(145 days)
The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
TS Abutment System is made of titanium alloy. TS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. TS Abutment System is similar to other commercially available products based on the intended use, technology used, material composition employed and performance characteristics.
The provided document is a 510(k) summary for the Osstem Implant Co., Ltd. TS Abutment System. It describes the device and claims substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, nor does it involve expert reviews or clinical trials for such metrics.
Instead, the submission focuses on demonstrating substantial equivalence through comparisons of technical characteristics and performance testing (bench testing, biocompatibility, sterilization validation, etc.) against existing predicate devices and established standards.
Therefore, most of the requested information regarding acceptance criteria for device performance (accuracy, sensitivity), sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment would not be applicable to this type of regulatory submission. This submission does not pertain to an AI/ML powered device, but rather a physical dental implant component.
However, I can extract information related to the technical comparisons that demonstrate substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in terms of numerical performance metrics (e.g., specific thresholds for accuracy, sensitivity). Instead, the acceptance is based on demonstrating that the subject device's characteristics and performance are "substantially equivalent" to predicate devices, often by adhering to established standards or by justifying that any differences do not raise new questions of safety or effectiveness. The reported "performance" for most components is implicitly that they function equivalently to their predicates and meet relevant mechanical and biological standards.
Here's a summary of the non-clinical performance and "acceptance criteria" through comparative analysis:
| Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Properties (Fatigue) | The fatigue performance of the proposed device is considered to be equal to or greater than that of the reference/primary predicate device. This is often justified by: |
- Same design, function, connection, and platform as predicate.
- Adherence to ISO 14801 standard (maintaining 11mm distance between embedding plane and hemispherical loading member).
- Differences (e.g., added lengths or diameters) not creating a new worst-case scenario. | Rigid Abutment: No additional fatigue testing conducted, as the proposed device has the same design, function, connection, platform, and moment arm as the reference/predicate, and added lengths are within acceptable ranges or previously cleared for similar components.
Transfer Abutment: No additional fatigue testing conducted for similar reasons, justifying that changes in connection features were evaluated and not a new worst case, and that the device has the same moment arm.
Angled Abutment: No additional fatigue testing conducted, as differences in feature (guide for connecting with implant body) do not change the fundamental design or platform and the proposed device's fatigue is considered equal to or greater than the predicate.
FreeForm ST Abutment: No additional fatigue testing conducted, as added dimensions are within the range of the reference device and it maintains the same moment arm.
Temporary Abutment: No additional performance test needed as it's for temporary use, and the proposed gingiva height has primary predicate clearance.
Multi Abutment: No additional fatigue testing conducted, as added dimensions (gingival height) are covered by primary predicates and it maintains the same moment arm.
Ti Cylinder Screw: No fatigue testing considered necessary as it's a component using with cylinder, and material biocompatibility is established.
Convertible Abutment: No additional performance tests as difference is sterilization process. Its mechanical performance is expected to be equivalent to predicate. |
| Biocompatibility | The device materials must have acceptable biocompatibility, typically demonstrated by using materials already cleared in predicate devices or by following ISO 10993-1. | The TS Abutment System uses the same materials (e.g., Ti-6Al-4V (ASTM F136), Titanium Gr.3 (ASTM F67), Titanium Gr.4 (ASTM F67)), manufacturer, manufacturing process, and surface treatment as primary predicate and reference devices. Therefore, no additional biocompatibility testing was conducted. |
| Sterilization Validation | The sterilization process must be validated to ensure sterility, or justified if changes from predicates do not create a new worst-case scenario. For sterile devices, shelf-life must be validated. | For those components provided sterile, the validation of the gamma irradiation process was previously conducted for the predicate device. Changes in dimensions for the subject device do not create a new worst-case scenario for sterilization, thus no additional validation was required. Shelf-life for sterile components (e.g., Transfer Abutment, Angled Abutment, Multi Abutment, Convertible Abutment, Port Abutment, Stud Abutment, Healing Abutment) is established as 8 years. For non-sterile devices made of titanium, no specific shelf-life is considered for the material itself due to its known stability. |
| Pyrogen Test | Absence of pyrogens to meet established standards (e.g., ISO 10993-11:2006 and USP). | Bacterial Endotoxin Test Report on implants was referenced from K161604, indicating previous compliance. |
| MR Compatibility | Evaluation of magnetically induced displacement force and torque based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods et al., 2019), addressing parameters for magnetically induced displacement force and torque for all compatible implant bodies, abutments, and fixation screws and material composition. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission relies on comparisons to predicate devices and existing standards, not a new test set for performance evaluation in the clinical sense (e.g., diagnostic accuracy).
- Data Provenance: The document references previously cleared 510(k) submissions (e.g., K182091, K161689, K221684, K163634, K161604, K120847) from Osstem Implant Co., Ltd. and one from Southern Implants (Pty) Ltd. The specific country of origin for the data from these predicate clearances is not detailed in this summary, but the manufacturer of the subject device is based in the Republic of Korea. The data is retrospective, as it refers to performance data and justifications from prior clearances.
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. No "ground truth" as typically understood in AI/ML diagnostic performance studies was established or used for this device's submission. The evaluation is based on engineering principles, materials science, and conformity to recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set was used.
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 not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" of this nature was used. The ground truth, in a regulatory sense for this type of device, is conformity to established material specifications, manufacturing processes, and recognized performance standards (like ISO 14801 for fatigue testing).
8. The sample size for the training set
Not applicable. This is not an AI-powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)