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Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
TRI Screws are intended to secure TRI-matrix® Crown Abutments to TRI-matrix® implants.

Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging designs for single-unit restorations.
Dynamic TiBase abutments are provided in sizes compatible with the following SGS® Dental Implants System implants:
SGS P1D, Conical connection, 5.0 mm body diameter, 3.5 (3.0 mm) platform; and
SGS P7N, Narrow Conical connection, 3.2 mm body diameter, 2.1 (2.5 mm) platform.
All Dynamic TiBase abutments are provided in a straight design (no angulation in the TiBase portion). All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary.
For the compatible SGS P1D Concal connection implant, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) of 0.5 mm, or 3.0 mm, and a prosthetic platform diameter of 4.3 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. For the compatible SGS P1D Conical connection implant, the abutments have a prosthetic post height (length above the gingival height) of 4.0 mm, and a cut-out height of 2.5 mm.
For the SGS P7N Narrow Conical connection implant, the gingival height (in the titanium base) is 0.5 mm or 1.5 mm. and a prosthetic platform diameter of 3.8 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. For the compatible P7N Narrow Conical connection implant the abutments have a prosthetic post height (length above the gingival height) of 4.5 mm, and a cut-out height of 2.5 mm. Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration.
The subject device TRI Screws are to be used only to attach TRI-matrix® Crown Abutments. The TRI-matrix® Crown Abutments and TRI-matrix® implants are manufactured by TRI Dental Implants Int. AG and were cleared in K203660. The TRI screws have a hexalobular instrument interface, a screw head diameter of 2.6 mm, 1-72 UNF thread, and an overall length of 5.15 mm or 7.6 mm. The TRI Screws are anodized to a gold color and are only intended to be used with straight abutments. The compatible abutments are made from zirconia and are for direct final restorations.

This is a substantially equivalent (SE) determination letter from the FDA, not a study report. It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics. Therefore, it does not contain the detailed information about acceptance criteria and study results you requested for a novel device.

The document states that a non-clinical mechanical testing study was performed to support the performance of the abutments and zirconia superstructure. However, the specific acceptance criteria and detailed results of this study are not provided in this regulatory document.

Here's a breakdown of what can be extracted or inferred based on your request, and what is explicitly not available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion for this FDA clearance is "substantial equivalence" to predicate devices. This means the device has the same intended use and similar technological characteristics (materials, design, manufacturing, sterile processing, etc.), and any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that mechanical testing conducted according to ISO 14801 was performed to support the performance of the subject device abutments in conjunction with compatible OEM implants. It also mentions a "non-clinical worst-case MRI review" using scientific rationale and published literature. However, the specific numerical acceptance criteria for these tests (e.g., specific fatigue limits, displacement values) and the actual quantitative results are not provided in this summary. It only states that these tests were performed to mitigate risks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided in the document. The mechanical testing would have involved a specific number of samples (e.g., implant-abutment assemblies) tested according to ISO 14801. The document only states that such testing was performed to demonstrate performance. The country of origin for the testing data is not mentioned, but the manufacturer is Talladium España, SL (Spain).

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)

• This kind of information is not applicable to this type of regulatory submission (Class II dental implant components). There is no "ground truth" established by experts in the context of diagnostic accuracy for this device. The assessment is based on engineering principles, materials science, and mechanical testing against recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This is not applicable as it pertains to expert consensus in diagnostic studies, not mechanical testing of medical devices.

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 is not applicable. This is a physical dental implant component, not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable. This is a physical dental implant component, not an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the mechanical testing, the "ground truth" would be the physical properties and mechanical integrity of the device measured against predetermined performance specifications outlined in relevant ISO standards (e.g., ISO 14801 for fatigue testing of dental implants). For biocompatibility, it's testing against ISO 10993 standards.

8. The sample size for the training set

• This is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

• This is not applicable.

Summary of available and missing information regarding acceptance criteria and study:

This document is a regulatory communication affirming substantial equivalence based on non-clinical data, not a detailed scientific study report. For the specific acceptance criteria and quantitative performance results, one would typically need to refer to the full 510(k) submission, which is not publicly available in this level of detail.

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