(157 days)
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
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Cytotoxic measurements results equal to or less than the predicate data. | Non-cytotoxic |
| Acute Systemic Toxicity | Acute Systemic Toxicity results equal to or less than the predicate data. | Non-toxic |
| SQ Implantation (4 Weeks) - Rabbits | SQ Implantation results equal to or less than the predicate data. | Slight Irritant |
| Gelation time | 20-50 seconds | Passed |
| In-vitro water uptake of the gelled product | Less than 20%wt within 4 hours after gelation | Passed |
| In-vitro degradation pattern and time | Following a defined degradation kinetics ending in complete disintegration of the MembraGel | Passed |
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.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.