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Collagen Dental Membrane - Conformable IIBP is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Collagen Dental Membrane - Conformable IIBP is a non-friable, resorbable membrane matrix consisting of purified intact collagen tissue derived from bovine pericardium. The membrane device is flexible and conforms to the contours of the defect site. Collagen Dental Membrane - Conformable IIBP is supplied pre-hydrated, sterile, non-pyrogenic, and for single use only.

The collagen dental membrane has a thickness of approximately 0.3 to 1.0 mm and is available in the following sizes 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the device's efficacy or performance in its intended use (e.g., successful bone regeneration rate). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and showing safety (biocompatibility).

The closest we can get to acceptance criteria in the context of this document are the results of the nonclinical tests which demonstrate the device performs as expected for a medical implant and is safe.

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

The document describes non-clinical tests (bench, in vitro, and animal studies) rather than a human clinical trial that would typically have a "test set" from a patient population.

• Bench Tests (in vitro characterization): No specific sample sizes are provided for tests like membrane thickness, conformability, suture strength, permeability, or hydrothermal transition temperature.
• Biocompatibility Studies (in vitro and in vivo):
  • Cytotoxicity (ISO Agarose Overlay): Not specified.
  • Sensitization (ISO Guinea Pig Maximization): Guinea pig. Number not specified.
  • Intracutaneous Reactivity (Acute Intracutaneous in Rabbit): Rabbit. Number not specified.
  • Acute Systemic Toxicity (ISO Systemic Toxicity in Mice): Mice. Number not specified.
  • Pyrogenicity (USP Pyrogen Study – Material Mediated): Not specified (typically rabbit or LAL assay).
  • Genotoxicity (In Vitro Mouse Lymphoma Assay): In vitro cell assay.
  • Genotoxicity (Bacterial Mutagenicity Test - Ames Assay): In vitro bacterial assay.
  • Implantation (Subcutaneous Implantation in Rats): Rats. Number not specified.
  • Subchronic/Chronic Toxicity (Subcutaneous Implantation in Rats): Rats. Number not specified.
• Animal Studies (in vivo stability and local tissue response):
  • Rabbit intra-oral model: Rabbit. Number not specified.
  • Rat subcutaneous model: Rat. Number not specified.
• Viral Inactivation Studies: Not specified.

Data Provenance: The studies are non-clinical (laboratory and animal studies), so geographical provenance is not typically specified in the same way as human clinical data. The studies were performed to meet FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards, indicating international (ISO) and U.S. (FDA) regulatory guidelines. All studies appear to be prospective as they were specifically conducted for this submission.

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

This type of information is not applicable to the non-clinical, non-human studies presented. Ground truth for the animal and in vitro tests would be established by the scientific methods and observations within the laboratory, not by expert consensus on interpretations of qualitative clinical data.

4. Adjudication Method for the Test Set

Not applicable as it's not a human clinical study requiring adjudication of expert interpretations.

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 approval involving a physical implantable membrane, not an AI or imaging diagnostic device.

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

Not applicable, as it's not an AI or algorithm-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical studies described, the "ground truth" is based on:

• Laboratory measurements and assays: For physical, chemical, and in vitro biological properties (e.g., cytotoxicity, genotoxicity, permeability, thickness).
• Histopathological examination and observation: For results from animal implantation studies (e.g., tissue reaction, resorption characteristics).
• Validated test methods: Adherence to standards like ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in the context of this traditional medical device submission, as it's not an AI/machine learning model.

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

Not applicable.

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Collagen Dental Membrane - Conformable PP is intended for use in oral surgical procedures as a resorbable membrane material for use in:

• Simultaneous use of GBR-membrane and implants
• Augmentation around implants placed in immediate extraction sockets o
• Augmentation around implants in delayed extraction sockets ●
• Localized ridge augmentation for later implantation
• Alveolar ridge reconstruction for prosthetic treatment ●
• Filling of bone defects after root resection, cystectomy or removal of retained teeth
• Guided bone regeneration in dehiscence defects and ●
• Guided tissue regeneration procedures in periodontal defects. 0

Collagen Dental Membrane - Conformable PP is a white, nonfriable, resorbable, single layered, conformable collagen membrane matrix manufactured from purified porcine peritoneum. Collagen Dental Membrane - Conformable PP is sterilized by gamma irradiation and is supplied sterile, non-pyrogenic and for single use only.

The collagen dental membrane has a thickness of approximately 0.1 to 0.8 mm and is available in the following sizes 12 x 25 mm. 15 x 20 mm, 25 x 25 mm, 20 x 30 mm, and 30 x 40 mm.

The provided document describes a 510(k) premarket notification for a medical device called "Collagen Dental Membrane - Conformable PP". The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices, not typically to prove device performance against specific acceptance criteria in a clinical setting.

Therefore, the document does not contain information on acceptance criteria in the sense of predefined numerical thresholds for clinical performance metrics, nor does it describe a study specifically designed to establish such performance. Instead, it relies on demonstrating equivalence through non-clinical (bench and animal) testing and the existing clinical history of its predicate devices.

However, I can extract the information on the non-clinical tests performed. Please note that "acceptance criteria" here refers to the expected outcome of these non-clinical tests (e.g., non-cytotoxic, non-mutagenic), rather than clinical performance metrics.

Here is the information based on the document:

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

Regarding the other requested information:

2. Sample size used for the test set and the data provenance:

   • Biocompatibility Testing: The "sample size" here refers to the number of animals or cells used in the specific tests.
     • Cytotoxicity: Not specified (in vitro cell culture).
     • Sensitization: Guinea Pig (number not specified).
     • Intracutaneous Reactivity: Rabbits (number not specified).
     • Acute Systemic Toxicity: Mice (number not specified).
     • Genotoxicity: Bacterial cultures (Salmonella typhimurium and Escherichia coli) and Mouse Lymphoma cells.
     • Pyrogenicity: Rabbits (number not specified).
     • Muscle Implantation: Rabbits (number not specified).
     • Subchronic Toxicity: Rat (number not specified).
   • In vitro product characterization: Not applicable, as these are bench tests on device samples.
   • In vivo animal studies: Rabbit intraoral model and rat subcutaneous model (number of animals not specified).
   • Data Provenance: The studies are non-clinical (in vitro and animal studies) performed to support regulatory submission. The country of origin of the data is not specified but is implicitly from testing laboratories. These are prospective tests designed to evaluate the safety and characteristics of the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are non-clinical studies. "Ground truth" in this context would be the objective results of the validated test methods, not expert consensus on interpretations of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers. These are non-clinical, objective laboratory tests.

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 document pertains to a resorbable collagen dental membrane, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical dental membrane, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" is established by the defined and validated methodologies of the respective ISO 10993 standards, USP standards, or specific test protocols (e.g., observation of cell lysis for cytotoxicity, measurement of immune response for sensitization, histological examination for implantation studies).

8. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable, for the same reason as above.

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Collagen Dental Membrane V is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Collagen Dental Membrane V is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from porcine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane V is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

The provided text is related to a 510(k) premarket notification for a medical device called "Collagen Dental Membrane V." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through clinical studies in the way a new drug or novel high-risk device might. The information requested aligns with the evaluation of AI/ML-driven medical devices, which often involve performance metrics, ground truth establishment, and clinical study designs.

However, the provided document does not contain the information requested for AI/ML device studies. This 510(k) summary focuses on the safety and substantial equivalence of a resorbable collagen membrane to existing predicate devices based on in vitro and animal studies, not on the performance of a diagnostic or assistive AI system.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study sizes, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device, as this information is not present in the provided context.

The document indicates:

• Safety Evaluation: Collagen Dental Membrane V was evaluated in various in vitro and in vivo tests to assess its safety/biocompatibility. It passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing.
• Substantial Equivalence: The device is deemed "substantially equivalent" to predicate devices (Collagen Dental Membrane IV and Bio-Gide™ Resorbable Bilayer Membrane) based on similar intended use, form, animal source, sizes, thickness, physical integrity, permeability, and conformability, as well as the safety evaluation.

There is no mention of:

• Acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.)
• A "study" in the sense of a clinical trial proving a device meets specific performance criteria against a ground truth.
• Any sample sizes for test or training sets, as it's not an AI/ML product.
• Expert involvement for ground truth establishment.
• Adjudication methods.
• MRMC studies or human-in-the-loop performance.
• Stand-alone algorithm performance.
• Specific types of ground truth (pathology, outcomes data).

In summary, the provided text describes a submission for a traditional medical device (a resorbable collagen membrane) demonstrating safety and substantial equivalence to existing devices, not an AI/ML-driven device with performance criteria against a ground truth.

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The Kensey Nash P1076 Collagen Dental Membrane is indicated for:

• Simultaneous use of GBR-membrane and implants.
• Augmentation around implants placed in immediate extraction sites.
• Augmentation around implants placed in delayed extraction sockets.
• Localized ridge augmentation for later implantation.
• Alveolar ridge reconstruction for prosthetic treatment.
• Filling of bone defects after root resection, cystectomy, removal of retained teeth.
• Guided bone regeneration in dehiscence defects.
• Guided tissue regeneration procedures in periodontal defects

The Kensey Nash (KN) P1076 Collagen Dental Membrane is a translucent, resorbable, rectangular collagen membrane sheet derived from bovine tissue. The KN P1076 Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.

The provided text is a 510(k) summary for the Kensey Nash P1076 Collagen Dental Membrane, a medical device submission to the FDA. It does not contain any information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, or study methodologies typically associated with proving a device meets specific performance criteria.

The document primarily focuses on:

• Device Description: What the Kensey Nash P1076 Collagen Dental Membrane is (translucent, resorbable, rectangular collagen membrane sheet from bovine tissue, single-use, sterilized by Ethylene Oxide).
• Intended Use/Indications For Use: The specific dental procedures for which the membrane is intended (e.g., GBR with implants, augmentation around implants, localized ridge augmentation, filling bone defects, guided bone and tissue regeneration).
• Predicate Devices: Kensey Nash compares its device to Geistlich Pharma AG's Bio-Gide (K050466) and Collagen Matrix, Inc.'s Collagen Dental Membrane - Conformable II (K062881).
• Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document states: "Performance Testing has confirmed that the Kensey Nash P1076 Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k)."

Key Missing Information:

The document claims that "Performance Testing has confirmed...substantial equivalence" but does not provide any details about this performance testing. Therefore, I cannot extract the information required to answer your prompt, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance for a test set.
• Number/qualifications of experts, adjudication methods for ground truth.
• Results of any Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
• Type of ground truth used.
• Sample size for training set or how its ground truth was established.

Conclusion:

Based solely on the provided text, it is impossible to describe the acceptance criteria and the study that proves the device meets them because these specifics are not detailed in the 510(k) summary provided. The summary asserts that performance testing was done to demonstrate substantial equivalence, but it does not present the results or methodology of that testing.

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The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for:

• . Simultaneous use of Guided Bone Regeneration (GBR)-membrane and implants.
• Augmentation around implants placed in immediate extraction sites. .
• . Augmentation around implants placed in delayed extraction sockets.
• Localized ridge augmentation for later implantation. .
• . Alveolar ridge reconstruction for prosthetic treatment.
• Filling of bone defects after root resection, cystectomy, removal of retained teeth. .
• Guided bone regeneration in dehiscence defects. .
• . Guided tissue regeneration procedures in periodontal defects

The Kensey Nash (KN) Fibrillar Collagen Dental Membrane is a translucent, resorbable, non-friable, rectangular collagen membrane sheet derived from bovine tissue. The KN Fibrillar Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.

The provided text is a 510(k) summary for the Kensey Nash Fibrillar Collagen Dental Membrane. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about specific acceptance criteria or a study demonstrating the device meets those criteria.

The document states: "Performance Testing has confirmed that the Kensey Nash Fibrillar Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k)." This is a general statement and does not provide details of acceptance criteria or performance results.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details because this information is not present in the provided text.

The closest information provided is the list of predicate devices, implying that the new device's performance is compared to theirs for substantial equivalence, but the specific metrics and comparison results are absent.

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Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Collagen Dental Membrane IV is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from bovine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane IV is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

The provided text describes a 510(k) summary for the "Collagen Dental Membrane IV" device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria based on performance studies. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not specified. The document mentions "in vitro and in vivo tests," but does not detail the specific sample sizes used within these tests.
• Data provenance: "in vitro and in vivo tests." No specific country of origin or whether the data was retrospective or prospective is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. The document does not describe the use of experts to establish ground truth for performance metrics in a clinical study. The evaluation focused on safety and comparability to predicates.

4. Adjudication method for the test set:

• Not applicable/Not specified. This is not a study requiring adjudication of expert interpretations.

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 resorbable membrane, not an AI-powered diagnostic tool, so 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 a medical device (collagen membrane), not an algorithm.

7. The type of ground truth used:

• For safety/biocompatibility: The ground truth was established by adherence to recognized standards (FDA Blue Book Memorandum G95-1 and ISO 10993-1).
• For technical characteristics comparison: The "ground truth" was a comparison to the established characteristics of the predicate devices. The document implies that the predicate devices' characteristics serve as the benchmark for "similarity."

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense. The "training" or development would involve laboratory and animal studies, but not a "training set" of data for an algorithm.

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

• Not applicable. As above, there is no "training set" for an algorithm. The development and verification process involved established laboratory and animal testing methods to ensure the materials met safety and performance criteria, which could be considered forms of "ground truth" for the material properties.

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Collagen Dental Membrane III is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery.

Collagen Dental Membrane III is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.

Collagen Dental Membrane III is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane III is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

This submission describes a medical device, Collagen Dental Membrane III, intended for use in dental surgery procedures. It is a resorbable membrane matrix designed to aid in wound healing after dental implant, bone defect, or ridge reconstruction.

Here’s an analysis of the provided text based on your request, highlighting that this is not an AI/ML device and therefore many of your questions are not applicable:

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

2. Sample size used for the test set and the data provenance

This is not an AI/ML device. Therefore, the concepts of "test set," "sample size," and "data provenance" as they relate to AI model evaluation are not applicable here. The evaluation involved biocompatibility testing and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not an AI/ML device. "Ground truth" in the context of expert review for AI is not relevant. The evaluation of this device is based on standardized biocompatibility testing protocols and material characterization, not expert human interpretation of data for AI model training or validation.

4. Adjudication method for the test set

This is not an AI/ML device. "Adjudication method" as it applies to resolving discrepancies in expert labeling for AI models is not applicable. The device's safety and equivalence were determined through established regulatory testing and comparison methods.

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 is not an AI/ML device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not conducted and is not relevant to this type of medical device submission.

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

This is not an AI/ML device. No algorithm or standalone performance evaluation was conducted because it is a physical medical device (collagen membrane), not a software or AI product.

7. The type of ground truth used

For this device, the "ground truth" aligns with established scientific and regulatory standards for medical devices:

• Biocompatibility: Determined by adherence to FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards (e.g., cytotoxicity, sensitization, irritation tests). The "ground truth" is that the device, when subjected to these tests, does not elicit unacceptable biological responses.
• Substantial Equivalence: Determined by demonstrating that the device has the same intended use and similar technological characteristics (material, form, sizes, thickness, physical integrity, permeability, conformability) to a legally marketed predicate device. The "ground truth" for equivalence is the predicate device's established safety and effectiveness profile.

8. The sample size for the training set

This is not an AI/ML device. Therefore, there is no "training set" in the context of machine learning.

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

This is not an AI/ML device. There is no training set for this type of device.

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Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.

The Collagen Dental Membrane is a resorbable, type I collagen matrix of defined geometry, in vivo stability, permeability and mechanical strength for use as a material to aid in wound healing in bone repair, ridge augmentation and dental implant procedures.

The device is provided in two sizes 20 mm x 30 mm x 40 mm. The device can be easily trimmed for a final fit during surgery to the appropriate size and shape required for the defect to be treated.

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

2. Sample size used for the test set and the data provenance:
   For the "Summary of In Vivo Resorption Studies," the study was conducted using a "rat subcutaneous implantation model." The specific number of rats or samples is not provided, nor is the country of origin. This was an animal study.
   For the "Summary of Effectiveness Data" (Animal Data and Clinical Data), the information is derived from a "comprehensive literature search" and "results from human studies from the literature." No specific sample sizes for a single test set are provided, as this refers to aggregated literature. The provenance is from published animal and human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The effectiveness data comes from a literature review of existing studies, not from a new test set with expert-established ground truth. Biocompatibility and in vivo resorption studies would typically involve laboratory analysis and histopathology, but no information on specific experts or their qualifications is provided in this summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. As noted above, the effectiveness data relies on a literature review, and the other studies (biocompatibility, in vivo resorption) are laboratory-based, not expert adjudication for a test set in the described manner.

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 dental membrane, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical material (collagen dental membrane), not an algorithm or AI system.

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

   • For "Summary of In Vivo Resorption Studies": The ground truth for resorption time would likely be established through histological examination of explanted tissues, potentially involving pathology.
   • For "Summary of Effectiveness Data" (Animal and Clinical): The ground truth is derived from the established scientific literature on Guided Bone Regeneration (GBR), which would typically involve histological evidence of bone formation, clinical outcomes (e.g., implant integration, bone fill), and expert interpretation from those studies.

8. The sample size for the training set:
   Not applicable. This submission describes a physical medical device, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established:
   Not applicable, as this device does not involve a machine learning model with a training set.

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