(496 days)
Vitala® Porcine Derived Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:
-Simultaneous use with 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;
-Alveolar ridge preservation consequent to tooth extraction;
-Filling of bone defects after root resection, cystectomy, removal of retained teeth;
-Over the window in lateral window sinus elevation procedures;
-Furcation defects in multi-rooted teeth;
-Treatment of recession defects, together with coronally positioned flap;
-In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection;
-Guided bone regeneration in dehiscence defects; and
-Guided tissue regeneration in periodontal defects.
Vitala® Porcine Derived Collagen Membrane is a natural collagen membrane for use in periodontal and/or dental surgical procedures. The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile. Vitala® Porcine Derived Collagen Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Animal studies have shown that Vitala® Porcine Derived Collagen Membrane is substantially resorbed by 26 weeks.
Here's a breakdown of the acceptance criteria and study information for the Vitala® Porcine Derived Collagen Membrane, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Parameter | Reported Device Performance (Vitala® Porcine Derived Collagen Membrane) |
|---|---|
| Indications for Use | Same as Predicate Device: Guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for various dental/periodontal procedures. |
| Design | Manufactured using a standardized, controlled, multistage process. Porcine pericardium source from USDA-inspected facility in USA. Terminally sterilized by electron beam irradiation in double blister packs. |
| Mode of Action | Functions as a barrier between bone graft material and soft tissue. Serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Substantially resorbed by 26 weeks. |
| Operating Principles | Cell-Occlusive, Implantable, Resorbable, Biocompatible. |
| Material | Intact purified collagen tissue. |
| Collagen Source | Porcine pericardium. |
| Form | Membrane. |
| Color | White to off-white. |
| Sizes | Variety of sizes. |
| Resorption Time | Substantially resorbed by 26 weeks. |
| Sterilization Method | Irradiation. |
| Sterility | Sterile, SAL 10°. |
| Single Use/Reuse | Single use only. |
| Packaging | Double blister pack. |
| Tensile Strength | Tensile strength ≥ reference device (Bio-Gide® Resorbable Bilayer Membrane). |
| Denaturation Transition Temperature | Similar to predicate device. |
| Protein Analysis | Similar to predicate device. |
| Cytotoxicity | Non-cytotoxic (ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells, ISO 10993-5). |
| Implantation (Local Tissue Reaction) | Considered a non-irritant compared to the reference device at 2, 13, and 26 weeks of implantation (Intra-Oral Implant Model in Rabbits, ISO 10993-6). |
| Pyrogenicity | Non-pyrogenic. Test article extract met the requirements of the test (USP Bacterial Endotoxin Testing, Kinetic Chromogenic Method). |
| Chemical Characterization | All compounds have an acceptable margin of exposure (Chemical Characterization of Materials, ISO 10993-18). |
Study Details
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Sample sizes used for the test set and the data provenance:
- In vitro product characterization (Bench Tests): Specific sample sizes for tensile strength, denaturation transition temperature, and protein analysis are not explicitly stated. The tests were performed to compare the subject device against a reference device (Bio-Gide® Resorbable Bilayer Membrane) and the predicate device (Vitala® Resorbable Natural Collagen Membrane, K101453).
- Biocompatibility Studies:
- Cytotoxicity (ISO MEM Elution Assay): Not specified.
- Implantation (Local Tissue Reaction): An animal study was conducted in a rabbit intra-oral model. The number of rabbits is not specified.
- Pyrogenicity (USP Bacterial Endotoxin Testing): Not specified.
- Animal Study for Resorption: A canine mandibular molar furcation defect model was used. The sample size (number of canines) is not specified.
Data Provenance: The document does not explicitly state the country of origin for the reported test data. The source collagen for the device itself is specified as pigs from the United States of America. The studies are non-clinical (bench and animal studies).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a device that is compared to a predicate device and a reference device through non-clinical testing. The "ground truth" here is established through scientific methodologies (benchmarking, standardized biological assays, animal studies) rather than expert human interpretation of medical images or patient records. Therefore, a specific number of experts establishing ground truth in the typical clinical sense is not applicable. The studies were performed according to recognized international standards (ISO, ASTM, USP) and FDA guidelines, implying that the validity of the methods is widely accepted by scientific and regulatory experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers and diagnostic discrepancies. This document describes non-clinical (bench and animal) studies, where data is collected objectively through assays and measurements. Therefore, an adjudication method in this sense is not applicable.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a collagen membrane, not an AI-assisted diagnostic tool or an imaging modality requiring human reading.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This is a physical medical device (collagen membrane), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance claims relies on:
- Physical and Chemical Characterization: Standardized laboratory tests (e.g., ASTM D1708 for tensile strength, differential scanning calorimetry for denaturation temperature, SDS-PAGE for protein analysis).
- Biocompatibility Testing: Results from in vitro assays (cytotoxicity) and in vivo animal models (local tissue reaction, pyrogenicity, chemical characterization), conforming to ISO 10993 standards and USP.
- Animal Study Observations: Observations from a canine mandibular molar furcation defect model to characterize tissue reaction and resorption.
- The "ground truth" for the performance claims relies on:
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The sample size for the training set:
- This type of medical device (collagen membrane) does not involve a "training set" in the context of machine learning or AI. Its performance is demonstrated through direct physical, chemical, and biological testing, not by training an algorithm on data.
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How the ground truth for the training set was established:
- As there is no "training set" for this device, the concept of establishing ground truth for it is not applicable.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.