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Straumann MembraGel is a biodegradable, synthetic, in situ forming hydrogel material. It is intended to aid in the regeneration and integration of oral tissue components in guided bone reqeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets.

Because Straumann MembraGel is not self supporting it must be used in combination with a bone graft material in order to maintain space under the membrane.

Straumann® MembraGel is a sterile, synthetic, biodegradable barrier membrane for single patient use. It is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures.

The provided text is a 510(k) summary for the Straumann® MembraGel device and subsequent FDA correspondence. It does not describe acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., with performance metrics like sensitivity, specificity, or accuracy, or a clinical trial design and results).

Instead, this document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The information provided is primarily about the device itself, its intended use, and its equivalence to other legally marketed devices, rather than a performance study with detailed results against defined acceptance criteria.

Therefore, for your request, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the device's function (e.g., successful regeneration rates, mechanical properties tested against benchmarks) nor does it report device performance against such metrics.
• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment is described.
• Adjudication method for the test set: No test set or adjudication is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a bone grafting material, not an algorithm.
• The type of ground truth used: No ground truth is described.
• The sample size for the training set: No training set is described.
• How the ground truth for the training set was established: No training set or ground truth establishment is described.

The document states: "The proposed Straumann® MembraGel is substantially equivalent to the currently marketed devices. The intended use is the same as the intended uses of the predicate devices. The proposed hydrogel has the similar material composition, basic design and fundamental operating principles to the currently marketed devices." This statement is the core of a 510(k) submission, confirming that the device is similar enough to existing devices that it doesn't require a new, extensive clinical trial to prove safety and effectiveness.

In summary, the provided text describes a regulatory filing for a medical device based on substantial equivalence, not a performance study with acceptance criteria and results for an AI/algorithm-based device.

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