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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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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 MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.

MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.

The provided document is a 510(k) summary for the MEDPOR® CONTAIN™ Implant. It describes the device, its intended use, technological characteristics, and compares it to predicate devices to establish substantial equivalence.

Crucially, this document is a premarket notification for a medical device and does not contain a study or data proving the device meets acceptance criteria. Instead, it is a submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, many of the requested sections, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, and details of comparative effectiveness studies (MRMC or standalone), cannot be extracted from this document, as they are not present.

However, I can provide information based on what is available regarding the comparison to predicate devices, which is the basis for its clearance.

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

This document does not specify "acceptance criteria" in the typical sense of a performance study with numerical targets and results. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, material, design, sterilization, and biocompatibility.

The "reported device performance" in this context is implicitly the assertion that the MEDPOR CONTAIN Implant performs similarly to its predicates due to shared characteristics.

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

Not applicable. This document is a 510(k) premarket notification based on substantial equivalence to existing predicate devices, not a clinical study report with a test set. There are no "test sets" or "data provenance" details for a performance study in this submission.

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

Not applicable. As no performance study with a test set is reported, there is no "ground truth" established by experts within this document. The assessment is regulatory by the FDA based on the submission.

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

Not applicable. No test set or performance data is presented, so no adjudication method is relevant here.

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. A MRMC comparative effectiveness study is not discussed. This device is a passive implant, not an AI-powered diagnostic tool.

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

Not applicable. This device is a medical implant, not an algorithm, so this type of study is not relevant.

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

Not applicable. No ground truth data from a performance study is utilized in this 510(k) summary. The "ground truth" for the FDA's decision is the established safety and effectiveness of the predicate devices to which the new device is compared.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for a machine learning model, there is no associated ground truth establishment method.

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