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

The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. The membrane has a nominal thickness of 250 microns. Membranes are supplied sterile in sealed pouches in a variety of shapes and sizes.

The biocompatibility of polytetrafluoroethylene (PTFE) and titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been conducted with this device.

Here's an analysis of the provided text regarding the Cytoplast Regentex Titanium 250 Non-Absorbable Barrier Membrane, presented in the requested format. It's important to note that the provided 510(k) summary focuses heavily on substantial equivalence to predicate devices rather than detailed performance studies with specific acceptance criteria and outcome data. Therefore, many sections will indicate "Not Applicable" or that the information is "Not provided in the document."

1. Acceptance Criteria and Reported Device Performance

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

Not provided in the document. The submission relies on substantial equivalence to predicate devices, rather than a new performance study with a test set.

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

Not applicable, as no new performance study with a test set requiring expert ground truth establishment is described. The device's safety and effectiveness are established through comparison to predicate devices, whose performance would have been established previously.

4. Adjudication method for the test set

Not applicable.

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 barrier membrane, 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 device is a barrier membrane, not an algorithm.

7. The type of ground truth used

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their prior regulatory approvals and clinical use. No new ground truth for a novel device performance study is described.

8. The sample size for the training set

Not applicable. The submission does not describe a training set as it is not an AI/ML device or a device requiring a specific training regimen for its function.

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

Not applicable.

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

The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches.

The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic.

I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study that directly proves the device meets such criteria. The document describes a 510(k) summary for a medical device (Cytoplast™ GBR Non-Absorbable Barrier Membrane) and primarily focuses on comparing it to predicate devices to establish substantial equivalence.

Here's a breakdown of why I cannot fulfill your request with the given input:

• Acceptance Criteria and Device Performance: The document states that the device is "identical in composition, function, and intended use to legally marketed predicate devices" and "performs at least as well." However, it does not provide specific quantitative acceptance criteria (e.g., "device must achieve X % success rate" or "device must have Y MPa tensile strength") or any reported device performance data against such criteria.
• Study Details: There is no mention of any specific study (clinical trial, bench test, in-vitro study) with details about sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods. The comparison is based on the characteristics of the device being similar to already approved predicate devices.
• MRMC, Standalone, Training Set: These concepts are relevant to studies involving AI algorithms or diagnostic devices. The Cytoplast™ GBR is a physical barrier membrane, and the provided document does not indicate any AI component, diagnostic function, or a multireader assessment.

Therefore, I cannot populate the requested table or answer the specific questions about study design, ground truth, or training sets from the information given. The provided text is a summary for a 510(k) submission focused on substantial equivalence to existing devices rather than a detailed report of a performance study with specific acceptance criteria.

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