requested for acceptance criteria, specific device performance metrics, or study design parameters (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information).

The document states:

• "Performance Data: A published nonclinical animal study provides histological evidence that Geistlich Bio-Gide® Perio, in combination with Geistlich Bio-Oss Collagen®, regenerates bone in 5 mm diameter rabbit femoral defects (1). Several published clinical studies demonstrate improvements in clinical attachment levels and probing pocket depths through 5-year follow-up versus the control (access flap surgery) (2,3,4). Histological evaluation of teeth in a case series demonstrated periodontal regeneration (5)."
• "The results of these published studies demonstrate the substantial equivalence of Geistlich Bio-Gide® Perio and Geistlich Bio-Oss Collagen® to their respective predicate devices."

Based on this, here's what can be extracted and what is missing:

Acceptance Criteria and Study Details for Geistlich Perio-System Combi-Pack

The provided K112575 submission indicates that the device's performance was evaluated through a review of published nonclinical and clinical studies demonstrating substantial equivalence to predicate devices. However, the specific, quantitative "acceptance criteria" for the device's performance as a whole, typical of what one might find for a diagnostic or AI-based device, are not explicitly stated in this document. Instead, the performance claims refer to evidence of bone regeneration and improvements in clinical metrics from prior studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds typically found in AI/ML device submissions. Instead, "performance criteria" are inferred from the outcomes described in the referenced studies, which relate to the intended use and demonstrate effectiveness comparable to predicate devices.

Missing Information Analysis:

The provided text does not contain the following information:

2. Sample size used for the test set and the data provenance: The document references external published studies. The sample sizes for these studies are not provided in this 510(k) summary. Data provenance (e.g., country of origin, retrospective/prospective) is also not detailed here, as these are summaries of individual publications.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information would be found within the methodologies of the referenced studies, but it is not included in the 510(k) summary. For histological evaluations, experts (e.g., pathologists, histologists) would have established ground truth, but their number and qualifications are not specified here.
4. Adjudication method for the test set: Not specified in this 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a bone and tissue regeneration material, not an AI/ML-based diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device (bone/tissue graft material), not an algorithm or AI.
7. The type of ground truth used:
   • Histology: For bone regeneration and periodontal regeneration, histology was used.
   • Clinical measurements: For clinical attachment levels and probing pocket depths, direct clinical measurements were used.
   • Outcomes: The ultimate "ground truth" related to the success of treatment in the clinical studies involves patient outcomes (e.g., sustained improvements over 5 years).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device