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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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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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