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The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For AT EV 3.0 S, AT TX 3.0 S, BH 3.0 S, and SB L 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 comprises three parts:

• Abutment Block material (CEREC Cercon 4D Abutment Block)
• Titanium Base (TiBase)
• CAD/CAM system

The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The proposed Dentsply Sirona Titanium Bases system are connected to Dentsply Sirona or third-party dental implants to facilitate the prosthetic dental restoration of edentulous areas of the oral anatomy. The proposed TiBase components are assembled (through extraoral cement bonding) with the patient specific CEREC Cercon 4D Abutment Block (K234018), to form the complete, two-piece CAD/CAM Titanium Base system abutments. The bottom half of the abutment is the TiBase component, which interfaces with the implant system-specific geometry, while the top half of the abutment is the abutment block material that is milled to form either an abutment crown or a meso-structure (the latter is subsequently finished with a crown). The TiBase component therefore serves as the "platform" on which the customized milled abutment crown or the meso-structure is bonded to, forming the complete CAD/CAM Titanium Base system abutment. The completed CAD/CAM Titanium Base system abutment is attached to the dental implant with an abutment screw.

The TiBase system is part of a workflow that includes CAD/CAM software cleared in predicate device, K193408, CAD/CAM system with CEREC Chairside Software, and reference device, K200191, CAD/CAM System with inLab Software, and the abutment crown and meso-structure material cleared in reference device, K234018.

The TiBase components are made of the same material as the predicate device (K193408) TiBases, which is titanium alloy Ti6Al4V, complying with ASTM F136-13. While the lower part connects to the implant system, the upper part consists of a tapered, cylindrical center post which is designed to receive the abutment crown or meso-structure to complete the finished CAD/CAM abutment.

The TiBase components come in small and large sizes depending on the diameter size of the connecting implant. A notch feature on the cylindrical part of the upper portion (i.e. rotational reference and lock) ensures that there is only one position to mount either a scanbody or the abutment crown/meso-structure.

The TiBase component center post includes a through-channel through which a corresponding abutment screw is inserted to allow retention of the finished abutment to the implant. The abutment screw, made of the same Titanium material, when assembled with the proposed TiBase component, is located in the internal geometry of the titanium base and does not seat in the finalized abutment crown/meso-structure.

The minimum/maximum design specification limits are as follows:

• Maximum angulation for the Zirconia top-half material: 20˚
• Minimum wall thickness of the Zirconia top-half material: 0.5 mm
• Gingival heights of the TiBase component: 1, 2, 3 mm
• TiBase component post height (i.e., length above the gingival height): ≥ 4 mm

This document is a 510(k) clearance letter for the Dentsply Sirona Titanium Bases system, which specifies its indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. It does not describe the specific acceptance criteria and detailed study results that prove the device meets those criteria in a format applicable to AI/ML software performance studies.

The document details the technical aspects of the dental implant components and their mechanical testing for safety and performance (e.g., fatigue testing), biocompatibility, reprocessing validation, and MR compatibility. However, it does not involve the types of performance metrics, test set characteristics, or ground truth establishment typically associated with AI/ML device evaluations.

Therefore, for aspects related to AI/ML device performance (like accuracy metrics, expert review, MRMC studies, standalone performance), the answer is "Not applicable" or "Not provided" as this is a traditional medical device clearance, not an AI/ML software clearance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests that the device was subjected to and that it "met acceptance criteria" or "showed similar results" to reference devices. However, the specific quantitative acceptance criteria (e.g., "fatigue strength must be > X N") and the exact reported quantitative performance values achieved by the Dentsply Sirona Titanium Bases system are not explicitly stated in this clearance letter. The letter generally refers to compliance with standards.

For example, for fatigue testing, it states: "The TiBases systems were subjected to fatigue testing per the following requirements and showed similar results when compared to the reference devices (K213961, K241485)" and refers to ISO 14801:2016 and FDA Special Controls Guidance. It does not provide the numerical results or the specific acceptance mechanical load values. The same applies to MR testing, reprocessing, and biocompatibility.

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

• Sample Size: Not explicitly stated in terms of the number of unique devices/tests in the provided text. The fatigue testing mentions "the proposed device performs as well as the reference devices (K213961, K241485)," implying a comparison and potentially new tests for the specific new TiBases. However, specific counts are not given.
• Data Provenance: The studies are non-clinical (laboratory tests) rather than human patient data. Therefore, "country of origin" and "retrospective/prospective" are not applicable in the context of patient data. The tests were performed to demonstrate compliance with international standards (ISO, ASTM) and FDA guidance.

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

• Not Applicable (N/A). This is a mechanical/material device clearance, not an AI/ML software evaluation based on expert-labeled data. The "ground truth" for these tests refers to the objective results conforming to engineering and material science standards (e.g., a device either fractures at a certain load or it doesn't, a material is biocompatible or not).

4. Adjudication method for the test set

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is not an AI/ML software device that involves human interpretation of medical images.

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

• Not Applicable (N/A). This is a physical device, not an algorithm. The "software system verification" refers to confirming that the CAD/CAM software correctly integrates the design parameters for the physical components, not an AI algorithm's standalone diagnostic performance.

7. The type of ground truth used

• For mechanical (fatigue) testing: Compliance with ISO 14801:2016 and FDA guidance, meaning the physical behavior of the device under specified loads.
• For MR testing: Compliance with ASTM standards, meaning objective measurements of displacement, torque, and image artifacts.
• For software verification: Conformation that design parameters are correctly implemented in CAD/CAM software.
• For reprocessing and biocompatibility: Compliance with ISO standards and FDA guidance, meaning objective evaluations of sterility and biological response.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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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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The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.

The TIB Abutment base is a standard premanufactured titanium alloy abutment for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case by case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The TIB Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K 130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
• Abutment design software: 3Shape Abutment Designer Software (K151455)
• Milling machine: Roland DWX51D Milling Machine

The provided text describes the TIB Abutment System and its performance data to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a study with specific performance metrics.

Therefore, I cannot populate the table or answer questions 2 through 7 directly from the provided text as the document does not present acceptance criteria in a quantitative format, nor does it detail a standalone study with performance metrics for the TIB Abutment System against such criteria. Instead, it relies on comparative equivalence with already cleared devices and various non-clinical tests.

However, I can extract information related to the performance data and ground truth establishment that were conducted as part of the substantial equivalence demonstration.

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

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" for the TIB Abutment System in a format that would fit a table like the one requested. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons. The performance data listed are primarily compliance tests against recognized standards rather than specific device performance metrics against predefined thresholds.

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

The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests mentioned. It only lists the types of tests performed.

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. The document refers to non-clinical tests and compliance with standards, not expert-adjudicated ground truth.

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

Not applicable. The document refers to non-clinical tests and compliance with standards, not expert 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 abutment system, not an AI-assisted diagnostic device, and no MRMC study or AI-related effectiveness is mentioned.

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

The document describes non-clinical testing of the device components and workflow, which can be considered a form of standalone evaluation for the device itself. The types of standalone tests performed include:

• Biocompatibility testing per ISO 10993-1 and ISO 10993-5.
• Validated sterilization instructions per ISO 17665-2.
• Software validation testing per FDA Guidance.
• Scanning and milling validation.
• Static and dynamic compression-bending to ISO 14801.
• Mechanical ISO 14801 Fatigue Testing for implant platforms.

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

The "ground truth" in this context is established by adherence to recognized international standards and FDA guidance documents for medical device testing. For example:

• Biocompatibility: ISO 10993-1 and ISO 10993-5 standards.
• Sterilization: ISO 17665-2.
• Software Validation: FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.
• Mechanical Testing: ISO 14801.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dental abutment system) and its non-clinical testing for substantial equivalence, not a machine learning model 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 a machine learning model mentioned.

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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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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 Ti-base abutment are to be made from inCoris ZI, 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 and 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 zirconia-titanium abutment consisting of a zirconium coping/mesostructure and a titanium base.

The top-half custom zirconia coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide 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. The InCoris Zi mesostructure is to be cemented to the subject MIS Ti-base abutments using PANAVIA F 2.0 dental cement in order to complete the two-piece, CAD/CAM abutment.

lt 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 conical 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.

Here's a breakdown of the requested information based on the provided FDA 510(k) document for the MIS Ti-base Abutment.

Important Note: This document describes a dental abutment, not an AI/ML device. Therefore, many of the requested fields regarding AI/ML-specific study aspects (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of medical device submission. The FDA 510(k) process for a device like this focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing.

Device Name: MIS Ti-base Abutment
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI/ML medical devices like this, "acceptance criteria" are tied to demonstrating substantial equivalence to a predicate device, often through mechanical and material testing against established standards. The performance is assessed against these standards and comparative data from the predicate.

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

• Sample Size for Test Set:
  • For Fatigue Testing (ISO 14801:2016), samples were tested. While a specific number isn't explicitly stated on the provided pages, ISO 14801 typically requires a sufficient number of samples (often 5-10 per test group) to achieve statistically meaningful results for fatigue curves. The document refers to testing "worst case abutments" from both narrow and standard platforms.
  • For Sterilization Testing, an unspecified number of representative samples would have been used for validation.
  • For Software Verification & Validation, the "test set" would be various design scenarios and inputs used to confirm software functionality and adherence to design constraints. The specific "sample size" of test cases is not quantified here.
• Data Provenance: The studies were non-clinical performance tests conducted by MIS Implants Technologies (manufacturer). The location of testing is not specified, but the manufacturer (Dentsply Sirona / MIS Implants Technologies Ltd.) is located in the USA (York, Pennsylvania) and Israel, respectively. These are prospective tests performed specifically for this 510(k) submission.

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

• N/A (Not Applicable for this device type). Ground truth based on expert consensus is typically relevant for AI/ML diagnostic or prognostic devices. For a dental implant abutment, "ground truth" is established by adherence to engineering standards, material specifications, and mechanical performance limits. The "experts" involved would be engineers and quality control personnel responsible for developing and conducting the tests, interpreting standard requirements, and designing robust products. Their qualifications would be in relevant engineering, materials science, and quality assurance fields.

4. Adjudication Method for the Test Set

• N/A (Not Applicable for this device type). Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for AI/ML devices, where human readers (often physicians) independently evaluate medical images or data, and a tie-breaking or consensus process is needed. For mechanical and software performance testing, adjudication is based on objective measurements and established pass/fail criteria from international standards.

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. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance was not conducted and is not relevant.

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

• N/A. This is not an AI/ML algorithm. Its "performance" is mechanical and procedural, not algorithmic. The software component (CEREC SW) is for design and manufacturing, not for automatic diagnosis or interpretation.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is established by:
  • Engineering Standards: Adherence to established international voluntary consensus standards (e.g., ISO 14801:2016 for fatigue, ANSI/AAMI/ISO 17665 for sterilization).
  • Material Specifications: Compliance with material standards (e.g., ASTM F136 for TI-6Al-4V ELI).
  • Validated Design & Manufacturing Parameters: Verification that the CAD/CAM software maintains design limitations and that the manufacturing process yields correct physical properties.
  • Predicate Device Performance: Comparative performance data against the legally marketed predicate devices serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device, so there is no "training set." The development process relies on engineering design, material science, and established manufacturing practices, not machine learning.

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

• N/A. As there is no training set for an AI/ML model, this question is not applicable.

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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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DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.

The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.

1. Hybrid Link abutment: Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm. Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment.

2. Patient-Specific Abutment: Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific Abutment are 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex). Patient-specific abutments are supplied with an abutment screw previous cleared device as K122519 and K161987 and provided non-sterile.

The document provided is a 510(k) Premarket Notification from the FDA for a dental implant abutment. It does not describe a study involving an AI/ML device, nor does it provide acceptance criteria or performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices through material properties, design specifications, and non-clinical testing for dental implant abutments.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance from this document. The sections you asked for, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, are not applicable to the content of this 510(k) summary for a physical medical device.

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The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The On1 Universal Abutment is a dental implant abutment which attaches to the On1 Base of the On1 Concept (K161655) and is intended to be used with the current Nobel Biocare dental implants that have the existing internal conical connection.

The On1 Universal Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for either an in-laboratory CAD/CAM system made mesostructure or abutment crown. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.

The On1 Universal Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for the internal conical connection. The On1 Universal Abutment is made of titanium vanadium alloy.

The document does not detail specific acceptance criteria or a dedicated study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with defined endpoints. Instead, it describes a 510(k) summary for substantial equivalence, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "study" in this context is a series of non-clinical performance tests designed to show that the On1 Universal Abutment performs comparably to its predicate and reference devices, and that any differences do not raise new questions of safety or effectiveness.

Here's the breakdown of the information requested, based on the provided text:

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

The document does not explicitly state "acceptance criteria" for performance in a table format. However, it does list "Restorative design specifications" which act as internal design criteria, and various performance tests that the device successfully met. The key "acceptance criterion" implied throughout the document is "substantial equivalence" to the predicate devices.

• Compliance with minimum required fatigue properties per ISO 14801.
• Restorative design specifications:
  • Angle from axis of the implant: 20° Max
  • Wall Thickness Circular: 0.8mm min.
  • Wall Thickness Margin: 0.275mm min.
  • Post Height: 5.2mm min.
  • Maximum Length, width and Height: EM-14 blank 12x14x18mm, EM-10 blank 8x10x15mm | Mechanical Performance:
• "Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the On1 Universal Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed On1 Universal Abutments were equivalent to the predicate devices."
• Device design adheres to the listed restorative design specifications. |
  | Biocompatibility:
• Compliance with ISO 10993-1, ISO 10993-5 (Cytotoxicity), CEN EN ISO 10993-12, and CEN EN ISO 10993-18 (GC-MS analysis for organic leachables/extractables). | Biocompatibility:
• "Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. GC-MS analysis was performed... Results indicate that the devices met biocompatibility requirements for its intended use." |
  | Software Verification and Validation:
• Restrictions prevent design of mesostructure component outside of design limitations.
• Established design limitations and specifications are locked and cannot be modified within the abutment design library. | Software Verification and Validation:
• "Validation was completed on the On1 Universal Abutment with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORiTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment DesignerTM Software (K151455). ...testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations... In addition, 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." |
  | Sterilization Validation:
• Compliance with AAMI-TIR30, ISO 17665-1, and ISO 17665-2 for steam sterilization. | Sterilization Validation:
• "Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2." |
  | Device Packaging:
• No new worst-case in terms of device packaging and shelf life compared to predicate. | Device Packaging:
• "The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required." |

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: The document does not specify the exact sample sizes for the mechanical, biocompatibility, software, or sterilization testing. It refers to "worst case dynamic fatigue testing" and "the finished devices" for biocompatibility without providing numbers.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission from Nobel Biocare AB (Sweden) and Nobel Biocare USA LLC (USA), it's likely the testing was conducted in facilities accustomed to international and US regulatory standards, but specific locations are not mentioned. The nature of the tests (mechanical, biocompatibility, software, sterilization) suggests controlled laboratory experiments, not patient data.

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)

This section is not applicable as the document describes non-clinical performance testing for a dental implant abutment, not a diagnostic or screening device that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests would be the established international standards (e.g., ISO 14801, ISO 10993 series).

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

This is not applicable for the type of non-clinical performance testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving reader interpretation (e.g., radiologists, pathologists) where discrepancies need to be resolved to establish ground truth for a test set. The tests here are objective engineering and material science evaluations.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study assesses human performance, often in diagnostic tasks, and is not relevant for a dental implant abutment. The device is a physical component, not an AI-powered diagnostic tool.

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 dental implant abutment, not an algorithm or AI system. Software verification and validation were performed for the accompanying design software, but this is distinct from "standalone algorithm performance" in the context of AI.

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

The "ground truth" for the performance testing described are established international standards and specifications (e.g., ISO 14801 for dynamic fatigue, ISO 10993 series for biocompatibility, AAMI-TIR30, ISO 17665-1/2 for sterilization). For software, the ground truth is the predefined design limitations and specifications that the software must enforce and protect.

8. The sample size for the training set

This is not applicable. The device is a physical component, not an AI model that requires a training set. The descriptions of "design workflow" and "manufacturing workflow" refer to the process by which the abutment is designed and fabricated, not machine learning model training.

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

This is not applicable as there is no training set for an AI model.

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The Universal Base Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The Universal Base Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The Universal Base Abutment is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing external hex style connections. The Universal Base Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process. The Universal Base Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Abutment is made of titanium vanadium alloy.

This document describes the Universal Base Abutment, a dental implant abutment. The information provided outlines the device's technical specifications, comparisons with predicate devices, and performance data from various tests. However, it does not include specific acceptance criteria with numerical targets for clinical performance, nor does it detail a study proving the device meets those specific acceptance criteria in the context of clinical accuracy or diagnostic efficacy.

Therefore, the following information is extracted based on the provided text, and points that cannot be addressed due to the nature of the document (a 510(k) summary for a dental abutment, not an AI/diagnostic device) are explicitly stated as "Not Applicable".

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical device (dental abutment) and not an AI or diagnostic device, the acceptance criteria are based on mechanical and biological safety and performance, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC. The "performance" reported is related to adherence to established standards for dental implants and abutments.

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 for Test Set: Not explicitly stated in terms of a "test set" for clinical performance. The mechanical testing (dynamic fatigue) would have used a sample size determined by ISO 14801 standards (e.g., typically N=10 or more per group for fatigue testing), but this is not a diagnostic test set.
• Data Provenance: Not applicable in the context of clinical patient data for a diagnostic device. The testing described (mechanical, biocompatibility, software V&V) is laboratory-based.

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 device is a dental abutment, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis. Ground truth in this context relates to engineering standards and material science.

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

• Not Applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy to reconcile conflicting expert opinions. This document describes non-clinical, laboratory-based performance testing against ISO standards.

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 abutment, 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 dental abutment. While there is "Software Verification and Validation" for the design library to ensure it prevents designs outside limitations, this is about the design tool's functionality, not about an AI algorithm's standalone diagnostic performance.

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

• The "ground truth" for this device's evaluation is based on established international standards for medical device performance (e.g., ISO 14801 for dynamic fatigue, ISO 10993 for biocompatibility) and engineering specifications for the CAD/CAM workflow.

8. The sample size for the training set

• Not Applicable. This device submission does not describe an AI algorithm that requires a training set. The software mentioned (3Shape Abutment Designer Software) is a CAD/CAM design tool, not a machine learning model.

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

• Not Applicable. As no AI training set is described, this question is not relevant.

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