Search Results

MTA Fillapex is a root canal sealer intended for the permanent sealing of root canals and may be used in combination with root canal obturation materials.

MTA Fillapex is a mineral trioxide aggregate (MTA) and resin root canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA Fillapex is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation. The device is provided non-sterile.

This document describes the Angelus Indústria de Produtos Odontológicos S/A MTA Fillapex, a root canal sealer. The submission is a 510(k) premarket notification (K113568) and focuses on demonstrating substantial equivalence to previously marketed devices.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document states that "Performance testing that conformed to the protocols and recommended values described in ISO 6876 Dental root canal sealing materials was performed." However, it does not explicitly list the specific acceptance values (e.g., "flow > X mm") for each parameter from ISO 6876, nor does it provide the exact numerical results for MTA Fillapex for each test. It simply states that "Test reports included [list of tests]."

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

This submission is a 510(k) for a medical device and relies on non-clinical performance testing and biocompatibility data, not a clinical study with a "test set" of patient data.

• Sample Size for Non-Clinical Testing: The document does not specify the exact number of samples (e.g., number of specimens for flow testing) used for each non-clinical test. It broadly states that "side-by-side cytotoxicity testing" and "performance testing" were performed.
• Data Provenance: The testing was performed by or for the manufacturer, Angelus Indústria de Produtos Odontológicos S/A, based in Brazil. The data is thus considered internal manufacturer data from controlled laboratory settings. It is not retrospective or prospective patient data from a clinical setting.

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

Not applicable. This submission does not involve human expert interpretation of clinical data or images to establish a "ground truth." The "ground truth" for non-clinical performance tests is determined by the standardized methods and measurements defined in ISO 6876.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical data requiring expert adjudication. The non-clinical tests follow direct measurement and evaluation against pre-defined ISO standards.

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

Not applicable. This is a traditional medical device (root canal sealer), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC study, AI assistance, or effect size related to human reader improvement is relevant or discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical performance tests (flow, working time, setting time, etc.), the "ground truth" is defined by the protocols and recommended values described in the international standard ISO 6876 Dental root canal sealing materials. For biocompatibility, the ground truth is established by the methods outlined in ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical medical devices of this type. Performance is demonstrated through direct testing against established material science standards.

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

Not applicable, as there is no "training set."

Ask a specific question about this device

The Thommen SPI® ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.

The two-stage HA-Ti Dental Implant acquired from HATI Dental AG by Thommen Medical AG has been modified to make it a one-piece one-stage transgingival implant and will be marketed as the SP1® ONETIME Dental Implant. Other components of the HA-Ti Dental Implant System have not been modified and are suitable for use with the modified implant, and will be sold under the SP10 Dental Implant System name.

The Thommen SP1® ONETIME Dental Implant is a one-stage root form endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transqingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in three lengths (8 mm, 11 mm, 14 mm, not including the 2.9 mm transgingiyal portion), with two diameters (4.2 mm, 5.0 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance,

The provided 510(k) summary for the Thommen SPI® ONETIME Dental Implant does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for a diagnostic AI device.

This document is a premarket notification for a Class III medical device (an endosseous dental implant), and the regulatory review process for such devices focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies designed with AI in mind.

Here's why the requested information cannot be fully provided based on the input:

• Dental Implants vs. AI/Diagnostic Devices: The document concerns a physical implant, not a software algorithm or an AI-powered diagnostic tool. The "acceptance criteria" and "device performance" in this context refer to material properties, sterilization methods, and intended use as defined by the FDA's substantial equivalence pathway, not metrics like sensitivity, specificity, or AUC as seen in AI studies.
• Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the SPI® ONETIME Dental Implant is substantially equivalent to a legally marketed predicate device (Thommen Medical AG HA-Ti Dental Implant). This means showing it has the same intended use, operating principle, basic design, materials, packaging, and sterilization processes. Performance is inferred through the predicate device's established safety and effectiveness, and through material conformity to standards like ASTM F67 and ISO 5832-2.
• Lack of AI-Specific Information: All the points you've requested (sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training/test sets) are specific to the evaluation of AI/ML-based medical devices or diagnostic tools. These concepts are not applicable to the 510(k) submission for a physical dental implant.

Therefore, I cannot populate the table or answer the questions as they pertain to AI device evaluation. The document describes a traditional medical device submission.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device