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510(k) Data Aggregation
(120 days)
Atlantis® suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
Atlantis® suprastructures are intended for attachment to a minimum of two (2) implants. Atlantis® suprastructures are compatible with following implants and abutments: (list of compatible implants and abutments follows in the document)
Atlantis suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The subject Atlantis suprastructures include new compatible interfaces of the currently marketed Atlantis suprastructures made by milling (K163350) or additive manufacturing techniques (K163398) for the following abutments and implants: (list of compatible implants and abutments follows in the document). The design of the subject device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the Atlantis suprastructures are fabricated using additive manufacturing (AM) to produce a customized, patient-specific device. The Atlantis suprastructures subject of this bundled premarket notification are fabricated by milling or by additive manufacturing techniques.
The milled Atlantis suprastructures are composed of commercially pure titanium (CPTi) or cobalt chrome alloy and are available in following design types: Bar, Bridge, Hybrid and 2 in 1. Additional design limitations regarding minimum required segment cross-section, maximum span between implants and maximum cantilever extension, have been introduced for Atlantis suprastructures made by milling.
Atlantis suprastructures made by additive manufacturing are provided as Bridge and Hybrid types with optional mechanical retention (pin or cell retention) on the surface. The manufacturing of the Bridges and Hybrids of the Atlantis suprastructures by an additive manufacturing technique start from a titanium alloy and a cobalt-chrome alloy in powder form.
Milled variants of the subject Atlantis® suprastructures are offered in versions composed of unalloyed titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium for Surgical Implant Applications) and cobalt chromium alloy (CoCr) conforming to ISO 22674 (Dentistry – Metallic materials for fixed and removable restorations and appliances). Variants of the subject Atlantis® suprastructures which are fabricated utilizing additive manufacturing are manufactured using titanium alloy powder or cobalt chromium alloy powder conforming to ISO 22674 (Dentistrv – Metallic materials for fixed and removable restorations and appliances).
Fixation screws for use with the subject Atlantis® suprastructures are composed of titanium alloy confirming to ASTM F136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications).
Screws are available for all compatible implants and abutments to screw the Atlantis suprastructures into the implant or onto the abutment.
Labeling is modified by providing a separate compatibility chart which lists all implants and abutments compatible with the Atlantis suprastructures.
This FDA 510(k) summary for the Dentsply Sirona Atlantis® suprastructures does not describe a clinical study for acceptance criteria. Instead, it argues for substantial equivalence to existing predicate devices based on non-clinical performance data and a comparison of indications for use, design, manufacturing techniques, and materials.
Here's an analysis of the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily relies on the equivalency to previously cleared devices. Therefore, explicit "acceptance criteria" in the sense of predefined thresholds for a new study are not presented. Instead, the performance is demonstrated through comparisons to the predicate devices and by referencing a previous fatigue test.
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical clinical indications to predicate devices (K1633350, K163398) | Met by comparison: The clinical indications for use are identical to the predicate devices, differing only in the expanded list of compatible implants and abutments. (Text on page 9 "The indications for use of the subject and predicate Atlantis suprastructures (K163350, K163398) are identical with respect to the clinical indications.") |
| Compatible Interfaces (New) | Maintain structural integrity and performance when attached to new compatible implants/abutments. | Met by non-clinical testing and comparison: Cross-sectional material analysis of interfaces, geometric measurement data, and statistical compatibility analysis of OEM components support compatibility. Reference to results of fatigue testing (K160207) conducted according to ISO 14801. (Text on page 10 "Cross-sectional material analysis of the subject Atlantis suprastructure interfaces with the compatible implants and abutments, comparison to existing worst case interface geometry and reference to results of fatigue testing (K160207) conducted according to test methods of ISO 14801...") |
| Manufacturing Process (Additive Manufacturing) | Additive manufacturing process must be validated and ensure comparable device characteristics. | Met by reference to previous validation: Reference to process validation testing (K163398) for Atlantis suprastructures made by additive manufacturing. (Text on page 10) |
| Sterilization Parameters | Sterilization process must be validated according to relevant international standards. | Met by reference to previous validation: Reference by equivalence to validation of moist heat sterilization parameters conducted according to ISO 17665-1 and ISO 17665-2. (Text on page 10) |
| Biocompatibility | Device materials must be biocompatible. | Met by reference to previous data: Reference by equivalence to biocompatibility data of predicate devices (K163350, K163398). (Text on page 10) |
| Design Parameters (Milled) | Adherence to established design limitations for segment cross-section, span, and cantilever. | Met by comparison: Additional design limitations for some types of milled Atlantis suprastructures are within the design parameters cleared for the predicate device (K163350). (Text on page 10) |
| Design Parameters (Additive Manufacturing) | Adherence to established design parameters. | Met by comparison: The design parameters cleared for the predicate Atlantis suprastructures made by additive manufacturing (K163398) remain unchanged. (Text on page 10) |
| Materials | Conformity to specified ASTM and ISO standards for unalloyed titanium, titanium alloy, and cobalt-chrome alloy. | Met by specification: Milled variants composed of CPTi (ASTM F67) or CoCr (ISO 22674). Additive manufactured variants use titanium alloy powder or CoCr alloy powder (ISO 22674). Fixation screws are titanium alloy (ASTM F136). (Text on page 7) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "cross-sectional material analysis" and "geometric measurement data and statistical compatibility analysis." However, it does not provide specific sample sizes for these analyses. The data provenance is implied to be internal testing conducted by Dentsply Sirona or its subsidiaries, and it's non-clinical. There is no mention of country of origin for this testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device's clearance is based on non-clinical engineering and material testing, and substantial equivalence to existing devices, not a clinical study requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication by experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a dental implant suprastructure, not an imaging AI device where MRMC studies are typically performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this is a physical medical device. The "algorithm" aspect refers to the CAD design process, but the testing focuses on the resulting physical product's performance and compatibility, not an AI algorithm's diagnostic performance.
7. The Type of Ground Truth Used:
For the evaluation of the new compatible interfaces and materials, the "ground truth" is defined by:
- Engineering specifications and dimensional accuracy.
- Material property standards (ASTM F67, F136, ISO 22674).
- Performance standards, particularly ISO 14801 for fatigue testing.
- Comparison to the established performance of the predicate devices.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a training set for an AI algorithm. The CAD design uses pre-programmed libraries and patient-specific scans, but "training set" in the context of machine learning is not relevant here.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the machine learning sense described for this device. The design process is CAD-based, utilizing established engineering principles and material science.
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