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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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Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The provided text is a 510(k) summary for a dental device, the "P.004 RC/NC Gold and Titanium Abutment for Bars." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through clinical or performance studies with detailed metrics.

Therefore, the information required in your request cannot be fully extracted from this document, as it describes a regulatory submission process based on equivalence rather than detailed performance study results.

Here's a breakdown of why and what little can be inferred:

• Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria or detailed performance data (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) in the way a clinical or technical validation study would. The document states, "The proposed abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices." This is the core "proof" presented for regulatory acceptance under the 510(k) pathway.

• Study That Proves the Device Meets Acceptance Criteria: There is no specific study described that "proves" the device meets acceptance criteria in the manner of defining and then testing against specific performance thresholds. The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is typically achieved by comparing technological characteristics, materials, and intended use, often supported by non-clinical bench testing for mechanical properties (though not detailed here), rather than multi-reader studies or ground truth comparisons.

Given these limitations of the provided text, here's what can be answered, and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. This document does not describe a clinical or performance study with a "test set" in the context of AI/diagnostic device validation. It's a regulatory submission based on substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. There is no "ground truth" establishment or expert review detailed in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication method is described.

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

• No. This document does not describe an MRMC study. The device is a physical dental abutment, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable. This is a physical medical device (dental abutment), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. The concept of "ground truth" for comparative performance evaluation is not relevant to this 510(k) submission, which relies on demonstrating equivalence in design, materials, and intended use to predicate devices.

8. The sample size for the training set

• Not Applicable. No training set is described.

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

• Not Applicable. No training set or ground truth establishment is described.

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