(520 days)
Bio-MEM Ti Reinforced membranes are an implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Bio-MEM Ti Reinforced membranes are intended to be submerged and clinically implanted more than 30 days and no longer than 6 months.
Bio-MEM Ti Reinforced membranes are non-resorbable membranes available as Tireinforced configured of a highly shapeable Ti (Reinforced only) enveloped by an embossed polytetrafluoroethylene (PTFE) membrane. Extensive documentation demonstrates tissue compatibility of PTFE. Bio-MEM Ti Reinforced membranes are designed to avoid ingrowth of gingival soft tissue into bony defects, in order to facilitate the neovascularization and bone formation during the repair process of the defect. Bio-MEM Ti Reinforced membranes are provided STERILE and in different anatomical shapes and sizes. The titanium reinforcement is intended for space creating and shapemaintaining which minimize movements and subsequent exposure during the regenerative healing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-MEM Ti Reinforced Membrane.
Note: The provided text is a 510(k) summary for a medical device (Bio-MEM Ti Reinforced Membrane). 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting acceptance criteria and studies in the traditional scientific sense for a novel AI/software device. Therefore, the information below will reflect that context. The questions asked are more aligned with AI device studies, and the response will clarify what information is available given the document type.
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" and "reported device performance" as one might see for a diagnostic AI algorithm are not explicitly stated in this 510(k) summary. Instead, the document focuses on demonstrating that the Bio-MEM Ti Reinforced Membrane is substantially equivalent to its predicate devices based on design, materials, technological characteristics, and performance testing against recognized standards.
The performance testing sections describe the studies undertaken to ensure the device's safety and functionality, which implicitly means the device met the requirements of these tests.
| Aspect Tested | Study Type | Criteria (Implicit) | Performance (Reported) |
|---|---|---|---|
| Strength & Integrity | Bend and Delamination Testing | Device maintains structural integrity and functionality after bending and resists delamination. | Confirmed the strength, integrity, and functionality of the device. (Specific quantitative results not provided, but implies pass) |
| Sterilization | Sterilization Validation (EO Gas) | Device is sterile and maintains sterility over shelf-life. Meets ISO 11135[2014] standards. | Validation conducted to support EO sterilization. (Implies pass) |
| Packaging Shelf-life | Packaging Validation | Packaging maintains sterility and integrity for the specified shelf-life. Meets ISO, ASTM standards. | Validation conducted to support packaging shelf-life of 5 years. (Implies pass) |
| Biocompatibility | Cytotoxicity Testing (ISO 10993-5) | No unacceptable cytotoxic effects. | Cytotoxicity testing conducted. (Implies pass) |
| Biocompatibility | Sensitization Testing (ISO 10993-10) | No unacceptable sensitization. | Sensitization testing conducted. (Implies pass) |
| Biocompatibility | Irritation Testing (ISO 10993-10) | No unacceptable irritation. | Irritation testing conducted. (Implies pass) |
| Biocompatibility | Acute Systemic Toxicity Testing (ISO 10993-11) | No unacceptable acute systemic toxicity. | Acute systemic toxicity testing conducted. (Implies pass) |
| Biocompatibility | Material-Mediated Pyrogenicity (USP 29 ) | No pyrogenic response. | Material-mediated pyrogenicity testing conducted. (Implies pass) |
| Biocompatibility | Genotoxicity Testing (AMES, Micronucleus - ISO 10993-3) | Not genotoxic. | Genotoxicity (AMES and micronucleus) testing conducted. (Implies pass) |
| Biocompatibility | Implantation Testing (ISO 10993-6) | Acceptable local effects after implantation. | Implantation testing conducted. (Implies pass) |
| Ethylene Oxide Residuals | Testing against ISO 10993-7 | Ethylene oxide residues below acceptable limits. | Testing conducted against ISO 10993-7. (Implies pass) |
| Material Properties (PTFE) | Testing against ASTM D4895 - 10 | PTFE material meets standard specifications. | Testing conducted against ASTM D4895 - 10. (Implies pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes material and mechanical tests, and biocompatibility studies. These types of tests do not typically use "test sets" of patient data in the same way an AI algorithm would.
- Sample Size for Test Set: Not applicable in the context of human patient data for algorithm evaluation. For the bench and in-vitro/in-vivo biocompatibility tests, specific sample sizes are not detailed in this summary document, but the fact that the tests were conducted according to ISO/ASTM/USP standards implies appropriate sample sizes were used for those specific test methods.
- Data Provenance: Not applicable. These tests were likely performed in a laboratory setting, not with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The "ground truth" for these types of device performance tests (e.g., sterility, material strength, biocompatibility) is established by adherence to validated international standards and the results of laboratory measurements, not by expert human interpretation of medical images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. This concept belongs to the evaluation of algorithms where human assessment of data needs to be considered. For a physical device like this, performance is measured against established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a clinical study design used to compare the performance of different diagnostic methods (e.g., human readers with and without AI assistance). This 510(k) summary is for a physical medical implant (a membrane) and focuses on demonstrating its safety and substantial equivalence, not its diagnostic accuracy or the improvement of human performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is not an algorithm, so "standalone performance" in that context is not applicable. Its performance is measured by its material properties, biological interactions, and mechanical integrity.
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests is either:
- Physical/Chemical Standards: (e.g., strength measurements in Bend and Delamination testing, density, thickness).
- Biological Standards: (e.g., absence of cytotoxicity, irritation, sensitization, genotoxicity, pyrogenicity as defined by ISO 10993 and USP standards).
- Microbiological Standards: (e.g., sterility per ISO 11135).
Essentially, the ground truth is adherence to internationally recognized and validated scientific and engineering standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm and no training set, this question is not relevant to the Bio-MEM Ti Reinforced Membrane.
§ 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.