(72 days)
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.
| Acceptance Criteria Category | Specific Criterion / Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Fatigue strength according to ISO 14801 | Mechanical performance testing of the subject device was performed in conformance to ISO 14801. The fatigue limit data demonstrated that constructs of the subject device abutments fabricated to the limits stated in the proposed labeling, in combination with previously-cleared compatible Biotech Dental, SAS Kontact™ Dental Implant System implants, have sufficient strength for their intended use. Specific effect size is not quantified, but sufficiency for intended use is claimed. |
| Biocompatibility | Conformance to ISO 10993-12 and ISO 19003-51 | Biocompatibility testing according to ISO 10993-12 (referenced from K212108) was performed. 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 (provided as part of K212108 submission). |
| Sterilization Validation | Conformance to ISO 17665-1 and ISO 11737-2 | Moist heat sterilization validation according to ISO 17665-1 and ISO 11737-2 (referenced from K212108). The device is provided non-sterile and sterilized by the end user via moist heat. |
| MRI Safety | FDA guidance, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (May 2021) | Non-clinical analysis was performed using scientific rationale and published literature (TO Woods et al. 2021) to evaluate the device in the MR environment. The analysis addressed parameters per the FDA guidance, including magnetically induced displacement force and torque. |
| Material Specifications | ASTM F136 (for Ti-6Al-4V), ISO 5832-3 (for Ti-6Al-4V), ISO 13356 (for Zirconia) | All abutments and abutment screws are made of Ti-6Al-4V conforming to ASTM F136 and ISO 5832-3. Zirconia copings conform to ISO 13356. These are identical materials to the predicate device. |
| Design Parameters (Zirconia Superstructure) | Specific limits for min wall thickness, min post height, max and min gingival height, max angulation. | Parameters are defined: Minimum wall thickness - 0.55 mm; Minimum post height for single-unit restorations - 4.0 mm; Maximum gingival height - 5.37 mm (in the zirconia superstructure); Minimum gingival height - 1.0 mm (in the TiBase); Maximum angulation - 30°. Mechanical testing (ISO 14801) mitigates minor differences in these parameters compared to the predicate. |
| Intended Use / Indications | Substantially equivalent to predicate device K212108 | The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate device K212108, with minor differences in compatible implants and milling centers. |
| Device Configuration | Similar to predicate (two-piece abutment, titanium base + CAD-CAM zirconia top-half) | The final finished device is 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, which is consistent with the predicate. |
| Implant Compatibility | Compatible with Kontact™ Dental Implant System | Established compatibility with Kontact™ Dental Implant System implants (3.6 mm, 4.2 mm, 4.8 mm, 5.4 mm body/platform diameters) through a business agreement and identical interface connections/platforms as cleared in reference device K210220. |
| Manufacturing Process | Identical to predicate for titanium components | Subject device titanium alloy components are manufactured from identical materials, in the identical facilities using identical manufacturing processes as used for Talladium España, SL products cleared previously in K212108. Anodization process for abutment screws is also identical to previously cleared products. |
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.
§ 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.)