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KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Compatible implant systems and TiBase are as follows.

The KATANA Zirconia ONE For IMPLANT mesostructure material (conforming to ISO 6872:2015) is a pre-sintered zirconia block to be used as the ceramic mesostructure component of a two-piece titanium base abutment. KATANA Zirconia ONE For IMPLANT is compatible with the specified TiBase and the CAD/CAM component of the Sirona Dental CAD/CAM system (K193408, K200191) as identified in the Indications for Use. This device is further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown.

The Zirconia block has identical composition as our own previously cleared reference device, KATANA Zirconia Block (K190436) under product code "EIH".

The mesostructure material of KATANA Zirconia ONE For IMPLANT is available in shades, A1, A2, A3, A3.5, B1, B2, C1, C2, D2 and NW for flexibility and application variety to meet individual patient needs. The mesostructure material of KATANA Zirconia ONE For IMPLANT is available with one block size and two sizes of access hole, which is small (S) and large (L).

The abutment must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component. PANAVIA SA Cement Universal (K183537) is used as the cement to set the mesostructure material to TiBase when the mesostructure material of the subject device set to TiBase prior to sterilization.

Dentsply Sirona has issued a letter of authorization indicating that the subject mesostructure material of the subject device can be selected in combination with the CAD/CAM system. Kuraray Noritake Dental and Dentsply Sirona have a business agreement for adding this new material to the Sirona CAD/CAM system. Kuraray Noritake Dental has worked with Dentsply Sirona to implement their new material into the Sirona CAD/CAM system libraries.

KATANA Zirconia ONE For IMPLANT which is the subject of this premarket notification consists of:

• Sirona Dental CAD/CAM System with CEREC Chairside Software or with inLab Software
• Sirona TiBase
• . KATANA Zirconia ONE mesostructured blocks

The provided text is a 510(k) summary for a dental device, specifically a zirconia block for implant mesostructures. It details the device's indications for use, design, material composition, and technical characteristics, comparing it to predicate and reference devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" sample size for a clinical study. The performance evaluation relied on non-clinical testing and comparison to predicate devices, referencing international standards and scientific literature.

• Data Provenance: The document does not specify a country of origin for any data beyond the manufacturer being in Japan. The studies are non-clinical, involving material testing and compatibility assessments. There is no mention of retrospective or prospective data as no human clinical testing was performed.

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

Not applicable. No human clinical testing was performed, and thus no expert ground truth was established for a clinical test set. The ground truth for material properties and performance would be derived from adherence to international standards and non-clinical testing protocols.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring human interpretation or adjudication was used, this information is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of the subject device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI algorithm. It is a physical dental material (zirconia block) used in a CAD/CAM system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance is related to the material's physical and mechanical properties, its compatibility with the CAD/CAM system, and its ability to meet structural requirements when fabricated into an abutment.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• International Standards: Adherence to established ISO standards for ceramic dental materials (ISO 6872:2015) and dynamic fatigue testing for dental implants (ISO 14801:2016).
• Material Composition: Verification of identical chemical composition to a previously cleared reference device (KATANA Zirconia Block, K190436).
• Biocompatibility Standards: Evaluation against ISO 10993 series and ISO 7405.
• Engineering Design Parameters: Validation against specified design parameters for abutment post height, angulation, wall thickness, diameter, and gingival height, consistent with CAD/CAM system requirements and FDA recommendations.
• Compatibility: Confirmation of functional compatibility with the predicate CAD/CAM system (Dentsply Sirona) and associated TiBase components through a business agreement and technical specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a physical material, not an AI/ML algorithm that requires a "training set."

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

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

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CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

• CEREC Cercon 4D™ Abutment Block
• TiBase
• CAD/CAM system

The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.

CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to theBase (Titanium base) used with dental implant systems.

The provided document describes the substantial equivalence of the CEREC Cercon 4D™ Abutment Blocks and System, primarily focusing on non-clinical performance and material characteristics, rather than an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and study that proves the device meets those criteria from the perspective of a medical device (specifically, a dental abutment system), even without AI elements.

Here's the information based on the provided text, with Not Applicable (N/A) for fields that relate to AI/ML studies and are not covered in this document.

Acceptance Criteria and Device Performance for CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System

The device under review is primarily a dental abutment system, and its performance is evaluated based on material properties, mechanical strength, and software integration, not on diagnostic accuracy or AI assistance.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size for Test Set:
  • For Flexural Strength (Table 8.1): Not explicitly stated, but typically involves a certain number of samples to ensure statistical significance as per ISO 6872.
  • For Fatigue Testing (Table 8.2): "New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations." The exact number of samples per test condition is not specified in the document, but standardized tests like ISO 14801 would stipulate a minimum.
  • For Sterilization Validation, Biocompatibility, and Software Validation: Not explicitly specified in terms of sample count in this summary.
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "non-clinical tests" and "performance bench testing," indicating laboratory-based studies. The document does not mention if the data is retrospective or prospective, as this distinction is more relevant for clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "ground truth" (or more accurately, established performance standards) for this device is based on mechanical properties and ISO standards, which are objective and do not require expert human interpretation in the way an AI diagnostic system would.

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

Not applicable, as no human expert interpretation or consensus review is involved in the performance testing of this device (e.g., physical strength, material composition).

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 is not an AI-assisted diagnostic device; therefore, MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm-based device. Its "system" aspect refers to the combination of the abutment block, TiBase, and CAD/CAM system for fabrication, not an AI algorithm. The performance described is of the physical components and the software's ability to constrain design parameters.

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

The "ground truth" for this device's performance is established by international consensus standards (e.g., ISO 6872, ISO 14801, ISO 10993, ISO 17665-1) for dental materials and implants, along with internal software integration requirements. These are objective, quantitative measures rather than subjective human interpretations or clinical outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device does not have a "training set" in the context of machine learning.

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

Not applicable. This device does not have a "training set" in the context of machine learning.

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The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

All digitally designed copings and/or crowns for use with the Straumann® TLX Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Straumann® TLX Variobase® C abutments are two-piece abutments composed of the following components:

• . Straumann® TLX Variobase® C (Ti-base)
• Prosthetic Restoration (patient specific coping or crown) .
• . Basal Screw

The Straumann® TLX Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platform: NT (Narrow TorcFit), RT (Regular TorcFit), and WT (Wide TorcFit). The Straumann® TLX Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half material that is compatible with the Straumann® TLX Variobase® C abutments is IPS e.max CAD.

The provided document is a 510(k) Summary for a dental device, the "Straumann® TLX Variobase® C". This document describes the device, its intended use, and how it compares to predicate devices. It does not describe a study involving an AI/ML algorithm or its performance characteristics.

Therefore, I cannot provide the information requested in your prompt because the document does not contain details about:

• Acceptance criteria for an AI/ML device.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test or training sets for an AI/ML model.
• Ground truth establishment methods for AI/ML data.
• Expert consensus or adjudication for AI/ML performance evaluation.
• MRMC studies for AI/ML or human-in-the-loop performance.
• Standalone AI algorithm performance.

The "Performance Testing" section (Page 10, section {10}) refers to mechanical and software validation testing for a dental abutment, not an AI/ML algorithm. Specifically, it mentions:

• Dynamic fatigue and static strength tests (mechanical performance).
• Biocompatibility (material safety).
• Sterilization process validation.
• Software verification and validation for the abutment design library to ensure it operates within specified design limitations.

The software validation mentioned is to ensure the design software for the dental abutment (Sirona Dental CAD/CAM System) correctly applies design restrictions, not to evaluate an AI's diagnostic or predictive performance.

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MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two- piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.

Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.

MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Tibase abutment are to be made from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC® (IS), designed and manufactured using Sirona CEREC SW version 4.6.1 software.

MIS Ti-base abutments are intended for use with the following MIS implants:

• C1 conical connection implant system
• V3 conical connection implant system
• SEVEN internal hex implant system
• M4 internal hex implant system
• Lance+ internal hex implant system

The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.

MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.

MIS Ti-base abutments are the bottom-half/base of a two-piece custom ceramic-titanium abutment consisting of a ceramic coping/mesostructure and a titanium base.

The top-half custom ceramic coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block, IPS e.max® CAD ceramic block, or from IPS e.max® CAD ceramic block or VITA ENAMIC® (IS) ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm for inCoris ZI and e.max materials and 0.8mm for VITA ENAMIC material.

It is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.

The subject, pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.

This document describes a 510(k) premarket notification for the MIS Ti-base abutment. This is an FDA submission for devices that are "substantially equivalent" to predicate devices, meaning they have the same intended use and similar technological characteristics. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrating this substantial equivalence through non-clinical performance data, rather than a clinical trial with specific performance metrics like sensitivity or specificity for an AI algorithm.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device (dental abutment) and not an AI algorithm, the "acceptance criteria" are related to demonstrating that the device performs as safely and effectively as a legally marketed predicate device. The performance is assessed through non-clinical testing against established standards.

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

• Sample Size for Test Set: The document does not specify a "test set" in the context of clinical data for AI. For the non-clinical fatigue testing, "worst case abutments" were chosen. The exact number of samples tested for each worst-case configuration (e.g., number of narrowest abutments, number of specific mesostructures) is not explicitly stated but implied to be sufficient for ISO 14801:2016 compliance.
• Data Provenance: Not applicable in the context of clinical or retrospective data for an AI algorithm. The performance data comes from laboratory non-clinical tests.

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

• This is not applicable as this is a non-clinical device submission for a physical component, not an AI algorithm requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable for a non-clinical device submission.

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 is not an AI-assisted diagnostic device.

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

• Not applicable. This device is a physical dental abutment. The software mentioned (CEREC SW version 4.6.1) is for design and milling, not a standalone AI diagnostic algorithm.

7. The Type of Ground Truth Used

• For fatigue testing, the "ground truth" is defined by the mechanical strength and durability requirements of the ISO 14801:2016 standard, ensuring the device can withstand chewing forces.
• For biocompatibility, the "ground truth" is adherence to ISO 10993-1 and prior clearances of materials used.
• For sterilization, the "ground truth" is effective sterilization as demonstrated by ANSI/AAMI/ISO 17665 standards.
• For software verification, the "ground truth" is the established design limitations and the software's ability to enforce them.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI algorithm that requires a training set. The software mentioned (CEREC SW) is a CAD/CAM design software, not a machine learning model developed with a training set.

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

• Not applicable as there is no training set for an AI algorithm.

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The Straumann® Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

All digitally designed copings and/or crowns for use with the Straumann® Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Straumann® Variobase® C abutments are two-piece abutments composed of the following components:

• . Straumann® Variobase® C (Ti-base)
• . Prosthetic Restoration (patient specific coping or crown)
• . Basal Screw

The Straumann® Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platforms: RC (Regular CrossFit®), NC (Narrow CrossFit®), NNC (Narrow Neck CrossFit®), RB/WB(Regular Base/Wide Base), and WB (Wide Base). The Straumann® Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half materials that are compatible with the Straumann Variobase C abutments include IPS e.max CAD, inCoris ZI, and n!ce. The top half material compatibility is dependent on the dental implant platform, with inCoris Zl and n!ce only being compatible with the RC (Regular CrossFit®) and NC (Narrow CrossFit®) platforms.

The provided text describes a 510(k) premarket notification for a dental device, the "Straumann® Variobase® C." It details the device's characteristics, intended use, indications for use, and a comparison to predicate devices. The section titled "Performance Testing 1.8" provides information on the studies conducted to demonstrate the device meets acceptance criteria.

Here's an analysis of the provided information against your requested criteria:

Based on the provided text, there is no information related to an AI/ML-based medical device performance study. The device described, Straumann® Variobase® C, is a dental abutment, which is a physical component used with dental implants. The performance testing mentioned (Dynamic fatigue and static strength tests, biocompatibility, sterilization process) are standard pre-market tests for physical medical devices and do not involve AI/ML.

Therefore, I cannot fulfill your request for details on:

1. A table of acceptance criteria and reported device performance (for AI/ML): The document doesn't provide this for an AI/ML device. The performance tests are for mechanical properties and sterility.
2. Sample sizes used for the test set and data provenance: Not applicable in the context of AI/ML. The provided text refers to physical testing (e.g., fatigue tests, which would have sample sizes for individual abutments).
3. Number of experts used to establish ground truth and qualifications: Not applicable, as there's no AI/ML model requiring ground truth from experts. The software mentioned (Sirona CEREC Software) is a CAD/CAM design software, not an AI diagnostic tool.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not done, as there's no AI component for human readers to interact with.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of relevant information from the document (not AI/ML related):

• Device Type: Endosseous Dental Implant Abutment (physical component)
• Performance Tests Mentioned:
  • Dynamic fatigue and static strength tests (according to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments").
  • Biocompatibility (stated that materials are identical to predicate, so no new issues).
  • Sterilization process validation (according to FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1, ISO 17665-2).
• Conclusion of Performance Testing: "demonstrated that the Straumann Variobase C abutments are equivalent to the predicate and reference devices." This implies the device meets the performance characteristics of previously cleared similar devices.

In conclusion, the provided FDA 510(k) summary document pertains to a physical dental implant abutment and does not contain information about an AI/ML medical device or its acceptance criteria and study proving its performance.

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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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CEREC Guides are intended to support the dentist or oral surgeon when drilling for placement of dental implants. CEREC Guides are intended to be designed and fabricated using the Sirona Dental CAD/CAM System's CEREC Chairside software and CAM equipment, Galileos Implant dental implant planning software, and Calibra Universal Self-Adhesive Resin Cement.

The CEREC Guide dental surgical guides are milled poly(methyl methacrylate) [PMMA] devices which are designed and fabricated utilizing the Sirona Dental CAD/CAM System with CEREC Chairside Software (K181520) and are intended to act only as dental implant placement templates. The CEREC Guides are designed in the Sirona Dental CAD/CAM System's CEREC Chairside Software utilizing, as an input, a completed dental implant treatment plan which is developed in the "Galileos Implant treatment planning software as cleared under premarket notification K093090.

The CEREC Guide surgical guides are offered in two variants, the CEREC Guide 2 and CEREC Guide 3. Both the CEREC Guide 2 and CEREC Guide 3 are milled from the CEREC Guide Bloc milling blocks. The CEREC Guide Blocs are clear, PMMA blocks intended for milling utilizing the CEREC MC XL family of milling units. CEREC Guide Blocs are offered in two size variants, "medi" and "maxi".

The CEREC Guide 2 surgical guides consist of the surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. The CEREC Guide 2 surgical guides are used in conjunction with CEREC Guide Drill Keys. CEREC Guide Drill Keys are stainless steel, reusable drill guide instruments which are offered in variants with internal diameters ranging from 2.0 mm to 4.85 mm.

The CEREC Guide 3 surgical guides consist of the CAD/CAM surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. CEREC Guide 3 surgical guides feature integral titanium guide sleeves that are bonded the CEREC Guide 3 surgical guide body using Dentsply Sirona Calibra® Universal adhesive (K073173). The CEREC Guide 3 Guide Sleeves are single use and are offered in 4 size variants, with outer diameters ranging from 5.5 mm to 6.0 mm, and internal diameters ranging from 4.48 mm - 5.2 mm.

The provided FDA 510(k) premarket notification for "CEREC Guides" focuses on demonstrating substantial equivalence to a predicate device ("SIMPLANT Guide," K170849) through non-clinical performance data. It does not involve a multi-reader multi-case (MRMC) study or artificial intelligence (AI) performance evaluation. Therefore, many of the requested elements for an AI-based device, such as ground truth establishment by experts, adjudication methods, and MRMC study details, are not applicable here.

Here's a breakdown of the available information relevant to acceptance criteria and study proving device performance:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with specific numerical thresholds and corresponding performance results in the format requested, typical for AI/ML device submissions. Instead, it describes various non-clinical tests conducted to support substantial equivalence. The "acceptance criteria" are implied by the successful completion of these validation tests.

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

The document describes non-clinical bench and validation tests rather than a test set of patient data. Specific sample sizes for these engineering and material tests (e.g., number of guides milled for accuracy, number of drill sleeves tested for retention) are not detailed in this summary. The data provenance is from the manufacturer's internal testing as part of the regulatory submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on non-clinical engineering and performance testing, not on interpretative performance (like image reading) where expert ground truth is typically established. The "ground truth" for the device's function is its design specifications and physical properties, tested through controlled experiments.

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

Not applicable. There's no human adjudication process described, as it's not a study evaluating human interpretation or AI output against a consensus.

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

No MRMC study was done. This device, CEREC Guides, is a physical, milled surgical guide, not an AI or software-assisted diagnostic tool that would typically undergo an MRMC study to assess reader performance. The submission explicitly states: "No human clinical data was included in this premarket notification to support the substantial equivalence of the subject CEREC Guides."

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

Not applicable. This is not an AI algorithm. Its performance is evaluated based on its physical properties, manufacturing accuracy, and integration with existing approved software and hardware. The "device" itself is the physical CEREC Guide.

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

The "ground truth" for the performance tests is based on:

• Design Specifications and Reference Standards: The intended design dimensions and functionalities derived from the Galileos Implant treatment planning software served as the reference for accuracy testing.
• Established Material Properties and Biocompatibility Standards: ISO standards (e.g., ISO 10477, ISO 10993-1) and published literature for material strength and biocompatibility served as the benchmark.
• Validated Disinfection Protocols: FDA and industry guidelines for high-level disinfection processes.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment for a training set.

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IPS e.max® CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

• IPS e.max CAD ceramic structure
• Ti base
• CAD/CAM system.

The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The compatible Implant systems, titanium bases and CAD/CAM systems are shown below: -Implant Systems:

• Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867)

• BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429),

• Osstem: TS Implant System (K121585)

• Straumann: Tissue Level RN/WN (K061176)

• Nobel Biocare: Branemark (K022562)

• Zimmer: Tapered Screw-Vent (K061410)

• Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991)

• CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520)

-Titanium Bases: Dentsply Sirona TiBase, Camlog TiBase

The IPS e.max® CAD Abutment Solutions- extra systems Device Description: which is the subject of this premarket notification is a modification to the IPS e.max CAD Abutment Solutions as previously cleared under K132209. The modifications represented in the subject device consist of the addition of 11 extra Ti-Bases to the 4 previously cleared Ti-Base compatibilities.

IPS e.max CAD Abutment Solutions- extra systems is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. IPS e.max CAD Abutment Solutions is a system comprising IPS e.max CAD ceramic structure, Sirona TiBase and Sirona CAD/CAM System to design and fabricate the ceramic structure. The abutments being two-piece titanium base abutments are mated with a ceramic top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment.

For the fabrication of IPS e.max CAD Abutment Solutions and depending on the CAD/CAM system used, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan. Updated material and TiBase library datasets relating to Sirona Dental CAD/CAM System with CEREC chairside software are obtained by download at: https://my.cerec.com.

IPS e.max CAD Abutment Solutions are lithium disilicate blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already included in the shipped block. The connection geometry fit select Titanium Bases as identified in the Indications for Use. The mesostructured is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown. The device serves as the esthetic mesostructured which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.

The document describes the regulatory submission for the IPS e.max® CAD Abutment Solutions- extra systems (K191382). This device is a modification of a previously cleared device (K132209) and primarily focuses on the addition of new compatible titanium bases for various implant systems.

The acceptance criteria and study information are derived from the "Testing Summary" and "Conclusion" sections.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily discusses the substantial equivalence of the modified device to its predicate, focusing on adding new compatible implant systems. The primary performance characteristic assessed is fatigue strength.

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

The document states, "The fatigue testing performed for the listed extra systems proves that IPS e.max CAD Abutment Solutions can be used with the 11 additional implant systems." However, specific sample sizes (e.g., number of test specimens per implant system) are not explicitly provided in the provided text for the fatigue testing. The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The type of testing described (dynamic fatigue) is a bench-top mechanical test, not reliant on expert evaluation for ground truth in the traditional sense of clinical studies.

4. Adjudication Method for the Test Set:

This information is not applicable as the described testing is a bench-top mechanical fatigue test, not a clinical study involving human readers or interpretation requiring adjudication.

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 is not applicable. The device is an endosseous dental implant abutment system, 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 is not applicable. The device is a physical medical device (dental abutment system), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation in this context is based on mechanical endurance testing (fatigue strength) as defined by the ISO 14801:2007 standard.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reason as above.

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