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Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (non- resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.

Cytoplast™ Titanium-Reinforced PTFE Membranes are placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect.

Cytoplast™ Titanium-Reinforced PTFE Membranes are composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is biologically nearly inert and a tissue-compatible material.

The PTFE membranes are designed to maintain space and conform to tissue contours.

Cytoplast™ Titanium-Reinforced PTFE Membranes are provided in two different thicknesses (approximately 150 µm & 250 µm) and are pre-shaped in a variety of shapes and sizes.

The provided text describes a 510(k) summary for a medical device and does not contain information about an AI/ML powered device, a comparative effectiveness study, or details related to establishing ground truth for a test set in the context of an AI/ML device.

Therefore, I cannot provide the requested information in the format of a table for acceptance criteria and device performance as it pertains to AI/ML or a study that proves a device meets AI/ML specific acceptance criteria. The document describes a traditional medical device (Cytoplast™ Titanium-Reinforced PTFE Membranes) and its substantial equivalence to predicate devices based on non-clinical testing.

Here's a breakdown of what can be extracted in relation to the questions asked, adapted to the context of the provided document:

Acceptance Criteria and Device Performance (Non-AI/ML context)

Further Details (where applicable to the provided document):

1. Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML. The "test set" here refers to the samples of the Cytoplast™ Titanium-Reinforced PTFE Membranes subjected to various non-clinical bench tests (e.g., for tensile strength, lamination). Specific sample sizes for each test are not explicitly stated in the summary, but the tests were performed on the device itself.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert-labeled images) is not relevant here. The "truth" for these non-clinical tests is determined by standardized protocols (e.g., ASTM D638-14 for tensile strength) and material characterization.
3. Adjudication method for the test set: Not applicable. This document describes physical and material property testing, not subjective assessment requiring adjudication.
4. 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/ML device, and no MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the non-clinical tests is established by industry standards, physical measurements, and chemical/biological assays. For instance, biocompatibility is evaluated against established ISO 10993 cytotoxicity, irritation, and toxicity standards. Tensile strength is objectively measured.
7. The sample size for the training set: Not applicable. There is no AI/ML model involved, and therefore no training set.
8. How the ground truth for the training set was established: Not applicable.

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RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indication and support of bone grafts in alveolar bony defect sites.

RPM™ Reinforced PTFE Mesh is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE mesh helps create the space needed for bone-derived cells to repopulate and repair the defect. RPM™ Reinforced PTFE Mesh is composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is a biologically inert and tissue-compatible material. RPM™ Reinforced PTFE Mesh is manufactured with circular 0.66 mm diameter macropores to allow direct contact between the bone graft and the periosteum. Direct contact between the periosteum and bone graft allows naturally occurring revascularization and infiltration of cells. The PTFE mesh is designed to maintain space and conform to tissue contours. RPM™ Reinforced PTFE Mesh is provided pre-shaped in a variety of shapes and sizes.

The provided text describes a 510(k) premarket notification for the RPM™ Reinforced PTFE Mesh, a medical device for bone grafting. The document focuses on demonstrating substantial equivalence to predicate and reference devices through non-clinical testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample sizes used for each in vitro bench test. It mentions that "in vitro product characterization testing was performed" and "A series of bench tests were conducted."
The data provenance is from non-clinical testing (in vitro characterization studies and biocompatibility studies). No information about country of origin for the data is provided, but it's generated as part of a US FDA submission. The studies are prospective in the sense that they were conducted specifically for this submission to evaluate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. The "ground truth" in this context is established by the design and execution of the scientific tests based on recognized standards (ASTM, ISO). There are no human "experts" establishing ground truth in the way one would for image interpretation in AI. The testing itself is the ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The test results are objective measurements against established standards and comparisons to reference devices.

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 submission is for a physical medical device (reinforced PTFE mesh), not an AI/imaging diagnostic device. Therefore, no MRMC study was conducted or is relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

• Performance against established industry standards: ASTM D638-14 for tensile strength, and ISO 10993-5 and ISO 10993-10 for biocompatibility.
• Comparative performance against legally marketed predicate/reference devices: The specified predicate device (Osteo-Mesh™ TM-300) and reference devices (Cytoplast™ Regentex™ Titanium 250 and Bio-Gide® Resorbable Bilayer Membrane) serve as benchmarks for tensile strength, lamination strength, and suture retention force.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI device or a study involving a "training set" in that sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable. Refer to point 8.

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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

Study Details

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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