Search Results
Found 1 results
510(k) Data Aggregation
(171 days)
Implantswiss Dental Implant System, Implantswiss Dental Abutment System
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.
The Implantswiss Dental Implant and Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. The Implantswiss Dental Implants are provided as bone level or tissue level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The Implantswiss Bone Level Implants have diameters of 3.3mm, 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The 3.3mm and 3.7mm diameter Bone Level Implants are composed of Titanium Ti6Al4V ELI – ASTM F136-13. The 4.3mm, 4.8mm and 5.5mm diameter Bone Level Implants are composed of Titanium Grade 4 – ASTM F67-13. The Implantswiss Tissue Level Implants have diameters of 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 10mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The Tissue Level Implants are composed of Titanium Grade 4 – ASTM F67-13. The Implantswiss Dental Abutment System consists of Couple, Angled, Solid, O-ring, Multi, Octa, Synocta, Healing, Locator and Multi-Unit Abutments.
The provided text is a 510(k) summary for the Implantswiss Dental Implant System and Implantswiss Dental Abutment System. It outlines the regulatory clearance process, device description, indications for use, and a comparison to predicate devices, including performance testing.
However, it does not contain information about acceptance criteria or a study that uses a machine learning or AI model. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing (biocompatibility, sterilization, mechanical testing) for dental implants and abutments, which are physical medical devices, not AI-driven software.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of medical device submission.
I will provide the information that is applicable based on the text provided, highlighting where the requested AI/ML specific details are not relevant.
Acceptance Criteria and Study for Implantswiss Dental Implant System & Abutment System
This device clearance (K181266) is for physical dental implants and abutments, not a software or AI/ML device. Therefore, the "acceptance criteria" and "study" refer to non-clinical performance evaluations relevant to the material properties, design, and intended use of these dental devices.
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative "acceptance criteria" in a table format for each test. Instead, it refers to compliance with established international standards and FDA guidance documents. The "reported device performance" is a statement of consistency with these standards.
| Acceptance Criteria (Reference to Standard/Guidance) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1:2009 (Evaluation and testing within risk management process) | Conducted according to ISO 10993-1:2009 and FDA Guidance document "Use of International Standard ISO 10993-1..." for each subject device fixture. |
| Cytotoxicity (in vitro) ISO 10993-5:2009 | Tests conducted: Cytotoxicity, Sensitization, Irritation/Intracutaneous Toxicity, Implantation test, Chemical Analysis (SVOC, VOC). (Explicit "performance" results not detailed, but implied as compliant for clearance.) |
| Sensitization ISO 10993-10:2010 | |
| Irritation/Intracutaneous Toxicity ISO 10993-10:2010 | |
| Implantation test ISO 10993-6:2016 | |
| Chemical Analysis (IS0 10993-12, Method 8270D, 8260C) | |
| Sterilization & Shelf Life: | |
| Gamma Ray Sterilization ISO 11137-1 & ISO 11737-2 | Validated to ensure SAL of 10^-6. |
| LAL testing (USP ) | Conducted in accordance with USP . |
| Steam Gravity Sterilization (ISO 17665-1, ISO 17665-2, ISO 11737-2) for non-sterile abutments | Validated to achieve an SAL of 10^-6. |
| Packaging integrity (ASTM F1886, ASTM F1929-15, BS EN 868-5:2009) | Demonstrated that sterility is maintained over 2-year shelf life period for implants. Tests performed: Visual Inspection, Dye Penetration, Seal Peel Strength Test, Sterility Test. |
| Mechanical Testing: | |
| ISO 14801 Dentistry - Dynamic fatigue test | Results consistent with FDA Class II Special Controls guidance and ISO 14801 for worst-case bone level implant/abutment combinations. |
| Surface analysis (SEM, EDS) | SEM found that the implant surface had a homogeneous structure after the SRA process. |
| Consistency with FDA Class II Special Controls guidance document | Non-clinical performance testing supports substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not explicitly provided in the summary. For mechanical and biocompatibility testing, it is generally conducted on a sample of devices (e.g., a specific number of implants/abutments) to demonstrate compliance with standards. The summary states "worst-case" testing was performed.
- Data Provenance: Not applicable in the context of device performance testing for physical implants. These are lab-based tests of the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in this context refers to standard-compliant test methods and material properties, not expert-curated clinical data for an AI/ML model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is relevant to expert panel consensus for clinical data, not materials and mechanical testing.
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 device is a physical dental implant and abutment system, not an AI-assisted diagnostic or therapeutic tool.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device clearance is established by internationally recognized standards (ISO standards), FDA guidance documents, and validated test methods (e.g., for biocompatibility, mechanical fatigue, sterilization parameters). Material specifications (e.g., ASTM F-67, ASTM F-136) also serve as a form of "ground truth" for material composition.
8. The sample size for the training set
Not applicable. There is no AI/ML training set for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set for this physical device.
Ask a specific question about this device
Page 1 of 1