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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.

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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The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

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 and are indicated for compatibility with the following implant and abutment systems: (list of compatible implants and abutments follows in the document)

The subject of this bundled 510(k) consists of the proposed Multibase Abutments EV with accompanying accessories and the corresponding ATLANTIS™ Suprastructures, which are currently marketed under premarket notification K160207 and are proposed for modification under this submission to include compatibility with the proposed Multibase Abutments EV. The proposed devices are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible.

The subject Multibase Abutments EV are additional components for the existing OsseoSpeed™ EV implants (cleared in K120414 under the name OsseoSpeed™ Plus) and the OsseoSpeed™ Profile EV implants (K130999). The subject Multibase Abutments EV are designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. They are provided in three platform diameters (3.6. 4.2 and 4.8 mm) and available as straight version and in two angles (17° and 30°). The straight abutments are one-piece abutments and provided in three gingival heights (1.5, 2.5 and 3.5 mm). They have a nonindexed interface. All abutments with a 17° or 30° angle represent two-piece abutments and are available in two gingival heights (1.5 and 2.5 mm) with an indexed or non-indexed interface. The two-piece, angled variants of the Multibase Abutment EV devices consist of the abutment body and a screw channel cap which is threaded to the abutment body to cover the abutment body's connection screw channel. The screw channel cap features internal threads to facilitate connection of screw-retained restorations. The subject Multibase Abutment EV devices are also designed for compatibility with the temporary prosthetic cylinder and bridge screw components of the reference predicate NobelActive Multi-Unit Abutment system (K072570).

The ATLANTIS™M Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the proposed 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 ATLANTISTM Suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. The proposed abutment-interface of the ATLANTIS™ Suprastructures, compatible with the proposed Multibase Abutments EV. are available in the same design types as cleared for the predicate ATLANTISTM ISUS Implant Suprastructures in K160207:

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
2. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
3. Hybrid Intended as a fixed denture framework.
4. 2 in 1 Intended as a fixed supporting structure for a removable dental prosthesis in combination with a hybrid denture framework retained by friction fit. The primary structure is a non-standard bar configuration. The secondary structure is a bridge or hybrid denture restoration with a tapered friction fit connection rather than a screwretained connection.

Screws are available for all compatible implant and abutments systems to attach the ATLANTISTM Suprastructures to the implant or onto the abutment.

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided text describes a 510(k) premarket notification for dental implant components (Multibase Abutments EV and ATLANTISTM Suprastructures). This type of submission relies on demonstrating substantial equivalence to existing legally marketed devices (predicates), rather than proving safety and effectiveness de novo through a clinical trial with specific performance criteria for a novel device.

Therefore, the concept of "acceptance criteria" for a new, standalone device's performance in a clinical study, and a "study that proves the device meets the acceptance criteria" in that context, is not directly applicable to this document.

Instead, the "acceptance criteria" here are essentially the demonstration that the new device shares fundamental technological characteristics and indications for use with the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" is the collection of non-clinical data (e.g., sterilization validation, fatigue testing, geometric analysis) showing substantial equivalence.

Given this, I will reframe the requested information to align with the provided document's nature as a 510(k) submission for dental implant abutments and suprastructures.

Dental Implant Abutments and Suprastructures (K163350)

1. Table of Acceptance Criteria (Substantial Equivalence) and the Reported Device Performance

ATLANTIS™ Suprastructures: Indications for use are identical to the predicate ATLANTISTM ISUS Implant Suprastructures (K160207), with the addition of compatibility with the Multibase Abutment EV device. They are indicated for attachment to dental implants or abutments in partially or totally edentulous jaws for restoring chewing function, intended for attachment to a minimum of two implants, and compatible with a listed range of implant and abutment systems. |
| Similar Fundamental Technology | Multibase Abutments EV: Classified as endosseous dental implant abutments, intended for prosthetic restoration. Design features (screw-retained, multi-unit restoration, internal interface) and material (Ti-6Al-4V) are consistent with predicate devices (OsseoSpeed™ Angled Abutment EV and NobelActive Multi Unit Abutment). Differences in abutment design (one-piece/two-piece) and angulation/gingival height ranges addressed by testing.

ATLANTIS™ Suprastructures: Classified as endosseous dental implant abutments, intended for prosthetic restoration. Design types (Bar, Bridge, Hybrid, 2 in 1), prosthesis attachment (screw-retained, friction-fit), platform diameter, interface (internal, external), and materials (CPTi, CoCr for suprastructure; Ti-6Al-4V ELI for screw) are consistent with the predicate ATLANTISTM ISUS Implant Suprastructures. |
| Biocompatibility | The materials used for both devices and their accompanying screws, as well as the manufacturing process, are unchanged compared to their respective primary predicate devices (OsseoSpeed™ Angled Abutment EV (K121810) and ATLANTIS™ ISUS Implant Suprastructures (K160207)). No additional biocompatibility testing was performed, relying on the predicates' established biocompatibility. |
| Performance (Non-Clinical) | Sterilization: Validated for sterile, straight Multibase Abutments EV variants by equivalence to existing validations conforming to ISO 11137-1/2 (SAL of 10^-6). Angled variants were specifically validated to ISO 11137-1/2 (SAL of 10^-6). Moist heat sterilization for non-sterile components validated by equivalence to ISO 17665-1/2 (SAL of 10^-9).

Packaging and Shelf Life: Validated per ISO 11607 and ASTM F1980 (referenced, no details provided).

Fatigue Testing: Dynamic fatigue testing performed on the worst-case construct (angled, two-piece assembly) of Multibase Abutments EV devices according to ISO 14801. Results support substantial equivalence.

Geometric Compatibility: Geometric measurement data and statistical compatibility analysis for Multibase Abutments EV with temporary prosthetic cylinder and bridge screw components of predicate (K072570) support compatibility.

Cross-sectional Material Analysis: For ATLANTIS™ Suprastructures' interface with Multibase Abutments EV; compared to existing worst-case interface geometry. Analysis showed the new interface does not present a new worst case, supporting substantial equivalence. |
| Safety and Effectiveness | Based on the above, the differences in technological characteristics do not raise new questions of safety or effectiveness. |

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

• Test Set Sample Size: Not applicable in the context of a clinical trial. The "test set" here comprises the various physical configurations and conditions tested in the non-clinical studies.
  • For fatigue testing (ISO 14801), multiple samples of the "worst case construct" (angled Multibase Abutments EV) would have been used. The exact number is not specified, but typically this standard requires a minimum of 5-10 samples per test group.
  • For sterilization validation, the sample sizes would depend on the specific validation protocol (e.g., bioburden testing, dose mapping) but are not explicitly stated.
  • For geometric measurements, the "sample size" would refer to the number of individual components measured to ensure dimensional compliance and compatibility, but this is not specified.
• Data Provenance: The studies are non-clinical engineering and laboratory tests performed by the manufacturer, Dentsply Sirona. No specific country of origin or retrospective/prospective status is relevant as these are not human subject studies.

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):

• Not applicable. This is a 510(k) submission based on non-clinical data, not a study requiring expert consensus for diagnostic "ground truth." The "ground truth" is typically defined by engineering standards (e.g., ISO 14801 for fatigue limits, ISO 11137 for sterilization) and internal design specifications.

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

• Not applicable. Adjudication methods are used in clinical studies for interpreting human data or images amongst multiple readers. This document refers to non-clinical engineering tests.

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 physical dental implant component, not an AI-assisted diagnostic or treatment planning system for which human reader performance would be assessed.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" for the non-clinical tests is established by recognized international and industry standards, such as:
  • ISO 14801: Dentistry - Implants - Dynamic loading test for endosseous dental implants. This standard defines the method for fatigue testing.
  • ISO 11137-1/2: Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices.
  • ISO 17665-1/2: Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process.
  • ISO 11607: Packaging for terminally sterilized medical devices.
  • ASTM F1980: Standard Guide for Accelerated Aging of Sterile Medical Device Packages.
  • Internal engineering specifications and CAD models: For geometric compatibility and interface analysis.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this 510(k) submission as it is for a physical device, not a machine learning algorithm.

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

• Not applicable, as there is no training set for this type of device submission.

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