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

Lumina-PTFE Titanium is a synthetic, biocompatible, single-use, sterile polymeric barrier composed of a 100% polytetrafluoroethylene (PTFE) reinforced by a titanium structure. The titanium frame is embedded between two layers of PTFE. This medical device is 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. The PTFE membranes are designed to maintain space and conform to tissue contours. Lumina-PTFE Titanium is provided in thicknesses of 0,25mm and different sizes.

The provided text is a 510(k) premarket notification for a medical device called "Lumina-PTFE Titanium." This document does not describe an AI or software device that requires acceptance criteria related to a study proving performance against a ground truth, or an MRMC study.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Cytoplast™ Titanium-Reinforced PTFE Membranes). This is achieved by comparing the device's technological characteristics and presenting non-clinical performance data (e.g., biocompatibility tests, sterilization validation, material property tests like absorption, wettability, tension break, elasticity, suture pullout strength, and peel resistance).

Therefore, I cannot provide the requested information about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance), and ground truth establishment, as these are not relevant to the type of device and submission described in the input.

The entire submission is dedicated to proving that "Lumina-PTFE Titanium" shares the same indications for use, principle of operation, design, composition, and other technical characteristics as its predicate, and that any differences do not raise new questions of safety or effectiveness. No AI or algorithm performance metrics are discussed.

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OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.

OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes.

This is a 510(k) summary for a medical device called OpenTex, a non-resorbable PTFE membrane for guided tissue regeneration in periodontal defects. The information provided is for regulatory clearance and does not involve AI or algorithms with human-in-the-loop performance. Therefore, many of the requested fields are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

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InnoGenic™ Non-resorbable membrane is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "InnoGenic™ Non-resorbable Membrane". This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI/ML powered medical device.

The document states that the device is a "temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites." It is a Class II device (Bone Grafting Material, 21 CFR 872.3930).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

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Bio-MEM Ti Reinforced membranes are an implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Bio-MEM Ti Reinforced membranes are intended to be submerged and clinically implanted more than 30 days and no longer than 6 months.

Bio-MEM Ti Reinforced membranes are non-resorbable membranes available as Tireinforced configured of a highly shapeable Ti (Reinforced only) enveloped by an embossed polytetrafluoroethylene (PTFE) membrane. Extensive documentation demonstrates tissue compatibility of PTFE. Bio-MEM Ti Reinforced membranes are designed to avoid ingrowth of gingival soft tissue into bony defects, in order to facilitate the neovascularization and bone formation during the repair process of the defect. Bio-MEM Ti Reinforced membranes are provided STERILE and in different anatomical shapes and sizes. The titanium reinforcement is intended for space creating and shapemaintaining which minimize movements and subsequent exposure during the regenerative healing.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-MEM Ti Reinforced Membrane.

Note: The provided text is a 510(k) summary for a medical device (Bio-MEM Ti Reinforced Membrane). 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting acceptance criteria and studies in the traditional scientific sense for a novel AI/software device. Therefore, the information below will reflect that context. The questions asked are more aligned with AI device studies, and the response will clarify what information is available given the document type.

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" and "reported device performance" as one might see for a diagnostic AI algorithm are not explicitly stated in this 510(k) summary. Instead, the document focuses on demonstrating that the Bio-MEM Ti Reinforced Membrane is substantially equivalent to its predicate devices based on design, materials, technological characteristics, and performance testing against recognized standards.

The performance testing sections describe the studies undertaken to ensure the device's safety and functionality, which implicitly means the device met the requirements of these tests.

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

The document describes material and mechanical tests, and biocompatibility studies. These types of tests do not typically use "test sets" of patient data in the same way an AI algorithm would.

• Sample Size for Test Set: Not applicable in the context of human patient data for algorithm evaluation. For the bench and in-vitro/in-vivo biocompatibility tests, specific sample sizes are not detailed in this summary document, but the fact that the tests were conducted according to ISO/ASTM/USP standards implies appropriate sample sizes were used for those specific test methods.
• Data Provenance: Not applicable. These tests were likely performed in a laboratory setting, not with patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for these types of device performance tests (e.g., sterility, material strength, biocompatibility) is established by adherence to validated international standards and the results of laboratory measurements, not by expert human interpretation of medical images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. This concept belongs to the evaluation of algorithms where human assessment of data needs to be considered. For a physical device like this, performance is measured against established scientific and engineering standards.

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

No. An MRMC study is a clinical study design used to compare the performance of different diagnostic methods (e.g., human readers with and without AI assistance). This 510(k) summary is for a physical medical implant (a membrane) and focuses on demonstrating its safety and substantial equivalence, not its diagnostic accuracy or the improvement of human performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is not an algorithm, so "standalone performance" in that context is not applicable. Its performance is measured by its material properties, biological interactions, and mechanical integrity.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests is either:

• Physical/Chemical Standards: (e.g., strength measurements in Bend and Delamination testing, density, thickness).
• Biological Standards: (e.g., absence of cytotoxicity, irritation, sensitization, genotoxicity, pyrogenicity as defined by ISO 10993 and USP standards).
• Microbiological Standards: (e.g., sterility per ISO 11135).

Essentially, the ground truth is adherence to internationally recognized and validated scientific and engineering standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

Not applicable. As there is no AI algorithm and no training set, this question is not relevant to the Bio-MEM Ti Reinforced Membrane.

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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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The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (nonresorbable) for use as a space-making barrier in the treatment of periodontal defects.

The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is composed of microporous PTFE material. It has a nominal thickness of 250 microns and is supplied in two sizes (25mm x 30mm and 12mm x 24mm). The membranes are single use and are supplied in sterile sealed pouches.

The provided document is a 510(k) Premarket Notification for a medical device called the Salvin CytoSurg™ Non-Resorbable PTFE Membrane. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria in the context of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML device cannot be extracted from this document.

However, I can extract the performance data and the conclusion related to the device's substantial equivalence to its predicate, as presented in the document.

Acceptance Criteria and Reported Device Performance (as related to substantial equivalence):

Since this is not an AI/ML device, the following information is not applicable and cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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Cytoflex® Tef-Guard® Ti-Enforced membrane is a temporarily, non-resorbable, implantable material for use as a space-making barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle.

Cytoflex® Tef-Guard® Ti-Enforced membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a passive, non-load bearing material with a titanium frame enclosed within two exterior layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft migration during wound healing. The membranes are designed to reduce the migration and establishment of gingival tissue derived cells into bony defects thus providing a more favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. The membranes are intended to be submerged and implanted for more than 30 days and up to 6 months. The membrane is supplied sterile and available in a variety of shapes and sizes for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cytoflex® Tef-Guard® Ti-Enforced Membrane:

Important Note: The provided document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical efficacy testing. Therefore, many of the typical elements of a study proving a device meets acceptance criteria (like human reader studies, ground truth establishment for a test set, etc.) are not applicable in this context. The acceptance criteria here largely revolve around device performance characteristics and biocompatibility, demonstrated through non-clinical bench testing.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each test in a table format. Instead, it states that the device "was found to meet the requirements of the pre-defined acceptance criteria" for the listed ISO standards and that "The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance."

However, based on the performance testing section and the comparison table with predicate devices, we can infer the types of criteria and the reported performance:

• Density: Not to exceed a certain deviation from predicate (e.g., within 0.5 g/dm² difference).
• Material Composition: ePTFE with Titanium frame.
• Design: Multi-layer, non-resorbable, space-making barrier, trimmable, flexible. | - Thickness: 0.25mm (Predicate 1: 0.23mm; Predicate 2: 0.3mm). Considered "Substantially Equivalent."
• Density: 3.5 g/dm² (Predicate 1: 4.0 g/dm²; Predicate 2: 3.5 g/dm²). Considered "Substantially Equivalent."
• Material Composition: ePTFE membranes reinforced with a Titanium frame. Considered "Substantially Equivalent."
• Design: A variety of configurations, trimmable and shaped to fit bony defect. Considered "Substantially Equivalent." |
  | Functional Performance | - Tensile Loading: Performance similar to predicate.
• Bending: Performance similar to predicate.
• Flexibility: Performance similar to predicate.
• Delaminating Potential: Performance similar to predicate. | "The test results demonstrate that the subject device is substantially equivalent to the primary predicate device in functional performance." (No specific quantitative values provided for the subject or predicate, just a statement of equivalence). |
  | Biocompatibility | - Cytotoxicity: No evidence of cytotoxicity (ISO 10993-5).
• Local Effects after Implantation: No adverse local effects (ISO 10993-6).
• Irritation & Skin Sensitization: No irritation or sensitization (ISO 10993-10).
• Systemic Toxicity: No systemic toxicity (ISO 10993-11). | "Found to meet the requirements of the pre-defined acceptance criteria" for ISO 10993-5, -6, -10, -11. "Biocompatible: Yes." |
  | Sterility | - Sterility Assurance Level (SAL): SAL

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An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.

The Neoss Ti Reinforced Membrane a multi-layer non-resorbable dental membrane intended to be surgically placed beneath the muco-periosteum to aid in regenerative healing in 1) bone or 2) bone/periodontal ligament defects of the oral cavity. The Neoss Ti Reinforced Membrane is composed of two layers of PTFE membrane material enclosing a Titanium(Ti) mesh. The Neoss Ti Reinforced Membrane is a passive, non-load bearing material. The small pores of the PTFE membrane material, allows passage of fluid and vapor; as well as a controlled cellular ingrowth for stability and a barrier for soft tissue penetration. The Ti mesh is unalloyed surgical grade Titanium ISO 5832-2 Grade 2. The titanium mesh reinforcement is intended for space creating and shape-maintaining which minimizes movements and subsequent exposure while implanted. Neoss Ti Reinforced Membrane is provided pre-shaped in a variety of shapes and sizes detailed below. The device is supplied sterile and single use.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Neoss Ti Reinforced Membrane." It is a regulatory approval document and not a study report that details acceptance criteria and device performance in a clinical context.

Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from this document.

The document states:

• "Clinical Testing: Clinical data was not required to establish the substantial equivalence of the Neoss Ti Reinforced Membrane." This explicitly indicates that a clinical study, with its associated methodologies for acceptance criteria and performance measurement, was not performed or submitted as part of this specific FDA cleared.

The "Performance Testing" section mentions tests conducted according to ISO and ASTM standards (e.g., burst strength, bend testing, biocompatibility). However, these are engineering and material property tests to ensure the device meets specified quality and safety characteristics, not clinical performance acceptance criteria. The document lists the standards applied, but does not provide the specific acceptance criteria values or the reported performance values of the Neoss Ti Reinforced Membrane against those criteria. It only states that these tests were done "in order to confirm the strength, integrity and functionality of the device."

The document focuses on establishing "substantial equivalence" to predicate devices based on indications for use, technological characteristics, and material composition, rather than presenting a standalone study with defined acceptance criteria and performance results in a table.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance (as no clinical test set was described).
3. Number of experts or their qualifications (as no ground truth establishment for a clinical test set was described).
4. Adjudication method (as no clinical test set was described).
5. MRMC comparative effectiveness study (as no human reader study was described).
6. Standalone performance (as it refers to clinical performance, which was not assessed in a study described here).
7. Type of ground truth used (as no clinical ground truth was established).
8. Sample size for the training set (as this is not a machine learning device).
9. How ground truth for the training set was established (as this is not a machine learning device).

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GBR Configurations: To aid in bone regeneration and augmentation in oral surgery for: Extraction socket site preservation; Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desire; Ridge augmentation; Sinus elevation; Stable barrier for the containment of bone grafting materials. GTR Configurations: To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planning for: Class II furcations; intrabony defects; recession type defects.

The GUIDOR® Bioresorbable Matrix Barrier is a two-layered (sandwich) structure with spacers between the layers that provide stability to the matrix and maintain an adequate space to aid in tissue regeneration and prevention of epithelial downgrowth. The GUIDOR® Matrix is bioresorbable to allow for singlestep surgery, eliminating the need for a second surgery to remove the matrix.

1. Acceptance Criteria and Reported Device Performance:

Study Information:

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

   • The document does not explicitly state a specific "test set" sample size or its country of origin.
   • The clinical evidence provided is based on "retrospective clinical data and human studies reported in the literature." This suggests the data is retrospective, but the origin country is not specified.

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

   • Not applicable. The study relies on "retrospective clinical data and human studies reported in the literature" rather than a specific expert-adjudicated test set for this 510(k) submission. No information is provided about the number or qualifications of experts involved in the original studies forming the literature review.

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

   • Not applicable. No explicit adjudication method is mentioned for a test set. The submission relies on a literature review.

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 bioresorbable matrix barrier, not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

   • Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

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

   • The "ground truth" is implicitly derived from the established clinical outcomes and efficacy reported in the existing "retrospective clinical data and human studies reported in the literature" for both synthetic resorbable membranes and resorbable collagen membranes. This effectively means outcomes data from previously conducted clinical studies.

8. The sample size for the training set:

   • Not applicable. This submission does not describe an AI/machine learning model with a distinct "training set." The evidence for substantial equivalence is based on existing published clinical literature.

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

   • Not applicable, as there is no described training set for an algorithm in this submission.

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