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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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