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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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The Pro-Fix™ Precision Fixation System is used to stabilize, fixate and/or support bone grafts, bone filling materials and/or barrier membranes used for regeneration of bone in the oral cavity.

Not Found

I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for a medical device (Pro-Fix™ Precision Fixation System). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical effectiveness studies (like MRMC studies) for an AI/algorithm-based device.

Therefore, I cannot populate the table or answer the specific questions related to the performance study of an AI device.

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The Cytoplast® PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Cytoplast PTFE Suture." It confirms that the device has been found substantially equivalent to a predicate device.

This document DOES NOT contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document primarily focuses on regulatory clearance, device classification, and indications for use. It does not include performance data, clinical study details, or analytical validation results.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from the provided text.

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As a spacemaking device used in guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation.
As a spacemaking device used in cranio-facial guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. Not to be used in load-bearing areas.

Immix™ is a DL-polylactide resorbable polymer material intended for use by itself or in combination with other materials to create space for bone regeneration. The material is packaged individually in various amounts and supplied sterile.

The provided text describes a 510(k) premarket notification for a medical device called "Immix™ Bone Graft Extender." It outlines the device's purpose, comparison to a predicate device, and the FDA's decision regarding its substantial equivalence. However, the document does not contain any information about acceptance criteria, detailed study designs, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

The 510(k) summary focuses on establishing substantial equivalence to a legally marketed predicate device (HTR Polymer, U. S. Surgical). This process typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performs at least as safely and effectively as the predicate, often through comparisons to existing data or general performance characteristics rather than new, extensive clinical trials with specific acceptance criteria as might be seen for novel devices requiring PMA approval.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. Table of Acceptance Criteria and Reported Device Performance: This information is completely absent. The document states "The results of performance and biocompatibility testing show that the Immix™ polymer material is safe and effective for its intended use and performs at least as well as legally marketed predicate devices," but it does not specify what those performance criteria were or the actual results.
2. Sample Size and Data Provenance for Test Set: Not mentioned. It's unclear if any specific "test set" in the context of AI model evaluation was used, as this is a medical device, not an AI algorithm.
3. Number and Qualifications of Experts for Ground Truth: Not mentioned.
4. Adjudication Method: Not mentioned.
5. MRMC Comparative Effectiveness Study: Not mentioned. The device is a "bone graft extender," not an imaging or diagnostic AI tool that would typically involve human readers.
6. Standalone Performance Study (Algorithm Only): Not applicable, as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used: Not mentioned. As it's a physical implant, "ground truth" would likely refer to clinical outcomes, histological analysis, or imaging results from biocompatibility and performance studies, but these details are not provided.
8. Sample Size for Training Set: Not applicable/not mentioned. This is not an AI model requiring a training set.
9. How Ground Truth for Training Set was Established: Not applicable/not mentioned.

In summary, the provided 510(k) document is a regulatory submission for a physical medical device and does not contain the type of detailed performance study information, especially related to AI model evaluation, that your request specifies. The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to a predicate device, meaning it performs "at least as well" as the predicate based on unspecified performance and biocompatibility testing.

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As a space-making barrier in the treatment of periodontal defects and guided tissue regeneration procedures; As a grafting material containment membrane.

Cytoplast™ Resorb is a bioresorbable material. Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable. The product is supplied sterile and packaged individually in various sizes.

The provided 510(k) summary for Cytoplast™ Resorb (K993610) does not contain detailed information about acceptance criteria or a specific study that proves the device meets such criteria in terms of performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance against predefined acceptance criteria for a novel device. Substantial equivalence relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis of the provided text based on your request:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the provided document. The 510(k) summary asserts that "Osteogenics Biomedical, Inc. has concluded that the Cytoplast Resorb Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate device." This is a conclusion of equivalence rather than a report of specific performance metrics against pre-defined acceptance criteria.

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

This information is not present in the provided document. The submission does not describe a clinical study or a specific test set of data with associated sample sizes or data provenance.

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 information is not present in the provided document. Since there is no mention of a test set and ground truth establishment, these details are absent.

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

This information is not present in the provided document.

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:

This information is not present in the provided document. This device is a bioresorbable material, not an AI-powered diagnostic or assistive tool, so an MRMC study would not be applicable.

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

This information is not present in the provided document. The device is a physical barrier membrane, not an algorithm.

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

This information is not present in the provided document.

8. The sample size for the training set:

This information is not present in the provided document.

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

This information is not present in the provided document.

Summary of Device Acceptance Approach in K993610:

The acceptance of Cytoplast™ Resorb, as detailed in this 510(k) submission, is based entirely on the demonstration of substantial equivalence to an already legally marketed predicate device, the Gore Resolut XT Regenerative Material (K973594).

The core argument for acceptance is presented in Section VI. COMPARISON TO PREDICATE DEVICES:

• "The Cytoplast Resorb Barrier Membrane is similar in composition, and identical in function and intended use to legally marketed devices such as the Gore Resolut XT Regenerative Material."
• "Accordingly, Osteogenics Biomedical, Inc. has concluded that the Cytoplast Resorb Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate device."

This means that instead of defining specific performance acceptance criteria and conducting studies to meet them, the manufacturer concluded that their device is equivalent in fundamental characteristics (composition, function, intended use) to an existing device already deemed safe and effective by the FDA. The FDA's letter confirms this finding of substantial equivalence, allowing the device to be marketed.

Therefore, the "study that proves the device meets the acceptance criteria" in this context is the comparison to the predicate device as outlined by the FDA's 510(k) process for substantial equivalence, rather than a performance study against novel acceptance criteria. No specific clinical trial or human subject data related to the Cytoplast™ Resorb itself is described in this excerpt to establish its performance.

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For stabilization and support of bone grafts in dento-alveolar bony defect sites.

The Osteo-Mesh ™ TM-300 titanium ridge augmentation mesh is fabricated from Grade 1 titanium as described by ASTM-F-67 or its ISO equivalent. The Osteo-Mesh™ TM-300is supplied nonsterile in two sizes: 25 mm x 30 mm and 12 mm x 25 mm.

The biocompatibility of titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been performed with this device.

This document is a 510(k) premarket notification for a medical device, specifically a titanium mesh for bone graft stabilization. It does not contain information about a study proving the device meets acceptance criteria through performance metrics as would be expected for an AI/software-as-a-medical-device (SaMD) submission.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device already on the market. The core argument for acceptance is that the device is similar in composition and intended use to existing, legally marketed devices.

Therefore, many of the requested categories (e.g., acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's an analysis based on the provided text, indicating where information is present and where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This submission relies on substantial equivalence to a predicate device, not on meeting specific performance metrics through a clinical study or benchmark.

2. Sample Sizes Used for the Test Set and Data Provenance

Not Applicable. No test set or associated data are described for performance evaluation.

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

Not Applicable. Ground truth establishment for a test set is not part of this type of submission.

4. Adjudication Method for the Test Set

Not Applicable. No test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not Applicable. This is not a software or AI device; therefore, an MRMC study is not 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

Not Applicable. No ground truth is established in the context of device performance evaluation for this submission. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is not a machine learning or AI device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no training set.

Summary of Device Acceptance Rationale (Based on the document):

The acceptance of the Osteo-Mesh™ TM-300 is based on its substantial equivalence to a legally marketed predicate device, the OsteoMed TRAM™ (Titanium Ridge Augmentation Material) (K963394).

• Comparison Basis: The submission states that the Osteo-Mesh™ TM-300 is "similar in composition, and intended use" to the TRAM™.
• Composition: Both devices are made from Grade 1 titanium (ASTM-F-67 or ISO equivalent). The biocompatibility of titanium is cited as "established through a long history of use in a variety of implant devices."
• Intended Use: Both devices are "For stabilization and support of bone grafts in dento-alveolar bony defect sites."

The FDA's review concludes that the device is substantially equivalent to predicate devices, allowing it to be marketed under the general controls provisions of the Federal Food, Drug, and Cosmetic Act. This indicates that the safety and effectiveness are inferred from the predicate device's history and not from new, extensive performance studies detailed in this 510(k) summary.

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