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Geistlich Fibro-Gide® is intended for soft tissue augmentation. It is indicated for:

• Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants A
• Alveolar ridge reconstruction for prosthetic treatment A
• Recession defects for root coverage A

Geistlich Fibro-Gide® is a fully resorbable, porous, collagen matrix of porcine origin of a spongious consistency. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. The collagen scaffold is weakly crosslinked. Geistlich Fibro-Gide® is sterilized in double packaging by Gamma-irradiation.

Geistlich Fibro-Gide® is an implantable device intended for use in soft tissue augmentation procedures. As described in more detail below, the device is indicated specifically for insufficient tissue volume at the alveolar ridge and for soft tissue recession. It has mechanical properties appropriate to withstand the mechanical stresses that occur after wound closure in soft tissue augmentation procedures, i.e., it has good volume stability and it withstands early resorption to allow the formation of new soft tissue and degrades over time. In addition, the matrix is designed with an appropriate thickness to provide sufficient space for the ingrowth of new soft tissue. Due to its good wettability, suturability and biological properties, the device becomes well integrated into the surrounding soft tissue.

The provided text describes a 510(k) premarket notification for a medical device called Geistlich Fibro-Gide®. This document focuses on demonstrating substantial equivalence to a predicate device (Geistlich Mucograft®) rather than establishing novel safety and effectiveness criteria. Therefore, the information provided does not contain traditional "acceptance criteria" for a new device's absolute performance against a set standard, but rather criteria for demonstrating similarity to an already approved device.

Here's an analysis based on the categories you provided:

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

Since this is a substantial equivalence submission, "acceptance criteria" are implicitly defined by the characteristics of the predicate device. The performance shown is a comparison to that predicate.

• Localized gingival augmentation (KT)
• Alveolar ridge reconstruction
• Recession defects for root coverage | - Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants
• Alveolar ridge reconstruction for prosthetic treatment
• Recession defects for root coverage |
  | Dimensions | 15x20 mm, 20x30 mm (K102531), 30x40 mm (K073711, K012423) (thickness app. 2.5 - 5 mm) | 15x20 mm, 20x40mm (thickness app. 6mm) |
  | Form | Sponge-like matrix | Sponge-like matrix |
  | Color | Almost white | White to almost white |
  | Porosity | Very porous materials with average pore values of 90% or more. The average surface area and the bulk density are almost identical. | Very porous materials with average pore values of 90% or more. The average surface area and the bulk density of Geistlich Fibro-Gide® is almost identical to that of Geistlich Mucograft. |
  | Capillarity and wettability | Spontaneously wettable and completely soaked in aqueous solution in less than one minute | Spontaneously wettable and completely soaked in aqueous solution in less than one minute |
  | Cross-linking | Not chemically cross-linked | Chemically cross-linked with EDC and NHS |
  | Easy to trim | Can be cut with surgical instruments | Can be cut with surgical instruments |
  | Can be sutured | Can be fixed with sutures, as demonstrated by sutureability testing | Can be fixed with sutures, as demonstrated by sutureability testing |
  | Raw Material | Porcine connective tissue, Porcine skin tissue | Porcine connective tissue, Porcine skin tissue |
  | Composition | Porcine collagen: Product is produced from the same intermediate collagenous products | Porcine collagen: Product is produced from the same intermediate collagenous products |
  | Collagen / Elastin | Major protein components Collagen I and Collagen III (no Collagen II) and Elastin | Major protein components Collagen I and Collagen III (no Collagen II) and Elastin |
  | Amino Acid Composition | Very similar with equal amounts of amino acids | Very similar with equal amounts of amino acids |
  | Fat | Trace (less than 0.5%) | Trace (less than 0.5%) |
  | Glycosaminoglycans | Trace (less than 0.5%) | Trace (less than 0.5%) |
  | Other proteins | None (>0.5%) | None |
  | pH | 3-7 | 3-7 |
  | Source of raw material | Identical porcine tissue | Identical porcine tissue |
  | Manufacture | Multistage validated, SOP controlled purification process | Multistage validated, SOP controlled purification process |
  | Manufacturing conditions | Quality systems regulation (CFR Part 820) | Quality systems regulation (CFR Part 820) |
  | Packaging | ISO 11607, Parts 1 and 2 compliant. Sterile double layer packaging in aluminum pouch. | Conforms to ISO 11607, Parts 1 and 2. Sterile double layer packaging, including aluminum layer to protect against vapor penetration. |
  | Sterilization | Gamma irradiation SAL 10-6; sterile, single use | Gamma irradiation SAL 10-6; Device provided sterile, for single use only |
  | User | Restricted to licensed dentists | Restricted to licensed dentists |
  | Biocompatibility | (Implicitly passed the same ISO 10993 tests as the subject device) | Passed all tests: Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Pyrogenicity, Genotoxicity (Bacterial reverse mutagenicity, Chromosomal aberration, Micronucleus study), Local tissue response after implantation (4, 12, 26-week subcutaneous), Subchronic systemic toxicity, Chronic systemic toxicity, Leachables. |
  | Animal Study Effectiveness | (Implied safe and effective based on predicate's approval) | Demonstrated tissue integration, continuous resorption, and comparable degradation rate to predicate. Acceptable safety profile for distal organs, hematologic parameters, and clinical chemistries. Demonstrated substantial equivalence in soft tissue augmentation and local tissue effects. |
  | Clinical Data (Effectiveness/Safety) | (Implied safe and effective based on predicate's approval) | Demonstrated product safety and effectiveness in the product's indications for use. |

Key finding regarding acceptance criteria: The acceptance criteria for Geistlich Fibro-Gide® are defined by its ability to demonstrate substantial equivalence to Geistlich Mucograft® across various characteristics, including physical properties, composition, manufacturing, and performance in biocompatibility, animal, and clinical studies. The "performance" is that it "passes" these comparative tests.

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

• Bench Testing: No specific sample sizes are provided for the bench tests. The data provenance is not explicitly stated as country of origin, but the sponsor and manufacturing/sterilization locations are in Switzerland. The testing is assumed to be prospective, undertaken for this submission.
• Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of L929 fibroblast cultures, rabbits, guinea pigs, mice, rats) are not explicitly stated in this summary. The tests adhere to ISO 10993 standards, suggesting standard methods and sample sizes for these types of studies. The provenance of these animal studies is generally considered prospective, conducted for regulatory submission.
• Animal Studies (Rat and Dog): "a rat and in a dog study" – exact number of animals is not provided. These were conducted "compliant with 21 CFR Part 58" (Good Laboratory Practice for Nonclinical Laboratory Studies), indicating prospective and controlled studies. The country is not specified, but given the sponsor and manufacturing locations, it is likely Europe (Switzerland) or a contracted lab.
• Clinical Data: "The clinical data from a controlled, parallel and randomized study in patients presenting insufficient soft tissue volume." The sample size (number of patients) is not provided. This describes a prospective study design. The country of origin for the clinical data is not specified.

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):

This document does not describe the establishment of a "ground truth" by experts in the context of diagnostic accuracy, which is common for AI/imaging devices. Instead, the ground truth for this medical device is:

• Bench testing: Established by laboratory measurements and adherence to scientific standards.
• Biocompatibility: Established by adherence to ISO 10993 standards and generally accepted biological endpoints.
• Animal studies: Established by histological examination, physiological measurements, and comparison to the predicate, likely reviewed by veterinary pathologists or relevant scientists.
• Clinical study: The "ground truth" for safety and effectiveness is derived from the clinical outcomes of the study itself, assessed by the investigators and clinicians involved in the trial.

There is no mention of a panel of experts specifically establishing a "ground truth" for the test sets in the way an imaging device might rely on expert consensus.

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

No adjudication method for disagreements among experts is described, as the studies primarily involve objective measurements (benchmarks, lab results) or clinical trial outcomes rather than subjective interpretations requiring adjudication.

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 device is a collagen matrix for soft tissue augmentation, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers improve with AI vs without AI assistance" are irrelevant to this submission.

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

Not applicable. This device is a physical implantable medical device, not an algorithm or AI.

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

The "ground truth" for this submission consists of:

• Bench testing results: Objective measurements of physical, chemical, and functional properties.
• Histopathology and physiological data from animal studies: Pathological findings and biological responses in animal models.
• Clinical outcomes data: Measurements and assessments of patient safety and effectiveness endpoints from a clinical trial.

8. The sample size for the training set:

Not applicable. This device is a physical product, not an AI/ML model that requires a training set.

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

Not applicable. (See #8)

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Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; 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.

MUCOGRAFT® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to MUCOGRAFT® resorbable bilayer membrane (K012423), but labeled with an additional indication: guided tissue regeneration in periodontal defects. MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.

This is a 510(k) premarket notification for a medical device called MUCOGRAFT®, a resorbable bilayer membrane used for guided tissue and bone regeneration. The submission aims to establish substantial equivalence to previously cleared predicate devices, specifically BIO-GIDE® (K960724; K042197; and K050446) and MUCOGRAFT® (K012423), with an additional indication for "guided tissue regeneration procedures in periodontal defects."

The document states that the new MUCOGRAFT® is physically identical to the previously cleared MUCOGRAFT® (K012423), and the primary basis for substantial equivalence is the existing clearances and the comparison to BIO-GIDE® (K042197) which already includes the new indication sought for guided tissue regeneration in periodontal defects.

Therefore, the submission does not describe a new study to prove the device meets acceptance criteria. Instead, it relies on the substantial equivalence principle, asserting that the device is essentially the same as already cleared devices, particularly the predicate device BIO-GIDE® for the new indication.

Given this, many of the requested details about acceptance criteria and study design are not present in this 510(k) summary. I can, however, extract the comparative information presented in lieu of specific acceptance criteria from a new study.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present a formal table of "acceptance criteria" against newly generated "reported device performance" from a dedicated study for the MUCOGRAFT® device. Instead, it demonstrates substantial equivalence to predicate devices based on product characteristics and intended use. The table provided is a comparison of MUCOGRAFT® to its predicate device, BIO-GIDE®, highlighting their similarities, which serves as the basis for regulatory acceptance.

2. Sample size used for the test set and the data provenance

• Not applicable. The submission does not describe a new test set or study conducted for this specific 510(k) submission. It relies on the equivalence to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No new study for ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable. No new test set or adjudication method is described.

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 device is a resorbable membrane, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a resorbable membrane, not an algorithm.

7. The type of ground truth used

• Not applicable (for this submission). For the original clearance of the predicate devices (BIO-GIDE® and initial MUCOGRAFT®), the ground truth for their effectiveness would have been established through pre-clinical testing, animal studies, and potentially clinical trials (outcomes data, histological evidence of regeneration, etc.) as required for their initial 510(k) clearances. This specific submission relies on referencing those prior clearances.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device, so there is no "training set."

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

• Not applicable. See point 8.

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