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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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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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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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The Klockner Vega TiBase for CEREC® abutments are titanium alloy abutments placed onto Klockner Vega Implants to provide support for customized prosthetic restorations. The Klockner Vega TiBase for CEREC® 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 Klockner Vega TiBase for CEREC® abutments are to be designed and milled using Sirona CEREC Premium SW 4.2 software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Klockner Vega TiBase for CEREC® abutments are two-piece abutment (composed of the ti-base component and a ceramic mesostructure or coping) fabricated by using the Sirona Dental CAD/CAM System and are to be used with Klockner Vega Dental Implant Systems, with conical and hexagonal internal connection, platforms MV, NV, RV. The Klockner Vega TiBase for CEREC® are Ti-base abutments, made of titanium alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC® systems, and the base portion is available in three models to fit three Klockner® dental implant platforms.

The provided text is a 510(k) summary for the Klockner Vega TiBase for CEREC®. This document is primarily concerned with establishing substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a detailed performance study where "acceptance criteria" refers to the thresholds of performance for an AI/CADe device.

Therefore, the provided document does not contain the information requested for acceptance criteria and a study proving device meets those criteria, particularly in the context of an AI/CADe device. The Klockner Vega TiBase for CEREC® is a physical dental implant abutment, and its approval process focuses on bench testing (dimensional verification, dynamic fatigue, bending assays) and biocompatibility, as well as demonstrating equivalence to predicate devices, rather than statistical performance metrics like sensitivity, specificity, or reader improvement seen with AI/CADe devices.

The "bench testing" mentioned in the document is for mechanical properties and fit, not for statistical performance metrics against a ground truth as would be the case for an AI/CADe system.

Specifically, the document states:

• No clinical data are included in this submission. This immediately indicates that no study involving human subjects or real-world patient outcomes (which would be necessary for ground truth establishment and performance metrics) was conducted or provided.
• The discussions are centered on substantial equivalence to predicate devices based on indications for use, materials, design features, and manufacturing workflow, not on a new performance evaluation against defined acceptance criteria for an AI/CADe.
• Bench testing is mentioned for dimensional verification and dynamic fatigue/bending assays, which are engineering tests for a physical device, not performance studies for an AI algorithm.

In summary, none of the requested information regarding acceptance criteria, study design for AI/CADe performance, sample sizes for test/training sets, expert readers, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/CADe device is present in this document.

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The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
• Link abutment for CEREC
All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

The Link Abutment for CEREC provide the interface for mesostructure designed and milled using the Sirona CEREC system with HIOSSEN Implant System (K140934) The Link Abutment for CEREC is pre-manufactured (stock) abutment made from a titanium alloy (ASTM F 136). The Link Abutment for Cerec is a Ti-base abutment design consisting of the Link Abutment and Sirona ceramic mesostructure. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems.

This document is a 510(k) premarket notification for a dental device, the "Link Abutment for CEREC." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study for acceptance criteria of an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance and ground truth establishment is not available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present "acceptance criteria" in the typical sense of metrics for an AI/ML device. Instead, it demonstrates substantial equivalence through comparisons of design, materials, indications for use, and non-clinical testing. The "reported device performance" is primarily in the context of mechanical properties and safety.

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

• This document describes non-clinical performance testing (fatigue, sterilization) of a physical dental device, not an AI/ML algorithm. Therefore, there isn't a "test set" of data in the AI/ML sense. The "sample size" would refer to the number of physical abutment samples tested. This specific number is not provided in the document, but it states "fatigue testing was considered... with the worst case scenario."
• Data provenance: Not applicable in the AI/ML context. The document refers to testing of the physical medical device and reference to predicate devices. The manufacturer is OSSTEM Implant Co., Ltd. from Busan, Republic of Korea.

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

• Not applicable as this is not an AI/ML device study. Ground truth, in this context, would relate to the established engineering standards and specifications for dental abutments.

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

• Not applicable as this is not an AI/ML device study. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done because this is a physical dental abutment, not an AI/ML diagnostic or assistive device.

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

• No, a standalone algorithm performance study was not done because this is a physical dental abutment, not an AI/ML algorithm.

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

• The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science standards (e.g., ASTM F 136 for titanium alloy, ISO 17665-1:2006 for sterilization), and comparison to predicate devices that have already demonstrated safety and effectiveness through their prior clearances (K120847, K151324). It's essentially a demonstration of conformance to pre-defined physical and mechanical properties and established clinical use for dental abutments.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device and therefore does not have a training set.

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

• Not applicable as this is not an AI/ML device and therefore does not have a training set.

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The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® 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® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Straumann® Variobase® for CEREC® abutments provide the interface for copings or crowns designed and milled using the Sirona CEREC system with four of the Straumann dental implant platforms: RN (Reqular Neck), WN (Wide Neck), RC (Regular CrossFit®), and NC (Narrow CrossFit®). The Straumann® Variobase® for CEREC® 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 CEREC MC X and MC XL prosthetic milling systems, and the base portion is available in four models to fit the four Straumann® dental implant platforms listed above.

The provided text is a 510(k) summary for the Straumann® Variobase® for CEREC® abutments. It details the device, its intended use, and comparative analysis with predicate devices, along with performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided (or absence thereof):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of explicit, pre-defined acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy, which are common for AI/diagnostic devices. Instead, it demonstrates "substantial equivalence" to predicate devices through various performance tests.

Here's what can be inferred about the performance goals and the results reported:

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

The document does not explicitly state sample sizes for specific tests in terms of number of cases, patients, or data points in a way that would be typical for an AI-driven diagnostic.

• Dimensional verification: "CEREC® e.max blocks" are mentioned, implying physical components were tested, but no number is given.
• Dynamic fatigue testing: "Worst case dynamic fatigue testing" is mentioned, implying a specific test methodology, but the sample size (e.g., number of abutments tested) is not provided.
• Process validation: Relates to the workflow, not a data set.
• Sterilization validation: Refers to compliance with standards, not performance on a data set.

The provenance of data is not applicable in the context of this device, as it's a dental implant abutment, not a data-driven diagnostic or AI device. The testing focuses on physical and functional characteristics.

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

This information is not applicable. The device is a physical dental hardware component (abutment) and its compatibility with a CAD/CAM system, not an AI or diagnostic application requiring expert review for ground truth establishment. The "ground truth" for the performance tests would be objective measurement standards (e.g., ISO for sterilization, mechanical testing standards for fatigue).

4. Adjudication Method for the Test Set

This information is not applicable as the device is not an AI/diagnostic device. Performance tests involve objective measurements and adherence to standards, not subjective expert adjudication.

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

This information is not applicable. The device is a physical medical device (dental abutment), not a diagnostic or AI system that human readers would interact with. Therefore, there's no "human readers with/without AI assistance" scenario.

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

This information is not applicable. The device is a physical component, not an algorithm. The "algorithm" aspect refers to the Sirona CAD/CAM software used to design the copings/crowns that interface with the abutment, and the document clarifies that the device (abutment) is compatible with existing, cleared software versions. The abutment itself does not perform any algorithmic function.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing consists of:

• Physical Fit Standards: For dimensional verification (e.g., CAD specifications, manufacturing tolerances).
• Mechanical Performance Standards: For dynamic fatigue testing (e.g., ISO standards for dental implants and prosthetics that define minimum required fatigue properties).
• Process Standards: For process validation (Sirona CEREC InLab workflow parameters).
• Sterilization Standards: For sterilization validation (ISO 17665-1, ISO/TR 17665-2, ANSI/AAMI ST79).

8. Sample Size for the Training Set

This information is not applicable. The device is a physical dental abutment, not an AI algorithm that requires a training set. The reference to Sirona software versions (3.65 and 4.2 or higher) indicates compatibility with existing, validated software, not training a new model.

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

This information is not applicable as there is no training set for this physical device.

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The Straumann® CARES® Variobase™ Abutment is a two-piece dental abutment consisting of the Straumann® Variobase™ Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. Straumann® CARES® Variobase™ Abutments are indicated for screw-retained single tooth and bridge restorations.

The Straumann® CARES® Variobase™ Coping polycon® ae in combination with the Straumann® Variobase™ Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.

The Straumann® CARES® Variobase™ portfolio consists of different parts which are used to provide prosthetic rehabilitation of a dental implant.

Premanufactured Variobase™ Abutments are available for the different platforms of the Straumann® dental implant system. These serve as a bonding base to which a patientspecific coping can be cemented. The coping can be made from ceramics to result in a permanent restoration, or made from acrylics to result in a temporary restoration (up to 180 davs).

The coping can be fully anatomical, i.e. it is a replica of a tooth with incisal edge or occlusal surface. It may also be of a reduced tooth shape in which case a separate crown needs to be cemented onto the coping or direct veneering needs to be applied.

Straumann® Variobase™ Abutments are bonding bases made from a titanium-aluminumniobium alloy. They are standard medical devices (stock produced).

Straumann® CARES® Variobase™ Copings is patient-specific medical devices, i.e. they are designed for an individual patient.

Straumann® CARES® Variobase™ Copings are designed either by a wax-up or a "CADup" procedure. Either way is processed through Straumann's CAD system consisting of the table top 3D-scanner Straumann® CARES® Scan CS2 and the corresponding CAD software Straumann® CARES® Visual. (CAD: Computer Aided Design)

In a wax-up procedure a wax model of a coping is created and scanned to be able to CAM produce the coping from a selected material. (CAM: Computer Aided Manufacturing)

In a "CAD-up" procedure, scanned data is used as the source to digitally design a coping. The design data is then sent to a Straumann milling center. The Straumann® CARES® Variobase™ Copings are CAM produced at the Straumann milling center according to the design file received and from the selected material.

The provided text describes the 510(k) premarket notification for "Straumann® CARES® Variobase™ Abutments." Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "Bench testing was performed to evaluate the fatigue load limits" and "Dynamic fatique tests were carried out," but it does not specify the exact sample size (number of abutments/copings tested).
• Data Provenance: The tests were conducted internally by Straumann AG as part of their 510(k) submission. The document does not explicitly state the country of origin of the data beyond "Institut Straumann AG Peter Merian-Weg 12 CH-4052 Basel Switzerland." The study is prospective in the sense that the testing was performed specifically to evaluate this device for regulatory submission.

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

This device appears to be a physical dental prosthetic component. The acceptance criteria and performance evaluation are based on engineering and material science standards (e.g., ISO for materials, FDA Guidance for dynamic fatigue tests), rather than qualitative assessment of images or clinical outcomes by human experts on a 'test set' in the way one might evaluate AI performance for medical imaging. Therefore, the concept of "experts used to establish ground truth" with specific qualifications for a test set, as applied to AI/imaging studies, is not applicable here. The ground truth for mechanical testing is derived from established engineering test protocols and performance metrics.

4. Adjudication Method for the Test Set

As explained in point 3, the evaluation of this device involves bench testing against predefined engineering standards. An "adjudication method" involving multiple human readers (e.g., 2+1, 3+1) is not applicable for this type of performance testing. The results are quantitative measurements against established pass/fail criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers, with and without AI assistance, on a set of cases. The submission focuses on the mechanical and material performance of a dental prosthetic device, not on diagnostic accuracy involving human interpretation of clinical cases.

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

While the device involves CAD/CAM software ("Straumann® CARES® Visual"), the performance testing described is for the physical prosthetic components (abutments and copings) rather than the standalone performance of an algorithm to, for example, diagnose a condition or predict an outcome. The CAD software's validation ensures it can design prosthetics that meet specifications, but this is a different type of "standalone performance" than an AI algorithm in a diagnostic context. The core performance testing here is physical bench testing of the device itself.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance is based on:

• Established engineering standards and guidance documents: Specifically, "FDA's Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for dynamic fatigue tests and "ISO 5832-11" for material properties.
• Pre-defined acceptance criteria: These criteria are derived from the aforementioned standards, specifying the thresholds for parameters like fatigue load limits.

8. The Sample Size for the Training Set

This product is a physical dental prosthetic, not an AI algorithm trained on a dataset. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The CAD/CAM software itself would have been developed and validated through its own processes, but details regarding a "training set" for that software are not provided in this document as it pertains to the physical device's performance testing.

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

As stated in point 8, the concept of a "training set" for this physical device is not applicable. For the CAD software, while not explicitly detailed for this product, ground truth for CAD/CAM systems is typically established through:

• Engineering specifications and tolerances: Defining the precise dimensions, shapes, and material properties required for the designed components.
• Physical prototypes and verification: Creating and testing physical models to ensure they match the digital design and meet functional requirements.
• Industry standards and clinical requirements: Ensuring the digital designs conform to established norms for dental prosthetics.

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