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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:

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

The document does not specify sample sizes for the performance (tensile loading, bending, flexibility, delamination) or biocompatibility tests. These tests are typically conducted in a laboratory setting on a representative number of device samples.

• Provenance: This is a non-clinical 510(k) submission. The data provenance would be from laboratory bench testing and materials characterization, not from patient data or clinical studies.

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

This is not applicable as there was no test set requiring expert interpretation or ground truth establishment for clinical performance. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the acceptance limits defined by the relevant ISO standards and predicate device performance.

4. Adjudication Method for the Test Set

This is not applicable as there was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. No MRMC clinical study was performed or required for this 510(k) submission. The device is a physical implant, not an imaging or diagnostic AI device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used

For the non-clinical testing:

• Bench Test Results: The "ground truth" for functional performance tests (tensile, bending, flexibility, delamination) was derived from direct comparison to the performance of the chosen predicate device, assessed through quantitative measurements. The acceptance criterion was "substantially equivalent" performance to the predicate.
• ISO Standard Requirements: For biocompatibility and sterilization, the "ground truth" was established by the requirements and limits defined within the specified ISO standards (e.g., no cytotoxicity detected according to ISO 10993-5).

8. Sample Size for the Training Set

This is not applicable. There was no "training set" in the context of an AI/ML algorithm. The device is a manufactured physical product.

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

This is not applicable. There was no "training set" for this device.

Summary of Approach:

The K151344 submission for the Cytoflex® Tef-Guard® Ti-Enforced Membrane relied on demonstrating substantial equivalence to existing predicate devices. This was achieved primarily through:

• Comparison of Device Characteristics: Showing similar materials, design, indications for use, thickness, density, and sterility to the predicate devices.
• Non-Clinical Performance Testing: Bench testing for functional performance (tensile loading, bending, flexibility, delamination) was conducted, and the results confirmed that the subject device performed "substantially equivalent" to one of the predicate devices.
• Biocompatibility and Sterilization Testing: Meeting the requirements of relevant ISO standards for biocompatibility (cytotoxicity, local effects, irritation, systemic toxicity) and sterilization (EtO sterilization, residuals).

Clinical data was specifically stated as "not required to establish the substantial equivalence." This means the FDA accepted the non-clinical data as sufficient for demonstrating safety and effectiveness comparable to the legally marketed predicate devices.

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CytoFlex® Resorb membranes are intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and regeneration of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.

CytoFlex® Resorb barriers are made from polyglycolide, polylactide and poly(glycolide-co-lactide) copolymer. CytoFlex® Resorb is a resorbable barrier membrane and is supplied in a variety of shapes and sizes in sealed pouches. CytoFlex® Resorb membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

The provided text describes a 510(k) summary for the CytoFlex® Resorb device, which is an absorbable barrier membrane. However, it does not contain information about any specific study or acceptance criteria related to device performance.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification.
• Predicate Devices: Listing of similar devices already on the market.
• Device Description: Material composition (polyglycolide, polylactide, poly(glycolide-co-lactide) copolymer), form factor (various shapes and sizes in sealed pouches).
• Intended Use/Indications for Use: Applications in periodontal defects, maxillofacial guided tissue regeneration, and as a grafting material containment matrix.
• FDA Communication: A letter from the FDA indicating that the device has been found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized 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
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This type of 510(k) submission, especially for a Class II device seeking substantial equivalence, often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical performance studies with acceptance criteria in the manner you've described for AI/diagnostic devices. The "study" here is essentially the comparison to predicate devices based on material properties, manufacturing, and intended use.

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For use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material.

Cytoflex Mesh is a precision titanium mesh of a specific dimension and pore size. Cytoflex Mesh is supplied in specific sizes and thickness in sealed pouches. Cytoflex Mesh is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

The provided text describes a medical device, the Cytoflex Mesh, and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device.

This document is solely focused on the regulatory clearance process for a predicate device, establishing substantial equivalence based on device description and intended use, rather than a performance study with quantitative acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
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
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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

CytoFlex™ is a non-resorbable barrier membrane that is composed of microporous ePTFE material. The sterile membrane has a nominal thickness of 250 microns and is supplied in a variety of shapes and sizes in sealed pouches. The biocompatibility of ePTFE has been established through a long history of use in a variety of implant applications. CytoFlex™ membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

The provided document is a 510(k) summary for the Unicare Biomedical CytoFlex™ ePTFE barrier membrane, which is a medical device. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with acceptance criteria for an AI/algorithm-based device.

Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not available in the provided text, as it describes a physical barrier membrane, not an algorithmic or AI device.

Let's break down what can be extracted and what cannot:

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

• Not Applicable. The document describes a physical medical device (ePTFE barrier membrane) and its substantial equivalence to predicate devices, not an AI or algorithmic device with performance metrics like sensitivity, specificity, etc. The "acceptance criteria" here would be meeting the requirements for substantial equivalence to predicates, which is a regulatory assessment, not a device performance metric.

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

• Not Available. This information would be relevant for a study evaluating an AI/algorithmic device. The 510(k) summary for a physical device does not typically include "test datasets" in this context.

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)

• Not Applicable. Ground truth for data is not relevant for a physical barrier membrane in this type of submission.

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

• Not Applicable. See point 3.

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 physical product, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical product, not an algorithm.

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

• Not Applicable. Ground truth, in the context of AI/algorithmic devices, is not a concept applied to this type of physical medical device submission.

8. The sample size for the training set

• Not Applicable. No training set exists for this physical device.

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

• Not Applicable. No training set or ground truth for a training set exists for this physical device.

Summary of Relevant Information from the Document:

• Device Name: CytoFlex™ ePTFE barrier membrane
• Device Description: "a non-resorbable barrier membrane that is composed of microporous ePTFE material. The sterile membrane has a nominal thickness of 250 microns and is supplied in a variety of shapes and sizes in sealed pouches."
• Indication for Use: "A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects."
• Proof of Meeting Regulatory Requirements (not "acceptance criteria" in the AI sense): The device was found to be "substantially equivalent" to legally marketed predicate devices (Imtec BioBarrier membrane, Osteogenics Cytoplast GBR, Gore-tex Regenerative Material, TefGen-FD). "The biocompatibility of ePTFE has been established through a long history of use in a variety of implant applications. CytoFlex™ membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices."

The 510(k) process for a Class II device like this primarily relies on demonstrating substantial equivalence to existing devices rather than new clinical trials with predefined performance metrics and acceptance criteria as would be expected for a novel AI algorithm.

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