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TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function.

TRINON Titanium QZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral and central incisors.

TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients.

QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.

TRINON Titanium QZA Dental Implants are made of titanium grade 5. These are two-stage implants. They have a hexagonal internal cone connection and a spiralock internal thread design. Furthermore, QZA Dental Implants have micro threads in cortical part.

TRINON Titanium QZA Dental Abutments are also called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct QZA Dental Implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedures in the IFU.

The RS Implants are made of titanium Grade 5. The RS Dental Implants are two-stage implants and are available in 4 diameters for ideal implant selection and four easily identifiable platforms for efficient prosthetic restoration (color-coding). All diameters are available in lengths of 8.5 mm, 10 mm, 11.5 mm, 14.5 mm and 16 mm.

The RS Dental Implants have a conical hexagonal interlock. The RS Dental Implants are selftapping high torque arrow-shaped implants with counterclockwise self-tapping function. RS Dental implants have micro threads in cortical part of the implant feature.

The RS Abutments are made of titanium Grade 5. These are usually called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct RS dental implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedure descripted in the IFU.

The provided text describes a 510(k) premarket notification for the TRINON Titanium QZA and RS Dental Implant Systems. This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, rather than proving its effectiveness through clinical trials with specific performance metrics.

Therefore, the acceptance criteria and study information, as commonly sought for AI/ML device performance, are not explicitly present in the provided text. The document focuses on demonstrating substantial equivalence through comparisons with predicate devices and performance bench testing rather than clinical study outcomes.

However, I can extract information related to the performance data presented (bench tests and biocompatibility).

Here's an interpretation based on the provided text, addressing the points where information is available or noting its absence:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates) for a study proving effectiveness. Instead, it relies on demonstrating substantial equivalence to predicate devices and acceptable results from specific bench tests and biocompatibility studies.

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

• Sample Size for Testing: The document does not specify a "test set" in the context of clinical data. For the reported bench tests (biocompatibility, mechanical, sterilization, packaging), the sample sizes are not explicitly stated. The tests refer to "test material," "worst case product," or "worst case QZA and RS Dental Implant System with the worst case Abutments," implying a limited number of samples selected specifically for these engineering tests.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based. The device manufacturer, TRINON Titanium GmbH, is based in Karlsruhe, Germany.

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 information is not applicable as the document does not describe a clinical study involving human expert review for establishing ground truth or diagnostic performance. The context is product design validation against standards and comparison to predicate devices, not AI/ML diagnostic interpretation.

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

• This information is not applicable as there is no clinical test set or subjective expert evaluation for adjudication.

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

• No MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or described. This document pertains to a dental implant system, not a diagnostic AI/ML device.

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

• Not applicable. This is a medical device (dental implant and abutment) and not an algorithm-only device.

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

• Ground truth, in the context of this 510(k) submission, is established through adherence to recognized international and national standards (e.g., ISO 10993 for biocompatibility, ISO 14801 for mechanical fatigue, ISO 11137 for sterilization) and comparison of technological characteristics to existing FDA-cleared predicate devices. There is no clinical "ground truth" (like pathology or outcomes data) presented.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not applicable. There is no training set.

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