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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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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Keystone® Dental PrimaConnex® Implant System, Neodent® GM Implant System, Straumann® BLX Implant System, Implant Direct® Legacy® Implant System, Implant Direct® InterActive® Implant System, Implant Direct® RePlant® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the OEM Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multiunit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

The provided document is a 510(k) Summary for a dental device (Inclusive® Titanium Abutments). It details the device's technical characteristics and claims substantial equivalence to a predicate device based on non-clinical testing. However, it does not include specific quantitative acceptance criteria or detailed results of a study designed to compare the device performance against such criteria.

The document discusses "performance data" in general terms, referring to several non-clinical tests (Biocompatibility, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, and Use in MR Environment). It states that these tests were performed to "demonstrate substantial equivalence" and to "address questions related to substantial equivalence based on the differences in technical specifications," but it doesn't present the data in a way that allows for filling out the requested table of acceptance criteria and reported performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

The document explicitly states:

• "Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission."

This indicates that clinical trials with human subjects, which would typically involve expert ground truth establishment and detailed performance metrics comparing against specific acceptance criteria, were not part of this submission for substantial equivalence.

The "Mechanical Properties" section mentions:

• "Static load and fatigue testing of the implant/abutment assembly was considered according to the FDA Guidance Document, Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength for its intended use."

This implies that there were performance targets based on ISO 14801:2016 for fatigue strength, but the specific acceptance critiera (e.g., minimum fatigue strength in Newtons) and the actual reported performance values are not provided in this summary. It only states that the device "has sufficient strength."

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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment is designed to be used with LOCATOR FIXED and LOCATOR Attachment Systems for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. The LOCATOR Angled Abutment consists of various height abutment bodies with an integrated abutment screw. The attachment features are identical compared to LOCATOR Abutments of the LOCATOR High Retention Attachment System (LOCATOR FIXED), cleared in K213391. The LOCATOR Angled Abutment is compatible with Straumann BLX Implant System cleared in K173961. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment uses identical attachment features as the LOCATOR Abutments, but instead of the attachment features being aligned coaxially, the interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the device of K190040. The LOCATOR Angled Abutments and integrated abutment screw are manufactured from titanium (Ti-6Al-4V). The LOCATOR Angled Abutment body is titanium nitride (TiN) coated, identical to LOCATOR Abutments.

The provided FDA 510(k) summary for the "LOCATOR Angled Abutment" does not describe a study involving an AI/Machine Learning (ML) device or any specific performance metrics for such a device like sensitivity, specificity, or AUC, or a comparative effectiveness study involving human readers.

This submission is for a medical device (dental implant abutment) and focuses on demonstrating substantial equivalence to a predicate device through physical and mechanical testing, material compatibility, and intended use.

Therefore, I cannot provide a detailed answer to your request based on the provided text, as the information required (acceptance criteria for an AI/ML device, details of an AI/ML study, ground truth establishment, expert adjudication, MRMC studies, etc.) is not present.

In summary, the document does not contain the information needed to answer your questions regarding acceptance criteria and performance of an AI/ML device.

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The Straumann CARES P-Series CAD/CAM System 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, a restorative acrylic resin, 3D printers, post-curing unit and associated accessories. The system is used to design and fabricate CAD/CAM 3D printed coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments that are affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

The Straumann P pro Crown & Bridge material in combination with the Straumann Variobase is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.

The Straumann CARES P-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow for 3D printing.

The Straumann CARES P-Series CAD/CAM System employs optical impression files that document the topoqraphical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the desired restorations. The CAM software converts the digital restoration design into the sequential slice geometries needed to 3D print a restoration or multiple restorations in a print job. The printing file is transferred to the Straumann P-Series 3D printer; where it is decoded into the defined printing slices and the user initiates the printing operation. The Straumann P-Series 3D printer will then print the designed restoration using the Straumann P Pro Crown & Bridge resin.

The user of a Straumann CARES P-Series CAD/CAM System can design dental implant borne restorations using Straumann Variobases as the connecting interface to the implant. By this, the user will create two-piece abutments with the 3D printed part being the upper part of the implant borne restoration.

The provided text is a 510(k) summary for the Straumann CARES P-Series CAD/CAM System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the manner of a clinical trial or performance study comparing a new algorithm's efficacy.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/algorithm-based device is not explicitly available in this document. The device in question is a CAD/CAM system for designing and fabricating dental restorations, not an AI diagnostic tool.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for a specific performance metric in the context of an AI algorithm. Instead, it describes "Design Specifications" which serve as internal parameters for the CAD/CAM system and performance testing related to mechanical properties.

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

This information is not provided in the document. The testing described primarily involves mechanical material testing and software verification, not clinical or diagnostic data analysis. Therefore, concepts like "test set" in the context of an AI algorithm are not applicable here.

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

This information is not applicable as the document describes a CAD/CAM system for fabricating dental prosthetics, not a diagnostic AI algorithm requiring expert ground truth for imaging or clinical decision support. The "ground truth" for the mechanical characteristics would be established by standardized testing protocols.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as in point 3.

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

This information is not applicable. The device is a CAD/CAM system for fabrication, not an AI for human reader assistance or diagnostic interpretation.

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

The "standalone" performance described relates to the verification of the 3D printer system and the CAD software.

• Software Verification and Validation: This was performed to demonstrate that the software's restrictions prevent designing components outside allowable limitations and that the design library is locked. This implies a standalone verification of the software's adherence to design rules.
• 3D Printer System Verification: This confirmed that "the design input matched the output, that the process is repeatable and independent of print orientation, build plate location effects, and the effects of material reuse." This is a form of standalone performance assessment for the manufacturing component.

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

The "ground truth" for the performance testing cited appears to be:

• Standardized Mechanical Testing: According to FDA guidance for dental implants and abutments. This involves objective measurements of strength and fatigue.
• Material Specifications: Biocompatibility data from a previously cleared 510(k) for the P pro Crown & Bridge material (K200039).
• Design Specifications: Defined parameters (e.g., minimum wall thickness, maximum angulation) that the CAD software must adhere to.

This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI diagnostic systems.

8. The sample size for the training set

This information is not provided and is not applicable as the device is not an AI/machine learning algorithm requiring a "training set" in the conventional sense.

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

This information is not provided and is not applicable for the same reasons as in point 8.

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The Straumann CARES M-Series CAD/CAM System 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, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

The Straumann CARES M-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow. The workflow is unchanged from the primary predicate K171649. This premarket notification is introducing the Straumann Variobase Abutments for the BLX implant to abutment interface to the previously cleared workflow.

The Straumann CARES M-Series CAD/CAM System employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual 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. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.

This premarket notification includes restorations (copings, and bridges) manufactured from Zolid HT/Zolid SHT materials for cementation on Straumann Variobase Abutments for the BLX implant system. The BLX dental implant platforms include RB (Regular Base) and RB/WB (Regular Base/Wide Base). The combination of the coping, crown, or bridge and the Variobase Abutment component make up a two-piece abutment assembly, which is used in conjunction with endosseous dental implants for single or multiple tooth dental prostheses.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Specific sample sizes for the test set of the dynamic fatigue tests, milling system validation, and simulated use validation are not explicitly stated in the provided document.

The document mentions that the studies were "leveraged from K171649" (the primary predicate device) and that "the subject devices were not considered a new worst case." This implies that the validation data was likely historical or previously collected for the predicate device.

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective or Prospective: Not explicitly stated, but "leveraged from K171649" suggests a retrospective application of existing data and validation reports.

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

This information is not provided in the document. The studies mentioned are primarily engineering and performance tests (dynamic fatigue, dimensional accuracy, sterilization efficacy) and do not involve human expert interpretation of device output in a diagnostic or clinical context to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are performance and engineering validations, not studies involving human interpretation or clinical adjudication.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned in the document. The device described is a CAD/CAM system for fabricating dental prosthetics, which is a manufacturing process, not an AI-powered diagnostic or interpretive tool that would typically be evaluated with MRMC studies.

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

The "Milling System Validation" and "Simulated Use Validation" could be considered forms of standalone performance evaluation for the CAD/CAM system's components (software outputs, milling accuracy).

• Milling System Validation: Confirmed "the dimensions of the milled restoration were the same as the intended CAD design from CARES Visual." This evaluates the algorithm's (CAD/CAM software's) ability to translate digital design into physical form, without human intervention in the final output quality check for the purpose of this specific validation.
• Simulated Use Validation: Confirmed "the scan, design, and production capability of the subject devices in CARES Visual." This also assesses the system's performance in a simulated workflow.

The dynamic fatigue tests evaluate the physical product, not directly the algorithm's performance.

7. The Type of Ground Truth Used

• Dynamic Fatigue Test: Ground truth is established by the specified FDA guidance document regarding performance requirements for dental implants and abutments. This involves objective physical testing against performance standards.
• Milling System Validation: The "intended CAD design from CARES Visual" serves as the ground truth against which the milled restoration is compared for dimensional accuracy.
• Simulated Use Validation: The expected functional capability of the system (scan, design, production) serves as the ground truth.
• Sterilization Process Validation: The ground truth is adherence to the validated sterilization parameters and expected sterility assurance levels as defined by the FDA guidance document.

8. The Sample Size for the Training Set

This information is not provided in the document. The device is a CAD/CAM system, and while CAD/CAM software development might involve training (e.g., machine learning for design optimization or material properties), the submission focuses on validating the manufacturing process and the final product's performance, not the training of an AI model in the typical sense. The "training set" for the CAD/CAM system would implicitly be the engineering data and design principles embedded in the software.

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

As above, this information is not provided. If there were any AI/ML components in the CAD/CAM software that involved "training," the method for establishing ground truth for that training is not discussed. For the broader CAD/CAM system's engineering and design, the ground truth would typically be established through established engineering principles, material science, and preclinical testing to ensure precise and functional designs.

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Straumann TLX Implants are suitable for endosteal implantation in the upper and for the functional and esthetic oral rehabilitation of edentulous patients. TLX Implants can be placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.

TLX Closure Caps and Healing Caps:
Straumann Closure Caps and Healing Caps are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure caps and healing caps should be used only with suitable implant connections. They have a maximum duration of usage of 6 months.

TLX Temporary Abutment:
TLX Temporary Abutments can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. TLX Temporary Abutments have a maximum duration of usage of 180 days.

TLX Variobase for Crown:
Straumann Variobase prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann Variobase prosthetic components. A temporary restoration can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseontegrated. All digitally designed copings and/or crowns for use with the Straumann Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

TLX CARES Abutment TAN:
The Straumann CARES Abutments TAN are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

TLX Screw-retained Bridges and Bars:
CARES Screw-retained Bridges and Bars (SRBB) are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-retained Bridges and Bars are indicated for Screw-retained restorations. Straumann CARES Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), BLX implants of the Straumann Dental Implant System (SDIS).

TLX Dental Implant:
The TLX Dental Implant are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive surface. The connection is identified as conical fitting with Torx style engaging feature. TLX implants are presented with 3 prosthetic platforms as listed below:

• NT (Narrow TorcFit)
• RT (Regular TorcFit)
• WT (Wide TorcFit)
  The internal connection is identical for all prosthetic platforms, implant diameters, and implant lengths.

TLX Closure Caps and Healing Caps:
The closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submucosal) healing protocols. The healing caps are screwed into the implant to protect the inner configuration of the implant in cases of transmucosal healing protocols. They are placed out of occlusion and do not support a prosthetic restoration. Closure caps and healing caps are used during the healing phase only.
The TLX Closure Caps and Healing Caps are manufactured from Titanium Grade 4 and are laser marked with NT, RT or WT for identification purposes. They are provided sterile and are available in different heights and diameters.

TLX Temporary Abutment
TLX Temporary Abutments can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion.
TLX Temporary Abutments have a maximum duration of usage of 180 days.
The TLX Temporary Abutments are manufactured from TAN and consist of a coronal section, a platform and a connection part. The abutments are provided non-sterile with instructions for end user sterilization. The Temporary Abutments are seated in the implant with a basal screw which is also manufactured from TAN and are laser marked with NT, RT or WT for identification purposes. The Basal screw is delivered with the abutment. The TLX Temporary Abutments are available for Crown and Bridge/Bar restorations.

TLX Variobase for Crown
The TLX Variobase for Crown incorporates the implant to abutment connection (TorcFit) and is available for each of the three implant diameter platforms (NT, RT & WT) with a different abutment chimney height and prosthetic platform diameter. The TLX Variobase Abutments for Crown are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. These components, which once assembled together and placed with the corresponding basal screw, constitute the final medical device.
TLX Variobase for Crown will be marketed as stand-alone component or through the CARES® X-Stream workflow. In the latter the prosthetic restoration is designed though CARES® Visual software (Digital CARES workflow) and manufactured in a validated Straumann milling center. The prosthetic restoration is then shipped together with the TLX Variobase for Crown and the Basal screw.
All digitally designed copings and/or crowns for use with the TLX Variobase for Crown are intended to be sent to Straumann for manufacture at a validated milling center.
The TLX Variobase for Crown is provided non-sterile with instructions for end user steam sterilization.

Prosthetic Restoration Design and Materials
The following materials are available within the digital workflow for the manufacturing of prosthetic restorations:
Final restorations:

• zerion® LT
• zerion® ML
• zerion® UTML
• IPS e.max CAD
• coron®
  Temporary restoration:
• polycon® ae

TLX CARES Abutment TAN
The TLX CARES Abutments TAN are packed and delivered with the Basel screw. Both are manufactured from TAN (titanium-aluminum-niobium alloy/ Ti-6AI-7Nb).
TLX CARES Abutments TAN are intended to be placed into Straumann implants to provide support for prosthetic reconstructions such as crowns and bridges.
The final abutment, fabricated from a pre-milled blank, is designed to allow for individual customization regarding function and esthetics.
The pre-milled blank incorporates the pre-milled implant to abutment connection (TorcFit) and has a cylindrical body with enough material volume to create a wide range of geometries for the final abutment.
The TLX CARES Abutments TAN is available for each of the three implant platforms.

TLX Screw-retained Bridges and Bars:
The Straumann CARES Screw-retained Bridges and Bars, also referred to as SRBB are packed and delivered with the corresponding basal screws.
SRBB devices are manufacture from either

• Titanium Grade 4 or
• Cobalt chromium (also referred to as CoCr (or coron).
• the Basal Screw is manufactured from TAN (titanium-aluminum-niobium alloy/ Ti-6Al-7Nb).
  SRBB are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms.
• CARES bars are to be combined with an overdenture to treat edentulous cases.
• CARES fixed bars are superstructures for the direct application with dental resin and prefabricated teeth to treat edentulous cases.
• CARES Screw-retained Bridges are intended to be directly veneered with dental veneering ceramics.
  The purpose of this premarket notification is to expand the currently cleared abutment-toimplant interfaces to include the TLX implant system.
  The SRBB devices are available for each of the three prosthetic platforms (NT, RT, WT).
  The design of the SRBB devices must be made using the validated Straumann CARES Visual software (Digital CARES workflow).
  Finally, the design file is transferred digitally to a Straumann validated milling center.

TLX Basal screw
The Basal screw is used to seat the temporary abutments, the TLX Variobase Abutments or the TLX Screw-retained Bridges and Bars to the dental implant and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. They are provided along the prosthetic components, but they are also provided as standalone screws. The TLX basal screws is manufactured from TAN.

The provided document is an FDA 510(k) premarket notification for the Straumann TLX Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance testing (bench testing, biocompatibility, sterilization, and software validation).

Crucially, this document does not contain information about a study proving that the device meets specific acceptance criteria in terms of human-in-the-loop performance with AI assistance, or standalone algorithm performance, as would be expected for an AI/ML medical device submission.

The document describes a dental implant system (a physical device), not an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, the questions related to AI/ML device performance (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, training/test set sample sizes for AI, etc.) are not applicable to the content of this 510(k) submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the device's ability to meet the substantial equivalence criteria established by the FDA for its intended use, when compared to legally marketed predicate devices. This is demonstrated through various tests and comparisons, as outlined in section 5.7 "Performance Testing".

However, to answer your request as literally as possible, based on the information provided for this non-AI/ML device, I will extract the relevant "acceptance criteria" and descriptions of "studies" as they pertain to a traditional medical device submission for a physical product.

Based on the provided document (K200586 for the Straumann TLX Implant System), which describes a physical dental implant system and not an AI/ML medical device, the following information can be extracted:

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to existing predicate devices, as required for a 510(k) submission. The "studies" are the performance tests conducted to support this claim of substantial equivalence.

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

Since this is not an AI/ML device, the acceptance criteria are not in terms of traditional metrics like accuracy, sensitivity, or specificity for an algorithm. Instead, they relate to mechanical, biological, and processing characteristics that are equivalent or superior to predicate devices.

• Tests performed in saline (2 Hz, 37°C) for 2 million cycles (permanent) and 200,000 cycles (temporary).
• Tests performed in air (15 Hz) for 5 million cycles (permanent) and 500,000 cycles (temporary). |
  | Endosseous Surface Area & Pull-Out Force (for specific implants) | TLX Dental Implant: "Surface area comparison and pull-out testing were performed on the Ø3.75 x 6 mm NT implants and were determined to have a larger endosseous surface area and higher pull-out force compared to the reference Ø4.1 x 6 mm device." |
  | Biocompatibility | All TLX Components: "Biological assessment has been performed according to ISO 10993-1:2009... and to the FDA Guidance document... The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised." |
  | Sterilization Assurance Level (SAL) for Sterile Components | TLX Implants & Healing/Closure Caps (Sterile): "A sterility assurance level (SAL) of 10-6 had been validated in accordance with ISO 11137-1:2006... The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013." |
  | Pyrogenicity Limit | TLX Implants & Healing/Closure Caps (Sterile): "The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device." (Note: The device is not marketed as non-pyrogenic but pyrogenicity info is provided.) |
  | End-User Sterilization Validation (for Non-Sterile Components) | TLX Temporary Abutments, Variobase for Crown, CARES Abutment TAN, SRBB (Non-Sterile): "The recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'." "There are no changes to the sterilization procedures or processes from those of the Straumann predicate devices." |
  | Software Validation (for CAD/CAM components) | Software for CAD/CAM: "Software validation testing were conducted and documentation was provided according to the FDA guidance documents 'Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations' and 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff'. The software for this device was considered as a 'moderate' level of concern." |
  | Material Equivalence | TLX Dental Implant: Roxolid® (Titanium-13 Zirconium alloy), same as primary predicate.
  TLX Closure Caps/Healing Caps: Titanium Grade 4, same as primary predicate.
  TLX Temporary Abutment, Variobase, CARES Abutment TAN, Basal Screw: TAN (Ti-6Al-7Nb), same as predicate/reference.
  TLX Screw-retained Bridges and Bars: Titanium Grade 4 or Cobalt Chromium, with TAN screw. Materials consistent with predicate devices. |
  | Surface Treatment Equivalence | TLX Dental Implant: Hydrophilic SLActive®, same as primary predicate. |
  | Implant-to-Abutment Connection Equivalence | TLX Dental Implant: TorcFit (with conical fitting), same as primary predicate. |
  | Manufacturing Workflow Equivalence (for CAD/CAM components) | Variobase for Crown, CARES Abutment TAN, SRBB: "Straumann Milling" / "Digital CARES workflow via Straumann milling center", consistent with predicate/reference. |
  | Design Workflow Equivalence (for CAD/CAM components) | Variobase for Crown, CARES Abutment TAN, SRBB: "Digital CARES workflow (CAD)" / "Straumann CARES Visual", consistent with predicate/reference. |
  | Indications for Use Equivalence (with minor expansions/clarifications demonstrated via testing) | TLX Dental Implant: Broadly equivalent to predicates, with expansion to "multi-unit restorations" which is supported by testing.
  TLX Closure Caps/Healing Caps: Equivalent.
  TLX Temporary Abutment: Equivalent.
  TLX Variobase for Crown: Equivalent.
  TLX CARES Abutment TAN: Equivalent.
  TLX Screw-retained Bridges and Bars: Expanded to include "TLX implants", supported by device design and testing for new interface. |

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

• Sample Sizes: The document does not specify exact sample sizes for all performance tests (e.g., how many implants were used for dynamic fatigue testing, or how many software test cases were run). For dynamic fatigue, it mentions cycles (2 million, 200,000, 5 million, 500,000 cycles). For surface area and pull-out, it refers to "the Ø3.75 x 6 mm NT implants," but not a specific count.
• Data Provenance: The document does not specify the country of origin for the test data, nor does it explicitly state if the testing was retrospective or prospective. Given it's premarket notification for a physical device, the "data" would primarily come from laboratory bench testing rather than 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 question is not applicable to this type of device submission. Ground truth established by experts (like radiologists) is relevant for AI/ML devices that interpret medical images or data. For this dental implant system, "ground truth" refers to the physical and mechanical properties of the device, which are established through standardized engineering and biocompatibility tests, not human expert consensus on clinical data.

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

• This question is not applicable to this type of device submission. Adjudication methods are used in studies involving human interpretation (e.g., reading medical images) to resolve discrepancies and establish a consensus ground truth, typically for AI/ML performance evaluation. This document describes physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable to this type of device submission. MRMC studies are specifically designed to evaluate the impact of AI on human reader performance in diagnostic tasks. This is a physical dental implant.

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

• This question is not applicable to this type of device submission. Standalone performance refers to the accuracy of an AI algorithm on its own. This is a physical dental implant, not an algorithm. (Note: Some CAD/CAM software is mentioned, but "standalone performance" in the AI context isn't relevant here; rather, the software's functionality and output are validated against engineering standards.)

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

• For this physical device, the "ground truth" for the performance claims comes from standardized laboratory testing and engineering measurements in controlled environments (e.g., dynamic fatigue machines, material analysis instruments, biological assays). There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for the technical equivalence claims presented in the 510(k). The clinical indications are based on established dental practice and the equivalence to predicate devices which have a history of clinical use.

8. The sample size for the training set

• This question is not applicable to this type of device submission. "Training set" refers to data used to train an AI/ML algorithm. This document does not describe an AI/ML component.

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

• This question is not applicable to this type of device submission as there is no AI/ML training set.

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Indications for Use for NUVO IF Implants and conventional abutments:

The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.

Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:

Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement or screw-retained single or multi-unit restorations or screw-retained single restorations.

All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.

Indications for Use for CARES® Abutment IF:

The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cementretained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

The NUVO IF Implant System consists of implants, cover screws, and abutments.

Implants: Intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), bone level design, apically tapered thread-form with apical cutting flutes in various diameters and lengths, and provided with an internal hexagonal implant-to-abutment interface.

Cover Screws: Intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants.

Abutments: Intended for single use, provided sterile via ethylene oxide gas or non-sterile, manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy, conical format available in different diameters, height of cementable area and gingival height, screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions, and Titanium Base abutments are two-piece abutments composed of a titanium base and a patient-specific CAD/CAM top-half.

This looks like a 510(k) summary for a dental implant system (NUVO IF Implant System), not a study describing acceptance criteria and performance data for an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI device.

The document discusses:

• Trade/Device Name: NUVO IF Implant System
• Regulation Number/Name: 21 CFR 872.3640, Endosseous Dental Implant
• Regulatory Class: Class II
• Product Code: DZE, NHA
• Indications for Use: Surgical placement in maxilla or mandible for prosthetic device support, including immediate loading, temporary support, and attachment of dentures.
• Device Description: Details on implants (material, design, size, sterilization), cover screws (material, use, sterilization), and various abutment types (materials, design, sterilization, use).
• Predicate Devices: Several predicate devices are listed and compared for substantial equivalence.
• Performance Data: This section details non-AI/ML performance testing, including:
  • Dynamic fatigue testing per ISO 14801.
  • Sterilization validation (gamma irradiation per ISO 11137-1/2, ethylene oxide per ISO 11135, moist heat per ISO 17665-2).
  • Ethylene oxide residuals testing per ISO 10993-7.
  • Biological Safety Assessment per ISO 10993-1 (cytotoxicity per ISO 10993-5, chemical characterization per ISO 10993-18).
  • Package transport integrity per ISTA 2A.
  • Product and package stability per ASTM F1980.
  • Product endotoxin testing (LAL) per ANSI/AAMI ST72.

There is no mention of an AI/human-in-the-loop study, ground truth establishment, sample sizes for training/test sets for AI, or expert adjudication.

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Straumann® Mini Implants ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Strauman® Mini Implants are intended for the stabilization of removable dentures.

The Straumann Mini Implants are tapered implants with an external diameter of 2.4 mm and lengths of 10, 12, and 14 mm. Standard manufacturing processes such machining, surface treatment, cleaning, packaging and sterilization were applied for the subject devices. There are no significant changes related to the implant material, surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the reference devices cleared under K083550. The main difference is the Optiloc® attachment element incorporated on the top of the implant. The implants are manufactured utilizing the Roxolid material and are finished with SLA® surface. The implant neck is machined and the Optiloc® attachment element of the implants is acting as a retention feature for dentures and it is coated using a Titanium Nitride (TiN) coating. Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. The Straumann Mini Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the Mini Implants through the incorporated Optiloc® attachment element.

This document describes a 510(k) premarket notification for the Straumann® Mini Implants. The information provided heavily focuses on the comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device's performance against specific quantitative acceptance criteria in a human population.

Therefore, many of the requested details regarding acceptance criteria for device performance in a clinical setting, sample sizes for test sets, expert involvement for ground truth, and MRMC studies will not be present in this type of regulatory submission. The performance testing outlined here is primarily bench testing to demonstrate mechanical and material equivalence.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The document does not specify quantitative clinical performance acceptance criteria (e.g., success rates, complication rates) and corresponding reported device performance from a clinical trial. Instead, the "acceptance criteria" discussed are related to bench testing for demonstrating equivalence to predicate devices.

Table 1: Acceptance Criteria (Bench Testing) and Reported Device Performance

Study Details (Based on Provided Document)

Given that this is a 510(k) submission primarily relying on substantial equivalence through bench testing, a traditional clinical study with a "test set" in the context of AI/diagnostic device evaluation (as implied by the detailed questions) was not conducted or reported here. The performance testing discussed pertains to physical and mechanical characteristics of the dental implants.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a clinical test set for AI/diagnostic performance. The "test set" here refers to the samples of the physical device used for bench testing (e.g., number of implants for insertion torque, wear, and fatigue tests). Specific quantities are not provided, but these are typically small, controlled laboratory samples.
   • Data Provenance: Not applicable in terms of patient data. The data provenance is from laboratory bench testing.

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

   • Not applicable. Ground truth for a physical device's mechanical properties is established through standardized engineering tests, not expert consensus on medical images or clinical outcomes.

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

   • Not applicable. This concept applies to human reader studies or data labeling, not bench testing of a physical implant.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is irrelevant to the evaluation of a dental implant's mechanical and material properties. The device is a physical implant, not an AI-assisted diagnostic tool.

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

   • No. This also refers to AI/software performance, not a dental implant.

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

   • The "ground truth" for this device is based on engineering standards and specifications (e.g., ISO 14801, ISO 11137), and the properties of the previously cleared predicate devices. For example, a successful fatigue test to a certain threshold is "ground truth" for mechanical durability.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As noted above, there is no training set for this type of device.

Summary of what the document primarily reports:

The document, a 510(k) summary, demonstrates the substantial equivalence of the Straumann® Mini Implants to legally marketed predicate devices. This is achieved by:

• Comparing Indications for Use: Showing the new device's indications are equivalent to a predicate (K031106), with one difference (not indicated for inter-radicular transitional applications) that does not raise new safety or effectiveness questions.
• Comparing Technological Characteristics: Detailing similarities and differences in material, dimensions, coating, surface treatment, etc., with predicates and reference devices (Table 1).
• Performance Testing (Bench Testing): Conducting various engineering tests (insertion torque, wear, biocompatibility, sterilization, shelf life, pyrogenicity, dynamic fatigue) and demonstrating that the device meets internal "acceptance criteria" for these tests, which are implicitly set to show equivalence to or non-inferiority against the predicate devices' known performance. The tests adhere to relevant FDA guidance and ISO standards.

This type of submission is common for Class II medical devices where clinical trials are not explicitly required if substantial equivalence can be demonstrated through non-clinical means.

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