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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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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 Solution
• Ti base and
• CAD/CAM software
  Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants.

Telio CAD Abutment Solutions are resin blocks with an interface hole in Small and large sizes to accommodate Sirona Ti bases (K100152 and K111421) in the fabrication of temporary hybrid abutment crowns. The Device is milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns in coniunction with endosseous dental implants. Hybrid abutment crowns are characterized by combining a Ti base and monolithic crown in one piece.
Telio® CAD Abutment Solutions are CAD/CAM-fabricated implant-supported hybrid restorations for individual, temporary single-tooth reconstructions. The material consists of a cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base. Shape, esthetics and emergence profile can be easily designed and adjusted any time.

This document is a 510(k) premarket notification for a medical device called "Telio CAD Abutment Solutions." It focuses on demonstrating the substantial equivalence of the new device to previously marketed predicate devices. The information provided heavily emphasizes physical, mechanical, and biological testing rather than artificial intelligence or diagnostic algorithms. Therefore, many of the typical acceptance criteria questions related to AI performance, such as sensitivity, specificity, or AUC, as well as aspects like reader studies, are not applicable here.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes tests performed and states the results were "comparable to the predicate device" or "suitable for use." The focus is on demonstrating equivalence rather than meeting specific numerical thresholds for improved performance.

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

The document provides details on types of testing (flexural, fatigue, biocompatibility) and the standards used (EN ISO 10477:2004, EN ISO 14801:2007, ISO 10993-1, ISO 7504). However, it does not specify the sample sizes (e.g., number of test specimens) used for each of these mechanical tests. It also doesn't mention the provenance of any "data" in terms of country of origin or whether it was retrospective/prospective, as this is typically relevant for clinical data, which is not the primary focus of this submission. The testing appears to be laboratory-based physical/mechanical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable. The device is a dental abutment, and its performance is evaluated through physical, mechanical, and biocompatibility testing, not through a diagnostic algorithm requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This question is not applicable. There is no "test set" in the context of expert review or diagnostic output that would require an adjudication method. The testing described is laboratory-based.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This question is not applicable. MRMC studies are used to evaluate AI performance with human readers. This submission is for a physical medical device (dental abutment) and does not involve AI or human interpretation of diagnostic results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable. There is no algorithm or AI component mentioned in this submission. The device is a physical product.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through standardized laboratory testing and material characterization according to international ISO and EN standards. For example, flexural strength is measured directly, dynamic fatigue is assessed against defined cycles and loads, and biocompatibility is evaluated based on established biological safety protocols. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it would be for a diagnostic tool.

8. Sample Size for the Training Set

This question is not applicable. As there is no AI/machine learning algorithm involved, there is no "training set."

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

This question is not applicable. As there is no AI/machine learning algorithm involved, there is no "training set" or ground truth for such a set to be established.

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