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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.

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