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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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