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Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

Compatible Implant Systems:

All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.

Dynamic TiBase abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component 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 and non-engaging designs for single-unit and multi-unit restorations, respectively.

For each of the compatible OEM implant lines, the prefabricated titanium base components are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 4 mm, and a platform diameter ranging from 4.30 mm to 5.50 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. All Dynamic TiBase prefabricated titanium base components have a post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The post height of the prefabricated titanium base component ranges from 3.8 mm to 5.40 mm, and from 2.3 mm to 3.8 mm (cut-out height). The cementable post height of the final patient-matched abutment design, measured above the total combined gingival collar, shall be no less than 4 mm.

All zirconia superstructures (copings) used to complete the final two-piece subject device Dynamic TiBase abutment will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table:

(1) for the compatible sizes shown in Table 1
(2) minimum gingival height in the titanium base, not the zirconia superstructure

The required cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is Nova Resin Cement cleared in K213609.

Also, the subject of this submission are seven (7) abutment screws for use with the subject abutments.

This FDA 510(k) clearance letter pertains to a dental implant abutment — the Dynamic TiBase — not an AI-powered diagnostic device or software. Therefore, the information typically requested about acceptance criteria and study designs for validating AI/ML-based medical devices (such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

The "performance data" section in this 510(k) summary refers to traditional engineering and biocompatibility testing for a physical medical device, not performance metrics for an algorithm.

Here's how to interpret the provided document in the context of "acceptance criteria" and "proof":

Acceptance Criteria and Reported Device Performance (as inferred for a physical device):

For a physical device like the Dynamic TiBase, the "acceptance criteria" are generally met through demonstrating substantial equivalence to a previously cleared predicate device. This involves validating material properties, manufacturing processes, functional performance (e.g., mechanical strength, compatibility), and biocompatibility.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate substantial equivalence.

Regarding the specific questions about an AI/ML context:

1. A table of acceptance criteria and the reported device performance: Provided above, adapted for a physical medical device.
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this physical device refers to the number of physical abutment samples or material samples subjected to mechanical, biocompatibility, and MRI testing. The document does not specify exact sample numbers for these engineering tests, only the standards used (e.g., ISO 14801 typically specifies minimum sample sizes). Data provenance is "non-clinical data" generated from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a dental abutment's performance is established by engineering standards, material specifications, and physical testing, not by expert human interpretation of images or clinical outcomes in the same way as an AI diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a concept used in evaluating human reader performance in AI studies.
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 for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI algorithm's performance.
7. The type of ground truth used: For a physical device, "ground truth" is defined by adherence to established engineering standards (e.g., ISO 14801 for mechanical strength), material properties, and biocompatibility standards. "Reverse engineering dimensional analysis" served as a form of "ground truth" for compatibility. No pathology or outcomes data was used for this premarket notification.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) clearance is for a physical medical device (dental abutment), and the "performance data" section details the engineering and material testing conducted to demonstrate its safety and effectiveness, primarily through substantial equivalence to previously cleared devices. It does not involve AI/ML validation methodologies.

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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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Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

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. Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively. For each of the compatible OEM implant lines, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 5 mm, and a prosthetic platform diameter ranging from 4.3 mm to 5.9 mm. Additional gingival height and angulation may be provided in the zirconia superstructure. 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. The prosthetic post heights range from 3.8 mm to 4.5 mm (maximum height), and from 2.3 mm to 2.7 mm (cut-out height). 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. All subject device abutments and abutment screws are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 and ISO 5832-3. All zirconia copings (superstructures) for use with the subject device Dynamic TiBase will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The provided text is a 510(k) Summary for a medical device (Dynamic TiBase dental abutments). It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, it does not contain any information about acceptance criteria, the study design, or performance metrics typically associated with AI/ML-based medical devices.

The document explicitly states: "No clinical data were included in this submission." and focuses on non-clinical data to demonstrate substantial equivalence, primarily through:

• Mechanical testing: "mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments in conjunction with the compatible OEM implants."
• Reverse engineering analysis: "reverse engineering analysis (of OEM implants, OEM abutments, and OEM abutment screws) demonstrating compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement."
• Material compatibility and sterilization: referencing previous 510(k) submissions for biocompatibility and sterilization validation.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance in the context of an AI/ML-based device (e.g., sample size, ground truth, expert adjudication, MRMC studies), as this information is not present in the provided text. The device described is a physical dental abutment, not an AI/ML diagnostic or assistive tool.

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Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

The purpose of this submission is to obtain marketing clearance for Dynamic TiBase, two-piece titanium base abutments that require the fabrication of patient-specific custom zirconia superstructures using CAD-CAM technology. In final, finished form, the subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-half (titanium base) with a bonded CAD-CAM zirconia top-half. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.

The provided text is a 510(k) summary for a medical device called "Dynamic TiBase." This summary focuses on demonstrating the substantial equivalence of the device to existing predicate devices, rather than an independent study presenting acceptance criteria and performance data in the typical AI/device sense. Therefore, many of the typical questions for AI performance studies are not applicable.

However, I can extract the relevant information from a regulatory perspective concerning the acceptance criteria and the "study" (which in this context refers to non-clinical testing and comparison to predicates) that proves the device meets regulatory requirements for clearance.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are not numerical performance metrics like sensitivity/specificity for AI, but rather regulatory compliance and performance thresholds for mechanical and material properties compared to recognized standards or predicate devices. The "reported device performance" refers to the demonstration that the device meets these standards through testing or comparison.

1 K212108 submission included confirmatory biocompatibility testing for finished subject devices made from titanium alloy with cemented zirconia superstructures performed according to ISO 19003-5 and ISO 10993-12.

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

• Sample Size: Not specified in terms of distinct "samples" for an AI test set. The performance data consists of non-clinical bench testing (static compression and compression fatigue testing) of "worst-case constructs" of the device. The number of constructs tested for ISO 14801 is not explicitly stated but generally involves a statistically significant number of samples to establish fatigue limits. For the MRI safety, it was an analysis based on scientific rationale and published literature, not a test set of physical devices.
• Data Provenance: The document does not specify a country of origin for the test data directly, but the manufacturer is Talladium España, SL (Spain), and the testing was performed to international ISO standards and FDA guidance. The data is retrospective in the sense that it relies on established standards and principles, and some data is referenced from previous clearances (K212108). It is an assessment of the device's physical properties.

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

• Not Applicable (N/A): This is a non-clinical device clearance based on material science, mechanical testing, and regulatory comparison. There is no "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" for compliance is essentially the adherence to international standards (ISO) and FDA guidance, which are established by expert committees in their respective fields (e.g., materials science, biomechanics, sterilization).

4. Adjudication Method for the Test Set

• Not Applicable (N/A): As there is no "ground truth" established by human experts in a diagnostic or clinical sense, there is no adjudication method. The compliance is assessed against predefined standards and testing protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: This is not an AI device or a diagnostic device where human reader performance is relevant. It's a dental implant component undergoing physical and material performance evaluation.

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

• Not Applicable (N/A): This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Referenced Standards and Accepted Testing Methodologies: The "ground truth" for this device's safety and effectiveness is its compliance with established international standards (ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665 and ISO 11737 for sterilization, ASTM F136, ISO 5832-3, ISO 13356 for materials), and FDA guidance for MRI safety. It also relies on the concept of "substantial equivalence" to legally marketed predicate devices, meaning its performance and characteristics are comparable to devices already deemed safe and effective.

8. The Sample Size for the Training Set

• Not Applicable (N/A): This refers to AI algorithms. For this physical device, there is no "training set" in the AI sense. The design and manufacturing processes are developed through engineering and materials science principles, refined over time, and verified through testing.

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

• Not Applicable (N/A): See point 8.

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Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

The purpose of this submission is to obtain marketing clearance for Dynamic TiBase, a series of twopiece titanium base abutments that require the fabrication of patient-specific custom superstructures using CAD-CAM technology. In final, finished form, the subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-half (titanium base) with a bonded CAD-CAM zirconia top-half. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.

This document is a 510(k) Premarket Notification for the Talladium España, SL Dynamic TiBase, which is an endosseous dental implant abutment. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness or safety in the same way clinical trials do. Therefore, the information provided focuses on non-clinical data and comparisons to existing devices, rather than clinical study results with human subjects.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them, specifically in the context of a 510(k) submission:

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

For a 510(k) submission for a device like this, the "acceptance criteria" are not clinical performance metrics in the traditional sense (e.g., sensitivity, specificity for a diagnostic device). Instead, they revolve around demonstrating substantial equivalence to predicate devices in terms of:

• Intended Use: The device performs the same function for the same patient population.
• Technological Characteristics: The device has similar design, materials, and operating principles.
• Performance (Non-Clinical): The device performs similarly to or better than the predicate in engineering/bench tests relevant to its function and safety. Any differences in technological characteristics must not raise new questions of safety or effectiveness.

The reported device performance is primarily based on non-clinical (bench) testing and comparison tables, not clinical studies in human subjects.

Here's a table summarizing the "acceptance criteria" (or areas of equivalence demonstration) and the reported device performance as per the document:

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document explicitly states "No clinical data were included in this submission." The "studies" were non-clinical (bench) tests. While the ISO 14801 standard specifies the number of samples for fatigue and static testing (typically 5-10 for static, 10-12 for fatigue), the exact sample sizes used for each specific test (e.g., number of abutments tested at different loads) are not detailed in this summary. It only says "worst-case constructs" were tested.
• Data Provenance: The data is non-clinical (bench testing) performed by the manufacturer or a contracted lab. The manufacturer is Talladium España, SL, located in Lleida, Spain. This indicates the testing was likely done in Spain or a European lab adhering to ISO standards. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a 510(k) submission based on non-clinical data, there are no "experts" establishing a clinical "ground truth" through consensus on patient cases. The "ground truth" for non-clinical testing is compliance with established engineering and biocompatibility standards (e.g., ISO 14801, ISO 10993). The "experts" here would be the engineers and scientists who designed and conducted the tests and analyzed the results according to these international standards. Their qualifications are inherent in their ability to perform such testing and demonstrate compliance with these standards.

4. Adjudication method for the test set

Not applicable. There's no clinical test set requiring adjudication. The non-clinical tests (biocompatibility, sterilization, mechanical) are evaluated against predefined acceptance criteria established by the relevant 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 device is a dental implant abutment, not an AI-powered diagnostic imaging tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this type of device.

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

The "ground truth" for this 510(k) submission is compliance with established international engineering standards (e.g., ISO 14801 for mechanical performance, ISO 10993 for biocompatibility, ISO 17665-1 and ISO 11737-2 for sterilization) and the demonstration of substantial equivalence to predicate devices. This is achieved through:

• Bench Test Results: Quantitative data from static compression and compression fatigue tests.
• Material Specifications: Conformance to ASTM and ISO material standards.
• Biocompatibility Test Reports: Results showing no adverse biological reactions.
• Sterilization Validation Data: Proof of effective sterilization.
• Direct Comparison: Tables and textual analysis comparing the subject device's features and performance to those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for a physical device.

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3.0 Dynamic TiBase are intended for use with dental implants as a support for multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Not Found

I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain information about acceptance criteria or the study that proves a device meets those criteria, specifically concerning an AI/ML medical device.

The document is a clearance letter for a dental device called "3.0 Dynamic TiBase," which is a physical endosseous dental implant abutment. The content discusses:

• The FDA's review and determination of substantial equivalence to legally marketed predicate devices.
• Regulatory classifications, general controls, and additional controls (if applicable).
• Requirements for registration, listing, labeling, medical device reporting, and good manufacturing practices.
• Contact information for the FDA's Division of Industry and Consumer Education.
• The "Indications for Use" for the 3.0 Dynamic TiBase, including compatibility with specific implant systems (DIO® and OSSTEM®), dimensions, retention type, screw type, angulation, and abutment connection.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance, especially for an AI/ML device, as this document is not related to such a product or study.

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