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Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months).
The system comprises three parts:

• Telio CAD Abutment Solutions
• Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991)
• CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520)
  Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below:
  -Implant systems:
  The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems:
• AstraTech Osseospeed (Dentsply Sirona K130999, K091239)
• Frialit/Xive (Dentsply Sirona K013867))
• internal connection (BioHorizons K143022, K071638, K093321, K042429)
• Replace (Nobel Biocare K020646)
• Nobel Active (Nobel Biocare K071370)
• Bränemark® (Nobel Biocare K022562)
• Tissue Level (Straumann K061176)
• Tapered Screw-Vent (Zimmer K061410)
• Camlog Screw-Line (Camlog K083496)
• Conelog Screw-Line (Camlog K113779)
• iSy (Camlog K133991)
• Osstem TS (Osstem (USA: Hiossen) K121585)

The Telio® CAD Abutment Solutions- extra systems which is the subject of this premarket notification is a modification to the Telio Abutment Solutions as previously cleared under K151564. The modifications represented in the subject device consist of the addition of 14 extra implant systems to the 2 previously cleared implant systems. The device Telio CAD (K093708) is currently cleared by the FDA as a Crown and Bridge, Temporary Resin (21 C.F.R§872.3770) because it is a device that offers a rapid route to effective temporary restorations. The currently cleared Telio CAD Abutment Solutions (K151564) included the system Straumann Bone Level, but not all the parts of this system (i.e. NC) were mentioned. This submission includes 14 additional systems.
Telio CAD Abutment Solutions- extra systems is intended for use in single hybrid abutment crowns for temporary restoration (up to 12 months). Telio CAD Abutment Solutions is a system comprising of three parts: Telio CAD Abutment Solution, cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base, utilizing Sirona CAD/CAM System to design and fabricate long term temporaries by means of the CAD/CAM technique. The abutments being two-piece titanium base abutments are mated with a PMMA top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment.
For the fabrication of Telio CAD Abutment Solutions, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan, depending on the CAD/CAM system used. For notes regarding the scan, please observe the manufacturer's instructions for use of the CAD/CAM system.

Here's a breakdown of the acceptance criteria and study information for the Telio® CAD Abutment Solutions- extra systems device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Mechanical Properties (Flexural Strength, Water Sorption, etc.): The specific number of samples for each mechanical test (Flexural Strength, Water Sorption, Solubility, Flexural Modulus, and Ball Indentation Hardness) is not specified in the provided document. It only states that "Bench testing was performed" and "The subject device was tested in direct comparison to the predicate device."
• Sample Size for Dynamic Fatigue: The document states "The fatigue testing performed for the listed extra systems proves that Telio CAD Abutment Solutions can be used with the 14 additional implant systems." However, the exact sample size (number of devices tested for dynamic fatigue) for each implant system is not specified.
• Data Provenance: This information is not available in the provided document. The document refers to standards (EN 1641:2009, ISO 14801:2007) but does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

• This information is not applicable as the studies described are bench testing (mechanical and fatigue testing), which rely on objective measurements and established standards, rather than expert interpretation of data like in clinical trials or image analysis.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies described are bench testing.

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 information is not applicable. The device is a dental abutment system and not an AI-powered diagnostic or assistive tool for human readers.

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

• This information is not applicable. The device is a dental abutment system and does not involve an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the mechanical properties tests (Flexural Strength, Water Sorption, etc.), the "ground truth" is established by the specified standards (EN 1641:2009), which define the measurement methodologies and often acceptable ranges or comparisons to predicate devices.
• For the dynamic fatigue testing, the "ground truth" is defined by the standard ISO 14801:2007, which outlines the load and cycle requirements for endosseous dental implants. The goal is for the device to meet or exceed the performance specified in this standard.

8. The Sample Size for the Training Set

• This information is not applicable as the device is a dental abutment system and does not involve machine learning algorithms that require a training set.

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

• This information is not applicable for the reasons stated above.

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