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Straumann® RidgeFit Implants ∅ 2.4 mm are indicated for oral endosteal implantation in the fully edentulous mandible and/or maxilla for the stabilization of removable dentures. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved on all implants.

• Mandibular restorations require at least 4 Straumann® RidgeFit Implants ∅ 2.4 mm.
• Maxillary restorations require at least 6 Straumann® RidgeFit Implants ∅ 2.4 mm.

The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid® (Titanium-Zirconium alloy, TiZ) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion, which is coated in Titanium Nitride (TiN) coating, resulting in a one-piece implant system acting as a retention feature for dentures. The Straumann® RidgeFit Implants have an external diameter of 2.4 mm and are available in implant lengths 10 mm, 12 mm and 14 mm with a gingival height of 2.8 mm and implant lengths 10 mm and 12 mm for gingival heights 3.8 mm and 4.8 mm. The Straumann® RidgeFit Implants ∅ 2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully edentulous patients. Conventional loading is recommended if primary stability cannot be achieved immediately on all implants.

The provided FDA 510(k) clearance letter and summary for the Straumann® RidgeFit Implants contains information regarding the device's technical specifications and non-clinical testing. However, it does not include any information about acceptance criteria or a study that uses a test set with ground truth established by experts to prove the device meets these criteria.

The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical engineering tests (fatigue, insertion torque, biocompatibility, sterilization, packaging stability, MRI compatibility). These are performance tests on the device itself, not evaluations based on human-in-the-loop or standalone AI performance using a study with a test set and expert-established ground truth.

Therefore, I cannot provide the requested information for the following points as they are not present in the given text:

• A table of acceptance criteria and the reported device performance: The document implicitly states that passing the non-clinical tests demonstrates "substantial equivalence," but does not define explicit acceptance criteria or performance metrics directly from a comparative study with a test set and ground truth.
• Sample sized used for the test set and the data provenance: No such test set or study is described within the provided text.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or expert ground truth establishment is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. The clearance is for an endosseous dental implant, which is a physical device, not an AI software intended for interpretation or diagnostic assistance that would typically undergo such studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does provide regarding testing:

The device's performance is proven through a summary of non-clinical testing, which includes:

1. Dynamic fatigue testing: Conducted according to FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments) and ISO 14801 ("Dentistry — Implants — Dynamic loading test for endosseous dental implants"). This testing demonstrated the subject devices are equivalent to primary predicate and reference devices.
2. Insertion torque and Torque-to-failure test: Conducted and demonstrated substantial equivalence to the primary predicate device.
3. Biocompatibility evaluation: Referenced K211052 and K191895 for evaluation in accordance with ISO-10993-1:2018 and FDA guidance.
4. Sterilization validation: Referenced K211052 and K191895 for validation in accordance with ISO 11137-1:2006 (VDmax25 method).
5. Packaging stability and shelf-life study: Referenced K211052 and K191895 for studies in accordance with ISO 11607-1:2019, ASTM F1886, ASTM F1929, and ASTM F88.
6. MRI simulations: Conducted to demonstrate that the devices are MR Conditional.

These tests are primarily physical and chemical performance assessments of the implant materials and design, aimed at establishing safety and effectiveness, and equivalence to existing cleared devices, not at evaluating an AI's diagnostic performance against human experts.

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The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

The Straumann Custom Abutments (previously named Straumann CARES Abutments) are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. The Custom Abutments are patient-matched abutments; the customer scans the intraoral situation and designs the shape using a Straumann-approved CAD/CAM software (such as Straumann CARES Visual). The design data is then transferred to Straumann where the fabrication of the custom abutment is carried out at a Straumann validated milling center (FEI: 3024185724 or FEI: 3011221537). The existing Custom Abutments feature a straight screw channel for the basal screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments with an angled screw channel to the Straumann Custom Abutment Portfolio. The subject Custom Abutments can be designed and manufactured with an angled screw channel (as opposed to straight), so that the screwexit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angled, the screwdriver maximum angle is 20°.

The Custom Abutments are designed for connection to implants of the Straumann Dental Implant System. The Custom Abutments have an implant-specific connection interface for the respective compatible implant. The Custom Abutments with the SynOcta geometry (RN or WN) are designed for connection to the Straumann Tissue Level (TL) implants. Those with the CrossFit geometry (NC or RC) are designed for connection to the Bone Level (BL) and Bone Level Tapered (BLT) implants. The Custom Abutments with the TorcFit geometry, are designed for connection to the Straumann Bone Level BLX and BLC (RB/WB or WB) or Tissue Level TLX and TLC (NT, RT, WT) implants. The basal screws feature threads to secure the abutment with the implant inner geometry. The basal screws also contain the connection geometry to mate with the AS screwdrivers for installation into the implant.

The provided text is a 510(k) Summary for "Custom Abutments" and details the substantial equivalence of the device to legally marketed predicate devices. It does not contain information on an AI/ML-driven device or study results proving a device meets acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, FROC, etc.).

The document describes a dental implant abutment designed for customized patient use, with a key modification being the addition of an angled screw channel. The non-clinical testing sections focus on mechanical fatigue testing, digital workflow validation, sterilization, MRI compatibility, and biocompatibility, as is typical for a medical device of this type.

Therefore, I cannot fulfill your request for information on acceptance criteria and study proving device meets acceptance criteria for an AI/ML device, as the provided text pertains to a traditional medical device (dental abutments) and does not mention any AI/ML component.

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Patient-specific abutment restorations, milled from Pre-milled Abutment Blanks (PMABs), are indicated for single tooth replacement and multiple tooth restorations. They are directly connected to various endosseous dental implant systems using a basal screw. Patient-specific abutment restorations milled from Pre-milled Abutment Blanks are to be digitally designed and milled using the Straumann InLab Validated Workflow. The Straumann InLab Validated Workflow is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners. CAD software, CAM software, pre-milled abutment blanks, milling machines and associated tooling and accessories.

The Straumann InLab Validated Workflow is similar to the primary predicate K171649. It employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The 3Shape CAD software then allows the design of the desired restorations.

The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. When choosing the Straumann Validated workflow, the user will only see the available and cleared components which were tested and demonstrated as part of the validated workflow. The milling command file is encrypted prior to transfer to the Roland DWX-42W Plus milling System; this encryption ensures that files generated using other CAD or CAM software cannot be used with the Straumann InLab Validated Workflow. The user will then load the milling command file into the Roland DWX-42W Plus milling System where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.

This premarket notification includes restorations (one-piece metal patient-specific abutment restorations) manufactured from various Pre-milled Abutment Blanks (PMABs) from the Straumann Group companies : Institut Straumann AG and Neodent PMABs. The digital workflow using the Straumann InLab Validated Workflow includes the use of the following products: Dental Scan of the patient's situation, CAD Software, CAM Module, Milling System, Abutment Milling Blanks.

The provided text is a 510(k) Summary for the Straumann InLab Validated Workflow, a device for designing and manufacturing patient-specific dental abutments from pre-milled abutment blanks (PMABs). The document describes the device, its intended use, technological characteristics, and performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in a consolidated format as typically seen in a clinical study report. However, it mentions key performance areas and states that requirements were met.

Acceptance Criteria (Implicit from tests performed):

• Sterilization Validation: Meet ISO 17665-1 and FDA guidance for reprocessing medical devices.
• Biocompatibility: In line with ISO 10993-1 and FDA guidance for biological evaluation.
• Electromagnetic Compatibility (EMC): Considered MR Conditional.
• Milling Accuracy: Dimensions of milled restoration are the same as the intended CAD design, met within tool's expected lifetime.
• Simulated Use Validation: Correct implementation of PMABs, design constraints, and workflow restrictions in software and libraries.
• Implant-Abutment Connection Protection: No damage to the connection geometry during milling.
• Dynamic Fatigue: Performance consistent with FDA guidance for dental implants/abutments.

Reported Device Performance:

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

The document does not specify the exact sample sizes used for the test sets in the performance studies (e.g., dynamic fatigue, milling accuracy, simulated use validation). It refers to these as "Performance Testing - Bench."

Data Provenance: The studies are described as "nonclinical tests" and "bench" testing, suggesting they were conducted in a laboratory or simulated environment, rather than involving patient data. The document does not specify country of origin for the data (beyond the applicant being Institut Straumann AG in Switzerland and JJGC Indústria e Comércio de Materiais Dentários AS in Brazil, with contact in Andover, MA, USA). The studies appear to be prospective, designed specifically for this submission.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation methods described (e.g., milling accuracy, simulated use) imply technical verification against design specifications and functional requirements rather than expert consensus on diagnostic or clinical outcomes.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as there is no indication of multiple reviewers or subjective assessments requiring adjudication in the described bench tests.

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

No MRMC comparative effectiveness study is mentioned. The device is a workflow for manufacturing dental restorations, not an AI diagnostic or assistive tool for human readers in the traditional sense of comparing human performance with and without AI assistance for interpretation.

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

The milling accuracy test ("black-box validation confirming that the dimensions of the milled restoration are the same as the intended CAD design") and the simulated use validation implicitly test the algorithm and workflow in a standalone manner, separate from a human operator's interpretative judgment. The "Straumann InLab Validated Workflow" itself is largely an automated process once the design is finalized. It is designed to ensure that the digital design translates accurately into a physical product.

7. Type of Ground Truth Used

The ground truth used for these performance tests appears to be:

• Design Intent/Specifications: For milling accuracy, the ground truth is the CAD design itself. For simulated use, the ground truth refers to the correct implementation of design constraints and workflow restrictions within the software and libraries.
• Industry Standards and Regulatory Guidance: For sterilization, biocompatibility, and dynamic fatigue, the ground truth is defined by recognized international standards (ISO) and FDA guidance documents.
• Functional Requirements: For implant-abutment connection protection, the ground truth is the prevention of damage to the connection geometry.

8. Sample Size for the Training Set

The document does not describe the use of machine learning or AI models in a way that would involve a distinct "training set" in the context of typical software or diagnostic AI submissions. The workflow involves CAD/CAM software where parameters and constraints are defined by engineering and design principles rather than learned from a large training dataset.

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

As no specific training set for a machine learning model is described, there is no information on how its ground truth would have been established. The workflow relies on validated engineering designs, material properties, and manufacturing processes.

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The Straumann CARES Visual/Nova Implant-borne CAD software are indicated for the design of two-piece or one-piece abutment components for single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners and CAD software. The system is used to design two-piece abutment CAD/CAM milled copings, crown and bridge restorations to be cemented onto Ti-bases, customized one-piece abutments and bridges/bars to be affixed to the endosseous dental implants using a basal screw. The use of the software requires the user to have the necessary training and domain knowledge in the practice of prosthetic design, as well as training in the use of the software.

Straumann CARES Visual/Nova is a dental CAD software to create implant-borne restorations. The software employs optical impression files that represent the topographical characteristics of the patient's intraoral situation. The Straumann CARES Visual/Nova software then allows the desired restorations. All implant-borne restorations available in Straumann CARES Visual/Nova software require FDA review and 510(k) clearance. Design specifications ("design envelope"), selectable materials, mouth positions need to be described in these 510(k) submissions. Each restorative solution is defined in a secured design library that provides the CAD software with the design specifications and restrictions for instance, minimum wall thickness, maximum angulation, cementable abutment post height etc. Standard connecting geometries e.g., abutment to implant interface are also defined in the library which cannot be edited by a user. Any dental implantborne restoration can only be created within the 510(k)-cleared design envelope.

The output of the CAD software is a three-dimensional geometry file which is linked to meta data like material and patient identifier.

All designed implant-borne restorations are intended to be:

• sent to Straumann for manufacturing by a validated milling center, or .
• milled on a validated Straumann C series or M series milling machine (only . with the CARES Visual software, K171649 and K203456)
• 3D printed as a temporary crown, or temporary bridge (up to 180 days) using P pro . Crown & Bridge material on a validated Straumann P series printer (only with the CARES Visual software, K203750)

Straumann CARES Visual/Nova has no patient contact since it is software.

The provided text is a 510(k) summary for the Straumann CARES Visual and Nova Dental CAD software. This document outlines the device's indications for use, its technological characteristics, and a comparison to predicate devices, but lacks detailed performance study information with numerical acceptance criteria and measured performance.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Performance Testing - Bench" and "Software verification and validation testing," indicating that tests were performed to demonstrate that the software adheres to design specifications and restrictions. However, it does not provide specific numerical acceptance criteria (e.g., accuracy percentages, dimensional tolerances) or their corresponding numerical performance results.

Instead, the acceptance criteria are implicitly described as:

• The software effectively controls design specifications and material selections for compatible abutment design libraries that undergo separate 510(k) clearance.
• Restrictions prevent the design of patient-matched components outside of allowable design limitations.
• Design limitations and specifications of compatible implant-abutment design libraries are locked and cannot be modified by the end user.

The reported performance is a general statement that these tests were "provided to demonstrate" and "conducted to demonstrate" these aspects. No quantitative measurements are included.

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

The text does not specify the sample size used for the test set or the provenance of any data (e.g., country of origin, retrospective/prospective). It only refers to "representative screenshots under user verification testing," which suggests qualitative evaluation rather than quantitative statistical analysis on a defined dataset.

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

The document does not mention the use of experts to establish ground truth for a test set. The validation appears to be centered on the software's functionality and adherence to predefined design rules rather than a comparison to expert-derived ground truth on clinical cases.

4. Adjudication Method for the Test Set

As there's no mention of experts establishing ground truth or evaluating cases, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned. The device is CAD software for designing dental prosthetics, which is different from an AI-assisted diagnostic tool where human reader performance would typically be assessed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing described is inherently standalone from a human-in-the-loop perspective, as it verifies the software's ability to enforce design rules and generate valid geometry files. The software's output (geometry file) is then used for manufacturing. The device inherently functions "without human-in-the-loop performance" in terms of its core design rule enforcement, although a human user still operates the software to create the design.

7. The Type of Ground Truth Used

The ground truth for this device appears to be primarily predefined design specifications and limitations based on engineering rules, material properties, and anatomical considerations for dental prosthetics. The software's internal logic and libraries incorporate these rules. It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or predictive AI.

8. The Sample Size for the Training Set

The document does not mention a training set for the software. This suggests that the software is likely rule-based CAD software rather than a machine learning or AI model that requires a training set of data. Its functionality is based on programmed algorithms and predefined libraries ("design envelope").

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

Since no training set is mentioned, this point is not applicable.

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The Strauman® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw.

The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implants (Tissue Level Monotype and Tissue Level two-piece design) are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. The Straumann® PURE Ceramic Implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched (ZLA® surface). The implants have a 1.8 mm high machined transmucosal neck. The Straumann® PURE Ceramic Implant has a two -piece design with internal connection based on features of the Straumann® Tissue Level Standard Plus and Straumann® Bone Level Implants. The Straumann® PURE Ceramic Implant Monotype features a monotype design where the ceramic abutment for final restoration is already built in.

This document, a 510(k) summary for the Straumann® PURE Ceramic Implants, does not contain information about an AI/ML device or a study proving its performance against acceptance criteria in the way a typical AI/ML medical device submission would.

The document describes a dental implant (a physical medical device) and its equivalence to previously cleared predicates. The nonclinical testing mentioned (dynamic fatigue, biological assessment, sterilization validation, packaging stability, MRI compatibility, surface features) are standard tests for physical implants to ensure their safety and effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from this document. The concepts of "test set," "ground truth experts," "adjudication," "MRMC study," "standalone performance," "training set," and "how ground truth for training set was established" are not applicable to the non-AI/ML device described in this 510(k) summary.

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Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.

They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCl). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.

The purpose of this premarket notification is to extend the BLC and TLC Implants portfolio by including new sizes of implants, more specifically:

BLC implants:

• L 16 mm for diameter Ø 6.5 mm, presented with WB (Wide Base) prosthetic platform.
  TLC implants:
• L 14 mm and L 16 mm for diameter Ø 5.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)
• L 8 mm and L 10 mm for diameter Ø 6.5 mm and implant neck Standard (2.8 mm height)
• L 12 mm to L 16 mm for diameter Ø 6.5 mm, with both implant neck options Standard (2.8 mm height)

and presented with WT (Wide TorcFit) prosthetic platform.

The submission also introduces a new sterilization method using X-ray irradiation which was validated on worst-case test articles representative of the BLC and TLC implant systems.

This is a 510(k) summary for a medical device that is cleared based on substantial equivalence to predicate devices, not on meeting specific performance acceptance criteria in the same way an AI/ML device might. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

Device Type: This document is for an Endosseous Dental Implant, not a software or AI/ML device. The acceptance criteria and performance study described are focused on hardware aspects (sterilization, biocompatibility, mechanical performance) rather than algorithmic performance.

Applicable Information from the document:

Since this is a dental implant and not an AI/ML device, concepts like "test set," "training set," "experts to establish ground truth," and "MRMC study" are not relevant in the context of the device's technical clearance. The document focuses on showing the new implants are substantially equivalent to previously cleared implants.

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

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

• Sterilization Validation: The document mentions "worst-case test articles representative of the BLC and TLC implant systems" for X-ray sterilization validation. It does not provide a specific sample size. The methods (VDmax25) are standard for radiation sterilization validation.
• Biocompatibility Testing: The document refers to "assessed devices" and "conducted tests" (e.g., at T0, T3, T5 for X-ray sterilization impact). Specific sample sizes are not provided, but the testing followed ISO 10993-1.
• Mechanical Testing (Insertion Torque): "Insertion tests were performed for the subject implants." No specific sample size is given.
• Data Provenance: The studies appear to be internal validation studies conducted by the manufacturer, not patient data from specific countries. They are prospective in the sense of being planned validation tests for the device changes.

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

• This concept is not applicable as the studies described are bench and lab validations against industry standards (ISO, FDA guidance), not expert-interpreted clinical data. The "ground truth" is defined by the technical specifications and performance against those standards.

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

• Not applicable for these types of technical validation studies. Adjudication methods are typically used in clinical trials or studies involving human interpretation of medical images or data.

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/ML device, nor does it involve human readers interpreting data assisted by the device.

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

• Not applicable. This is a physical medical device (dental implant).

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

• The "ground truth" in this context is defined by established international standards (e.g., ISO 11137 for sterilization, ISO 10993-1 for biocompatibility, FDA guidance for MR Conditional status) and the engineering specifications/performance achieved by the device. It's essentially performance against predefined engineering and safety standards.

8. The sample size for the training set

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

Conclusion based on the document:

The device is an extension of existing dental implants, and its clearance relies on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implied by the need to conform to generally recognized standards and to demonstrate that the new sizes and sterilization method do not introduce new safety or effectiveness concerns compared to the predicates. The studies performed are primarily bench testing and validation studies to confirm the physical and biological characteristics of the implants meet these standards.

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Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.

The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm.

The BLC implants are available with the following length options:

• L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm.
• L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm
• L 6 mm to L 16 mm for diameter Ø 5.5 mm
• L 6 mm to 14 mm for diameter Ø 6.5 mm.

The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform.

The TLC implants are available with the following length options:

• L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm,
• L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm
• L 6 mm to L 12 mm for diameter Ø 5.5 mm
• L 6 mm to 10 mm for diameter Ø 6.5 mm.

The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. The document is an FDA 510(k) summary for Straumann® BLC and TLC Implants, which are endosseous dental implants, not an AI/ML device.

Therefore, I cannot provide the requested information.

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Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Straumann® BLX Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Straumann® TLX Dental Implants, SLActive®
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. Unless stated in specific indications, they can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Specific indications for use
Straumann® Roxolid® Bone Level Tapered Implant ø 2.9 mm
The Straumann® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Roxolid® Standard Plus 4 mm Short Implants
Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.

Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for:
Fixed denture prosthesis/splinted units (one implant per unit).
Pontic cases in combination with at least one longer implant.
Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants.

Titanium Ø 3.3 mm implants
ø3.3 mm S and SP RN implants are to be used only for the following indications:
Partially dentate jaws with implant-borne, fixed constructions: combine with a Ø4.1 mm implants and splint the superstructure.

The SLActive® Implants from the Straumann® Dental Implants System includes:
SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 NNC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø2.9 SC 10, 12 and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, 14. 16 and 18 mm
SLActive® and Roxolid®, BLX, Ø3.5 RB, 8, 10, 12, 14, 16, 18 mm
SLActive® and Roxolid®, BLX, Ø3.75 RB, Ø4.0 RB, Ø4.5 RB and Ø5.0 RB, 6, 8, 10, 12, 14, 16. 18 mm
SLActive® and Roxolid®, BLX, Ø5.5 WB and Ø6.5 WB, 6, 8, 10, 12, 14 and 16 mm
SLActive® and Roxolid®, Standard, TLX, Ø3.75 NT, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus Short, Ø4.1 RN and Ø4.8 RN and WN, 4 mm 4 mm Short Implants

The device being discussed is "Straumann® SLActive® labeling changes" (K223083). This 510(k) pertains to labeling changes for existing Straumann® SLActive® dental implants and does not introduce new implants or modify existing implant designs. The primary predicate device is K171784 – Straumann Dental Implant System, with several other Straumann® implant systems listed as reference devices.

The acceptance criteria and supporting study are primarily focused on substantiating the updated labeling, particularly regarding the use of SLActive implants in smokers and general wording clarifications.

1. Table of Acceptance Criteria and Reported Device Performance

• All indications continue to allow for implant placement in the jaw, providing support for single-tooth or multiple-tooth restorations, and allowing for immediate loading when good primary stability is achieved.
• Information regarding prosthetic restorations was not excluded but relocated to the device description for better understanding.
• The requirement for "4 or more implants for fully edentulous patients" was removed from indications for use as it is considered "common knowledge."
• New specific Indications for Use for Ø 3.3 mm implants provide more details.
• The "Precaution" section of the Instructions for Use now addresses the use of narrow implants in the molar region.
• For specific implant types (e.g., BLX implants), the single-tooth restoration was considered the "worst case due to the higher masticatory load," indicating an understanding of potential stress. |
  | For "Smokers' Claim" (Outcomes of SLActive implants in smokers are encouraging):
  Supported by clinical evidence demonstrating that implant performance (e.g., failure rates, adverse events) is not significantly worse in smokers compared to non-smokers with SLActive implants.
  Demonstrated through systematic literature review or clinical studies. | A systematic literature search identified 5 publications.
• 251 SLActive implants were placed in 237 patients (age range 25-65 years old).
• Studies included titanium or titanium-zirconium alloy implants with SLActive surfaces, diameters 3.3-4.8 mm, and lengths 8-12 mm.
• Reported adverse events (failure to osseointegrate, peri-implantitis, spinning/mobility during surgery, late failure, bone loss, abutment loosening, paresthesia, acrylic/porcelain chipping) were not reported at a higher rate in smokers compared to non-smokers.
• Implant failure rates were not found to be significantly different in smoking compared to non-smoking patients with SLActive implants.
• References: Alsahhaf A (2019), Xiao W (2021), Chen Y (2017), Sener T (2010), Luongo G (2016). (Note: Sener and Luongo were cited in the text but not fully listed in the provided references section). |
  | Sterility:
  Sterilization process validated to SAL of 10^-6.
  Meets pyrogen limit specifications. | - Sterilization via gamma irradiation after final packaging.
• Validated to a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1 and ISO 11137-2 (VDmax25 method).
• Pyrogen limit specifications met with LAL Endotoxin Analysis, testing limit of 20 EU/device (per FDA Guidance and ISO 10993-1). |
  | Biocompatibility:
  Biological assessment performed according to ISO 10993-1 and FDA Guidance. | - Biological assessment performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." for each device. (Results are not detailed but the assessment was stated to be performed). |
  | Dynamic Fatigue:
  Assessment conducted per FDA guidance and ISO 14801. | - Dynamic fatigue assessment conducted according to FDA guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801.
• Test covers permanent restoration of implants without failure. (Results are not detailed but the assessment was stated to be performed). |
  | Insertion Performance:
  Demonstrated adequate insertion torque in different bone classes. | - Insertion tests performed for the subject implants.
• Showed adequate insertion torque in different bone classes when inserted according to the surgical procedure. (Results are not detailed but the assessment was stated to be performed). |
  | MR Safety:
  Evaluated for MR Conditional status. | - Obtained MR Conditional status per K180540.
• MR Conditional tests conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment." (Results are not detailed but the status was noted). |

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

The core of the "study" for the labeling changes, especially concerning the "smokers' claim," was a systematic literature review, not a direct clinical trial conducted by the applicant for this 510(k).

• Sample Size for Smokers' Claim: The literature review included data from 5 publications which collectively involved 251 SLActive implants placed in 237 patients.
• Data Provenance: The data came from published clinical studies. The document does not specify the exact country of origin for all studies, but at least two cited papers involve authors from China (Xiao, Chen), one from Saudi Arabia (Alsahhaf), and the ITT World Symposium (Chen 2017) was held in Switzerland. The studies are explicitly described as "clinical studies," implying they were prospective or retrospective clinical investigations.

For other non-clinical performance characteristics (sterility, biocompatibility, dynamic fatigue, insertion tests, MR safety), these appear to be internal bench tests and assessments conducted by the manufacturer, or previously established for the cleared predicate/reference devices. No specific sample sizes for these tests are provided in this summary, but it's stated that "No significant changes have been performed to the subject implants since clearance so previously cleared bench data continue to be representative."

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

• For the "smokers' claim" (literature review): The "ground truth" (i.e., the reported outcomes like adverse event rates and implant failure rates) was established by the authors of the original 5 clinical publications. The document does not specify the qualifications of these individual authors. However, given they are "published clinical studies," it's understood that dental/medical professionals (e.g., oral surgeons, periodontists, implantologists) would have conducted these studies and reported the outcomes.
• For the equivalence discussion of Indications for Use: The "ground truth" is established by comparing the proposed wording against the previously cleared wording in the primary and reference predicate devices, which were approved by the FDA based on clinical and scientific evidence at the time of their clearance. This comparison itself is performed by regulatory affairs experts on behalf of the manufacturer.

4. Adjudication Method for the Test Set

• For the "smokers' claim" (literature review): The adjudication of adverse events and implant failure rates was performed within each of the original 5 clinical studies. The specific adjudication methods used in those individual studies are not detailed in this 510(k) summary. Given the nature of scientific literature, these studies would typically involve clinical follow-up and assessment by the treating clinicians/researchers.
• For the Indications for Use equivalence: This is a comparison process, not a clinical adjudication. The equivalence of wording is assessed by regulatory experts against the historical FDA clearances.

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

• No, an MRMC comparative effectiveness study was NOT done. This submission is for labeling changes for dental implants, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Not applicable. This submission is for a medical device (dental implants), not a software algorithm or AI.

7. The Type of Ground Truth Used

• For the "smokers' claim": The ground truth was clinical outcomes data reported in peer-reviewed published clinical studies. These outcomes included adverse events (e.g., failure to osseointegrate, peri-implantitis, bone loss) and implant failure rates.
• For other performance tests (sterility, fatigue, etc.): The ground truth would be established through defined bench testing protocols and adherence to international standards (e.g., ISO, FDA guidance).

8. The Sample Size for the Training Set

• Not applicable. This submission is not for a machine learning or AI device that requires a training set. The "smokers' claim" was based on a literature review which leverages existing published clinical data, akin to an external validation set rather than a training set for the current submission.

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

• Not applicable. (See point 8.)

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Straumann® Variobase® Abutments: The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abutments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center.

Straumann® nice® Zirconia discs: Once finalized into a suitable design: n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch. n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units.

The purpose of this bundled premarket notification is to obtain regulatory clearance for the Straumann subject devices: Straumann® Variobase® Abutments (NHA) A two-piece abutment consisting of a Variobase (bottom half) and ceramic component (top half), Straumann® n!ce® Zirconia discs (EIH). Straumann® Variobase® Abutments are two-piece abutments. The Variobase is the bottom half of the two-piece abutment. The top half of the two-piece abutment is a CAD/CAM designed and manufactured ceramic component milled from Straumann n!ce Zirconia (ZrQ2), also subject to this submission as a material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base, forms a finished dental prosthesis. All digitally designed ceramic components for use with the Straumann Variobase abutments are intended to be sent to Straumann for manufacture at a validated milling center. The following materials are available within the digital workflow for the manufacturing of dental prosthetic restorations: (i) low translucency (LT), (ii) high translucency (HT), and (iii) extra high translucency (XT) n!ce Zirconia. The materials come in various shades (excluding White). Straumann Variobase abutments are available to interface with the following Straumann dental implant platforms: Regular Neck (RN), Wide Neck (WN), Regular CrossFit (RC), Wide Base (WB), Regular Base (RB), Narrow TorcFit (NT), Regular TorcFit (RT), Wide TorcFit (WT) and were previously cleared (K120822, K170356, K190082 and K200586). Straumann® n!ce® Zirconia discs are intended to be milled to produce prosthetic restorations for prepared natural teeth and endosseous dental implant abutments. The material is suitable for use in inlays, onlays, veneers, copings, crowns, and multi-unit restorations. Straumann n!ce Zirconia (ZrO2) discs will be offered in 3 translucencies: low translucency (LT), high translucency (HT) and extra high translucency (XT).

The provided text is a 510(k) summary for Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs. It describes the device, its intended use, and compares its technological characteristics and performance to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not describe a study involving a device that uses AI, nor does it discuss acceptance criteria and performance in the way typically expected for an AI/ML medical device submission (e.g., in terms of metrics like sensitivity, specificity, AUC, etc., or human reader performance with and without AI assistance). The "performance testing" section refers to mechanical and material testing (dynamic fatigue, static strength, biocompatibility, sterilization, flexural strength, chemical solubility, CTE, shrinkage factor) to demonstrate that the dental components meet established physical and biological standards.

Therefore, I cannot answer the questions about AI device performance, sample sizes for test sets, expert ground truth adjudication, MRMC studies, or training set details as this information is not present in the provided document.

Assuming this question is posed in the context of an AI/ML medical device, and the provided document is a misunderstanding, I will state explicitly that the document does not contain the requested information regarding AI device performance.

If the question implies that the dental devices themselves are the "device" in question and that their "acceptance criteria" pertain to their physical and material properties, then I can extract some relevant information as follows, though it won't perfectly match the structure of AI/ML device performance reporting.

Based on the provided text, the "device" refers to Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs, which are physical dental prosthetics and materials, not an AI/ML medical device. Therefore, the acceptance criteria and study descriptions do not involve AI performance metrics or human reader studies.

The acceptance criteria are primarily related to biocompatibility, mechanical strength, and material properties as per established international standards for dental materials and implants. The "study that proves the device meets the acceptance criteria" refers to non-clinical performance testing of these physical properties.

Here's an interpretation based on the document's content, tailored to the questions where applicable, but noting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

For the Straumann® n!ce® Zirconia discs, key mechanical properties are compared to predicate devices, and these represent the performance thresholds that align with ISO 6872 standards. The document implicitly states that the Straumann® Variobase® Abutments also met relevant standards (ISO 14801).

For Straumann® Variobase® Abutments, the document states that "Dynamic fatigue and static strength tests were conducted according to ISO 14801 and the FDA guidance document... and demonstrated the two-piece Straumann Variobase Abutments with Straumann n!ce Zirconia are equivalent to the primary predicate and reference devices." This implies meeting the strength and fatigue requirements of these standards.

Biocompatibility for both devices was confirmed with chemical characterization and in-vitro cytotoxicity testing according to ISO 10993-5, 10993-12, and 10993-18.

Sterilization process for the Abutments was validated according to ISO 17665-1, ISO 17665-2, and applicable FDA guidance.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the mechanical and biological "test sets." It refers to "tests" and "evaluations" that meet ISO standards, which inherently include sample size requirements, but these are not enumerated.
Data provenance is implicitly "non-clinical laboratory testing" by the manufacturer, or a validated testing partner. It is not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these studies is based on objective, standardized physical, chemical, and biological measurements performed in a laboratory, not expert human interpretation (like in imaging studies).

4. Adjudication method for the test set
Not applicable, as ground truth is established by objective measurements 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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
The ground truth used for these dental devices is based on established international standards (e.g., ISO 6872, ISO 14801, ISO 10993 series) for material properties, mechanical performance, and biocompatibility. This includes objective measurements of flexural strength, chemical composition, thickness, and results from in-vitro cytotoxicity tests.

8. The sample size for the training set
Not applicable. There is no concept of a "training set" for physical product testing in this context, as it's not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable.

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The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

All digitally designed copings and/or crowns for use with the Straumann® TLX Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Straumann® TLX Variobase® C abutments are two-piece abutments composed of the following components:

• . Straumann® TLX Variobase® C (Ti-base)
• Prosthetic Restoration (patient specific coping or crown) .
• . Basal Screw

The Straumann® TLX Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platform: NT (Narrow TorcFit), RT (Regular TorcFit), and WT (Wide TorcFit). The Straumann® TLX Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half material that is compatible with the Straumann® TLX Variobase® C abutments is IPS e.max CAD.

The provided document is a 510(k) Summary for a dental device, the "Straumann® TLX Variobase® C". This document describes the device, its intended use, and how it compares to predicate devices. It does not describe a study involving an AI/ML algorithm or its performance characteristics.

Therefore, I cannot provide the information requested in your prompt because the document does not contain details about:

• Acceptance criteria for an AI/ML device.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test or training sets for an AI/ML model.
• Ground truth establishment methods for AI/ML data.
• Expert consensus or adjudication for AI/ML performance evaluation.
• MRMC studies for AI/ML or human-in-the-loop performance.
• Standalone AI algorithm performance.

The "Performance Testing" section (Page 10, section {10}) refers to mechanical and software validation testing for a dental abutment, not an AI/ML algorithm. Specifically, it mentions:

• Dynamic fatigue and static strength tests (mechanical performance).
• Biocompatibility (material safety).
• Sterilization process validation.
• Software verification and validation for the abutment design library to ensure it operates within specified design limitations.

The software validation mentioned is to ensure the design software for the dental abutment (Sirona Dental CAD/CAM System) correctly applies design restrictions, not to evaluate an AI's diagnostic or predictive performance.

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