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The Sirona Dental CAD/CAM System with InLab Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S, SSO 3.5 L and 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. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructures may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems and sizes follows).

The Sirona Dental CAD/CAM System with InLab Software is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of functionality for the control of critical CAD/CAM abutment dimensions. The subject Sirona Dental CAD/CAM System with InLab Software consists of: InLab SW version 18.5, "labside" CAD/CAM software, InEos X5 3D digital desktop scanner, InEos Blue 3D digital desktop scanner, InLab MC X5 milling unit, InLab MCXL milling unit, Sirona TiBase titanium base components, inCoris ZI zirconium mesostructure blocks. The system is utilized to digitally acquire and/or record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components and the zirconium ceramic mesostructure component which is designed using the InLab software and milled using the InLab milling equipment. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement.

The provided text is a 510(k) Premarket Notification from Dentsply Sirona for their Sirona Dental CAD/CAM System with InLab Software. This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance data for a novel artificial intelligence algorithm.

Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, data provenance, number of experts, MRMC study, standalone performance, training set details) are not applicable or not present in this type of FDA submission.

This document indicates that the device is a modification to an already cleared system (K111421), and the current submission (K200191) focuses on bringing the "labside" variant (InLab software) into equivalency with a previously cleared "chairside" variant (CEREC software, K181520), which already incorporated the software design limitation controls.

Here's an analysis based on the provided text, addressing what information is available and what is not:

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

• Acceptance Criteria/Performance: The document does not provide a quantitative table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy, which would be typical for an AI/algorithm-based diagnostic device.
• Instead, the "acceptance criteria" are implied by the regulatory standards and successful validation against those standards. The performance is assessed by showing conformity to these standards and the equivalence of its function and safety to the predicate device.
  • IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance.
  • IEC 60601-1-2: Medical electrical equipment - Electromagnetic compatibility.
  • IEC 62304: Medical device software - Software lifecycle processes.
  • Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices (May, 2005).
  • "Software verification and validation testing was conducted to demonstrate that the software's design restrictions prevent design of the mesostructure component outside of design limitations, including screenshots under user verification testing." This indicates functional performance testing, where the "acceptance" is that the software correctly restricts design parameters.
  • "the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library." This confirms data integrity and adherence to design specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated in terms of patient data or case numbers. The testing appears to be on the device's functional and safety aspects (e.g., software function, electrical safety), not a clinical dataset of patient images or outcomes.
• Data Provenance: Not applicable in the context of device functional testing. There's no indication of patient data being used for "testing" in the sense of a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This document describes a CAD/CAM system for designing dental abutments, not a diagnostic AI system requiring expert-derived ground truth from medical images. The "ground truth" here relates to the engineering specifications and design limitations of the dental abutment, which are inherent to the software's programming and validated through functional testing.

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

• Not applicable. No clinical image-based adjudication process is described as this is not a diagnostic imaging AI.

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. An MRMC study is not mentioned. This is a CAD/CAM system for manufacturing dental prosthetics, not a system providing AI assistance to human readers for diagnostic interpretation.

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

• The document implies the software, as a component of the system, operates in a "standalone" fashion in terms of its internal logic for design limitations. However, the overall device (Sirona Dental CAD/CAM System) is inherently human-in-the-loop, as dentists and lab technicians use it for design and manufacturing. The focus of the validation is on the software's ability to enforce design restrictions automatically.

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

• The "ground truth" for the software's performance is based on engineering specifications and design limitations for dental abutments. These limitations are programmed into the software and verified to be unmodifiable and correctly enforced.
• This is not clinical ground truth derived from patient data or expert consensus on clinical findings.

8. The sample size for the training set

• Not applicable. This CAD/CAM system's software (InLab Software) is not described as utilizing a machine learning or deep learning algorithm that requires a "training set" in the conventional sense of AI. It's a design and manufacturing software, where "training" would refer to its development and programming against predefined dental design rules, not learning from data samples.

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

• Not applicable. As no training set is mentioned for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The software's functionality is based on established dental design principles and manufacturing parameters, which are encoded into its programming.

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The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and 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. The system consists of three major parts: TiBase, inCoris mesostructure and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems follows in the document)

The Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K181520. The modified Sirona Dental CAD/CAM System with CEREC Chairside Software that is the subject of this premarket notification includes a line extension to the existing offerings. These additional TiBase variants facilitate compatibility with currently marketed dental implant systems.

The modified Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification consists of:

• CEREC SW "chairside" CAD/CAM software
• CEREC AC digital acquisition unit
• CEREC AC Connect digital acquisition unit
• CEREC Omnicam 3D digital intraoral scanner
• CEREC MCXL product family of CAM milling units
• Additional Sirona TiBase titanium base components (line extension subject to this submission) compatible with Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 implants.
• inCoris ZI zirconium mesostructure blocks

As subject to this premarket notification, the Sirona Dental CAD/CAM System with CEREC Chairside Software is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of prefabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system.

As subject to this premarket notification, the subject Sirona Dental CAD/CAM System with CEREC Chairside Software is modified to include a line extension to the existing TiBase offerings by introducing TiBases which are compatible with the Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 dental implants.

The CEREC SW CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium/zirconia block materials.

The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for the design and fabrication of two-piece, CAD/CAM dental abutments.

Here's a breakdown of the acceptance criteria and the study information for the Sirona Dental CAD/CAM System with CEREC Chairside Software, based on the provided text:

Preamble: This 510(k) submission, K193408, is for a modification to an existing device (Sirona Dental CAD/CAM System, K181520), specifically a line extension for additional TiBase variants to facilitate compatibility with more dental implant systems. Therefore, the "study" described is primarily focused on demonstrating that the new variants perform comparably to the previously cleared predicate, rather than a de novo clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number for each test. The dynamic fatigue testing mentions "test sample constructs," implying multiple items were tested, but a precise number is not provided.
• Data Provenance: This is non-clinical performance data. The location of the testing is not specified, but it would have been generated by Dentsply Sirona or a contracted testing lab. It is inherently prospective data, generated specifically for this submission to demonstrate the performance of the new TiBase variants.

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

• Not Applicable. This submission is for a medical device (dental CAD/CAM system components), not an AI/imaging diagnostic device that requires expert review for ground truth establishment. The "ground truth" here is based on engineering specifications, material properties, and standardized performance tests (e.g., ISO 14801).

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical performance testing of physical components and software functionality, there is no expert adjudication process involved in the same way as for diagnostic AI outcomes. The performance is assessed against established engineering standards and design specifications.

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. An MRMC comparative effectiveness study was not performed. This device is a CAD/CAM system for fabricating dental abutments, not an AI diagnostic tool used by human readers to interpret medical images.

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

• Yes, indirectly. The performance tests described (geometric compatibility, dynamic fatigue, biocompatibility, sterilization validation, software integration) evaluate the device's performance in a standalone manner, separate from its use by a human operator in a clinical setting for diagnosis. The software component, specifically, underwent system integration testing to validate its requirements and functionality for designing the mesostructure, which is a standalone algorithm function.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Results:
  • Geometric compatibility: Original manufacturer's implant geometry specifications.
  • Dynamic fatigue: Adherence to ISO 14801 standards for dental implants.
  • Biocompatibility: Previous clearance (K181520) and established material properties.
  • Sterilization: Adherence to ISO 17665-1 and ANSI/AAMI ST79 standards.
  • Software integration: System requirements and design controls.

8. The Sample Size for the Training Set

• Not Applicable (or not provided in the document). This device is a CAD/CAM system modification, not an AI model that requires a training set in the typical machine learning sense. The software component is likely developed using traditional software engineering principles and validated through integration testing.

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

• Not Applicable. See point #8.

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The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S. SSO 3.5 L and 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. The system consists of three major parts: TiBase. inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems follows).

The Sirona Dental CAD/CAM System which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of a new "chairside" CAD/CAM software version, CEREC SW version 4.6.1, in which additional functionality for the control of critical CAD/CAM abutment dimensions has been added. Additionally, the modified Sirona Dental CAD/CAM System that is the subject of this premarket notification includes a line extension to the existing offerings of the Sirona TiBase titanium base component offerings. These additional TiBase variants facilitate compatibility with additional implant systems. The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification consists of: CEREC SW version 4.6.1, "chairside" CAD/CAM software; CEREC AC digital acquisition unit; CEREC AC Connect digital acquisition unit; CEREC Omnicam 3D digital intraoral scanner; CEREC MCXL product family of CAM milling units; Sirona TiBase titanium base components; inCoris ZI zirconium mesostructure blocks. As subject to this premarket notification, the Sirona Dental CAD/CAM System is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system. The CEREC SW 4.6.1 CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW 4.6.1 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium block materials. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement in order to complete the finished, two-piece CAD/CAM dental abutment.

Here is the information about the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K111421) rather than explicitly detailing numeric acceptance criteria for each test. However, it lists the types of non-clinical performance data and states that the results support substantial equivalence. The implied acceptance criterion for all tests is "conformity" with the referenced standards or successful validation/analysis, and the reported performance is that these criteria were met.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of abutments for fatigue testing, number of software test cases). It refers generally to "testing" and "analyses."

The data provenance is implied to be internal testing conducted by Dentsply Sirona, as the document details their testing efforts to support the 510(k) submission. No information about country of origin of the data is provided, nor whether it was retrospective or prospective, although typically such a submission would involve prospective testing designed to meet the specified standards.

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

This information is not provided in the document. The document describes compliance with recognized standards and internal validation processes but does not detail the involvement of external experts for establishing ground truth on a test set.

4. Adjudication Method for the Test Set:

This information is not provided. The non-clinical testing appears to rely on objective measurements against established engineering and regulatory standards rather than subjective expert adjudication of results.

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

No MRMC comparative effectiveness study was done or reported. This device is a CAD/CAM system for designing and fabricating dental abutments, not an AI or imaging diagnostic tool that would typically involve human reader performance studies.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study in the form of non-clinical performance data and software verification and validation testing was performed. The document describes:

• Testing to verify conformity with various IEC and ISO standards for medical electrical equipment, electromagnetic compatibility, and dynamic loading.
• Compatibility analyses of new TiBase interface geometries.
• System validation testing for the CAD/CAM software's design and fabrication workflow.
• Software verification and validation testing specifically for the abutment design library to demonstrate design restrictions and locked specifications.

These tests focus on the technical performance and safety of the device components and software, independent of human clinical application for their evaluation.

7. Type of Ground Truth Used:

The ground truth used for non-clinical testing is based on:

• Engineering specifications and design requirements: For confirming the functionality and outputs of the CAD/CAM system and software.
• Recognized international standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 62304, and ISO 14801 which define performance benchmarks and safety criteria.
• Original manufacturer's implant connection geometries: For compatibility analyses of TiBase interfaces.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Sirona Dental CAD/CAM System, as described, is not an AI/ML-based diagnostic device that typically requires a "training set" in the context of machine learning model development. It's a system for computer-aided design and manufacturing within predetermined parameters.

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

This information is not applicable, as there is no mention or indication of a "training set" for an AI/ML model for this device. The software functions based on established CAD/CAM principles and predefined parameters rather than learning from a training dataset.

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The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implants systems:

• Nobel Biocare Replace (K020646) .
• Nobel Biocare Branemark (K022562)
• Friadent Xive (K013867) ●
• . Biomet 3i Osseotite (K980549)
• Astra Tech Osseospeed (K091239) ●
• . Zimmer Tapered Screw-Vent (K061410)
• . Straumann SynOcta (K061176)
• Straumann Bone Level (K053088, K062129, K060958) .
• Biomet 3i Certain (K014235, K061629) .
• . Nobel Biocare Active (K071370)

The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.
The system that features the processing of mesostructures comprises

• Titanium bases TiBase and Camlog .
• . inCoris ZI meso blocks
• Sirona Dental CAD/CAM Design and fabricating devices .

This is a 510(k) premarket notification for a dental device, not a study evaluating performance against acceptance criteria with a test set and ground truth. Therefore, many of the requested elements (acceptance criteria table, sample size, data provenance, expert adjudication, MRMC study, standalone performance, training set details) are not applicable or not explicitly stated in the provided document.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, indications, construction materials, principles of operation, features, and technical data.

Here's the relevant information that can be extracted:

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

Since this is a 510(k) submission and not a performance study against specific acceptance criteria, a table directly outlining clinical acceptance criteria and device performance is not provided in this format. The "performance" is implicitly demonstrated through the device's technical specifications aligning with those of the predicate devices and existing standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. This document does not describe a clinical performance study with a test set. It describes non-clinical testing for material properties and mechanical fatigue.
• Data Provenance: Not applicable for a clinical test set. Nonclinical testing implicitly performed by the manufacturer, Sirona Dental Systems GmbH (Germany).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There was no clinical test set for which ground truth would be established by experts.

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

• Not applicable. There was no clinical test set 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

• Not applicable. This is a dental CAD/CAM system for fabricating restorations, 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 is a CAD/CAM system, which involves human design and fabrication alongside machine processes. "Standalone" performance in the sense of a diagnostic algorithm is not relevant here. The nonclinical testing for the components (TiBase and inCoris ZI meso) and software functionality demonstrate their individual performance characteristics.

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

• For Nonclinical Tests: The "ground truth" for the material and mechanical tests would be defined by the relevant ISO standards (e.g., ISO 5832-3:1996 for TiBase, ISO 13356:1997 for inCoris ZI meso blocks) and engineering specifications for fatigue analysis and dimensional accuracy. The software validation followed IEC 62304:2006 for medical device software.

8. The sample size for the training set

• Not applicable. This document describes a new device for which manufacturing and material specifications are compared to predicate devices and standards, not an AI/ML model that requires a training set. The "software database of titanium bases has been extended," which implies data was added, but not in the context of "training data" for a machine learning model.

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

• Not applicable. No training set for a machine learning model is mentioned.

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