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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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OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

• Ridge augmentation for later implant insertions.
• Simultaneous ridge augmentation and implant insertions.
• Ridge augmentation around implants inserted in delayed extraction sites.
• Ridge augmentation around implants inserted in immediate extraction sites.
• Alveolar ridge preservation consequent to tooth (teeth) extraction(s).
• Over the window in lateral window sinus elevation procedure.
• In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
• In intra bony defects around teeth.
• For treatment of recession defects, together with coronally positioned flap.
• In furcation defects in multi rooted teeth.
• Localized gingival augmentation.

OSSIX® VOLUMAX is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from veterinary certified pigs and is purified and cross-linked using ribose. OSSIX® VOLUMAX is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration. Available in sizes: 10x12.5 mm, 15x25 mm, 25x30 mm and 10x40 mm. Intended for use by dental surgeons.

This document is a 510(k) Pre-market Notification for the OSSIX® VOLUMAX resorbable collagen membrane. It aims to demonstrate substantial equivalence to a predicate device, OSSIX® PLUS. The information provided primarily focuses on the comparison between the new device and its predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not present a formal table of "acceptance criteria" for performance metrics in the way a typical efficacy study might. Instead, it compares the technological characteristics of the OSSIX® VOLUMAX (subject device) with the OSSIX® PLUS (predicate device) and demonstrates that performance is either substantially equivalent or superior in relevant aspects. The underlying acceptance criterion for the subject device is to perform at least as well as the predicate device for demonstrating substantial equivalence.

Here's a table based on the comparison provided:

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

• Non-clinical (In Vitro) Tests: The document lists various in vitro tests (heavy metals, endotoxins, collagenase resistance, tensile strength, etc.). It does not specify sample sizes for each of these in vitro tests, but implies standard laboratory testing was conducted to characterize the material.
• In Vivo Animal Study:
  • Sample Size: 19 animals (Beagle dogs).
  • Data Provenance: Not explicitly stated, but typically these studies are conducted in a controlled laboratory setting by the manufacturer or a contract research organization. It is a prospective animal study.
• Biocompatibility: Leveraged from previous submission of the predicate device. For the individual pyrogenicity test, sample size for rabbits is not mentioned but usually involves a small number of animals (e.g., 3-8).

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 510(k) submission is for a medical device (collagen membrane) and relies on non-clinical (in vitro and animal) studies, along with a comparison to a predicate device, rather than a clinical study requiring expert ground truth for interpretation of human patient data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic performance (e.g., radiologists interpreting images) is not applicable here.

The "experts" involved would be the scientists and veterinarians conducting the animal study, the laboratory personnel performing the in vitro tests, and the regulatory experts overseeing the submission. Their qualifications are implied by adherence to recognized standards like ISO and USP.

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

Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers independently interpret data (e.g., images) and discrepancies need to be resolved. This submission relies on objective physical, chemical, and biological measurements from laboratory and animal studies.

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 a medical device (collagen membrane), not an AI diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. As noted above, this is a physical medical device, not an algorithm.

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

The "ground truth" for the studies performed primarily consists of:

• In vitro studies: Objective measurements against established scientific and engineering principles and recognized standards (e.g., tensile strength, chemical composition, porosity).
• Biocompatibility: Adherence to recognized ISO standards (ISO 10993 series) and specific tests like the Rabbit Pyrogen Test (USP ). The "ground truth" here is the biological response (or lack thereof) confirming safety.
• In vivo animal study: Histological analysis, evaluation of degradation, and assessment of tissue response and performance in the defect model, performed by veterinary pathologists and researchers. The "ground truth" is the observed biological outcome in the animal model.
• Predicate comparison: The ground truth for substantial equivalence is that the new device is as safe and effective as the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

Not applicable.

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