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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 regeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. Because 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, degradable barrier membrane for single patient use. It is composed of two liquid poly(ethylene glycol) (PEG) compounds forming a hydrogel upon mixing. Straumann MembraGel is applied as a viscous liquid and gels on the application site within approximately 20 to 50 seconds. Straumann MembraGel acts as a barrier that inhibits non-osteogenic soft tissue cells of the overlying soft tissue from entering the defect site thereby supporting undisturbed regeneration of alveolar bone. Degradation of Straumann MembraGel by hydrolysis starts during normal wound healing. Straumann MembraGel must be stored refrigerated between 2-8°C (36-46°F). The application volume of Straumann MembraGel is 0.8 ml for approximately 5-7cm² coverage. The Straumann MembraGel kit contains: Two glass syringes each filled with a PEG component (PEG A and PEG B) mounted in a plastic holder. Two plastic syringes each filled with an activator (Activator A and Activator B) in a plastic holder. One applicator tip (a static mixer connected to an adapter). All components are delivered sterile and must be used immediately after opening of the blister packaging in an aseptic surgical environment.

The Straumann MembraGel is a sterile, synthetic, degradable barrier membrane intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the specific tests performed (e.g., number of cytotoxicity tests, number of animals for SQ implantation, number of samples for gelation time).

The data provenance is not explicitly mentioned as country of origin, but the testing was performed to support a 510(k) submission to the US FDA, implying compliance with US regulatory standards. The clinical study type is not specified (e.g., retrospective or prospective), but based on the nature of the tests (biocompatibility, in-vitro degradation), they are laboratory-based tests rather than clinical trials with human subjects. The SQ Implantation was performed on rabbits, which is an animal study.

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

This section is not applicable as the provided document describes testing for a medical device (a synthetic barrier membrane) and not an AI/software device that would require expert-established ground truth from medical images or clinical data. The "ground truth" here refers to established scientific and regulatory standards for device performance and safety.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like '2+1' or '3+1' are typically used in clinical trials or studies involving human expert review, especially for diagnostic or prognostic AI systems. Here, the "truth" is determined by measured physical, chemical, and biological properties according to predefined protocols.

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

This section is not applicable. The provided document describes a medical device (bone grafting material), not an AI system or software that would involve human readers or AI assistance.

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

This section is not applicable. The device is a physical medical product, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the Straumann MembraGel is based on:

• Pre-defined specifications/standards: This includes internal specifications for gelation time, water uptake, and degradation kinetics.
• Comparison to predicate device: For biocompatibility tests (cytotoxicity, acute systemic toxicity, SQ implantation), the acceptance criteria specify that results should be "equal to or less than the predicate," meaning the predicate device's established safety profile served as a benchmark.
• Scientific and regulatory guidelines: The biocompatibility tests (cytotoxicity, systemic toxicity, implantation) are standard tests mandated by regulatory bodies like the FDA for medical devices, following established methodologies.

8. The Sample Size for the Training Set

This section is not applicable. The document describes a physical medical device, not a machine learning model or an AI system that would require a "training set."

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

This section is not applicable for the same reasons as point 8.

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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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