Search Results

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.

Ask a specific question about this device