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

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

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

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

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

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

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

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

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

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

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

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

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

• Not applicable for a non-clinical device submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted diagnostic device.

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The 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 Universal Base Conical Connection is a premanufactured prosthetic component directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The Universal Base Conical Connection consists 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 Conical Connection is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing conical connections.

The Universal Base Conical Connection 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 Conical Connection 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 Conical Connection is made of titanium vanadium alloy.

The provided text describes the Universal Base Conical Connection (CC) dental implant abutment and its equivalence to a predicate device, Nobel Biocare Universal Base Abutment (K180899). The text focuses on establishing substantial equivalence through mechanical, biocompatibility, software, and sterilization testing, rather than an AI-driven diagnostic device requiring extensive clinical studies with ground truth.

Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness, and training set details, are not applicable to this document. The document describes a traditional medical device (dental implant abutment) and its performance through engineering and manufacturing validation rather than a diagnostic algorithm.

Here's a summary of the information that is applicable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests indirectly through compliance with standards. Explicit numerical acceptance criteria are not detailed in a separate table, but compliance with ISO standards and other tests serves as the acceptance criteria.

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

• Sample Size: Not explicitly stated for each test, but standard test sizes as mandated by the referenced ISO standards would have been used. For example, ISO 14801 for dynamic fatigue testing of dental implants typically involves a specific number of samples (e.g., typically 5-10 samples per test group in some variations).
• Data Provenance: The tests are described as performance testing submitted in this 510(K) to support substantial equivalence, indicating they are internal validation studies performed by or for Nobel Biocare AG. No specific country of origin for the data or whether it was retrospective/prospective is mentioned, but typical medical device testing is prospective and conducted at qualified labs.

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 a component of a dental implant system, and its performance evaluation relies on engineering tests and compliance with recognized standards, not on expert interpretation of diagnostic images or clinical outcomes for establishing ground truth in the context of an AI algorithm.

4. Adjudication method for the test set

Not applicable for the reasons stated above.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) and is not applicable to a dental implant abutment.

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

Not applicable. This device is a physical medical component, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• Engineering measurements and material properties for mechanical strength and structural integrity.
• Chemical and biological assays for biocompatibility.
• Software validation logs and functional testing for software components.
• Sterilization cycle validation for sterile claim (or user sterilization instructions).
• Adherence to specified design parameters (e.g., angles, wall thickness).

8. The sample size for the training set

Not applicable. This device is not an AI algorithm.

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

Not applicable. This device is not an AI algorithm.

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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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