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Anthogyr FlexiBase® titanium bases for Axiom® BL are indicated for use as a support for singleunit customized prosthetic restorations. All digitally designed copings and / or crowns for use with the Anthogyr Flexibase® titanium bases for Axiom® BL are intended to be sent to Straumann for manufacturing by a validated milling center (Straumann CARES System).

Anthogyr FlexiBase® titanium bases for Axiom® BL are intended to be placed into Anthogyr dental implants to provide support for single-unit restorations. The second component of the two-piece abutment (coping or crown) must be cemented onto the titanium component of the FlexiBase® abutment to constitute the final two-piece abutment design, which is then screwed onto the implant.

The bottom portion of the FlexiBase® are made from Titanium alloy. They are provided in several dimensions, there is one chimney height, and two platform diameters of 4.0 mm and 5.0 mm, and for each of the platform diameters there are three gingival heights of 1.5 mm, 2.5 mm and 3.5 mm.

Anthogyr FlexiBase® titanium bases for Axiom® BL are very similar to the primary predicate device Medentika TiBase CAD/CAM Abutments cleared in K150203.

The FlexiBase® are fixed in the implant by means of a prosthetic screw which is manufactured in titanium alloy and DLC coated identical to K161177.

The FlexiBase® abutments are two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. The design and milling of the customized restoration must be made using the Straumann CARES® Visual software.

The FlexiBase® is a two-piece abutment ultimately composed by three components:

• . FlexiBase® abutment titanium component
• Top-half component (coping and/or crown) .
• . Prosthetic screw

The FlexiBase® abutments will be marketed:

• through a validated Straumann Centralized milling center, in this case all digitally . designed copings and/or crowns are intended to be manufactured at a validated Straumann milling center (Straumann CARES® System).

The provided text describes a 510(k) premarket notification for "Anthogyr FlexiBase® titanium bases for Axiom® BL". This document focuses on demonstrating substantial equivalence to predicate devices, and therefore, the acceptance criteria and study detailed below relate to the performance of the device in comparison to these predicates, rather than proving a specific diagnostic accuracy or clinical outcome for a novel AI algorithm.

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

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

The document does not detail specific "sample sizes" in the context of a statistical test set using patient data. The performance testing described relates to in-vitro bench testing of the devices themselves.

• Dynamic Fatigue Testing: The document states the test was conducted on the devices, but the specific number of units tested is not provided ("the subject devices").
• Data Provenance: Not applicable in the context of clinical patient data. The testing described is laboratory-based bench testing.

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

This information is not applicable. The device is a physical dental implant component, and the testing described is engineering performance testing (sterilization, biocompatibility, fatigue). There is no "ground truth" to be established by clinical experts in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as this is laboratory bench testing, not a clinical study involving human judgment on a test set.

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. The device is a dental implant base, not an AI, imaging, or diagnostic device that would involve human readers or AI assistance.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. The performance criteria are based on engineering standards and regulatory guidance for device performance and safety (e.g., ability to withstand dynamic loading, biocompatibility, sterility) rather than clinical "ground truth" derived from patient data or expert consensus on clinical findings.

8. The sample size for the training set

Not applicable. This is not an AI algorithm or a device requiring a training set in that sense.

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

Not applicable.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed under "Performance Testing - Bench" and "Performance Testing 1.1 - Sterilization Validation and Shelf-life", as well as "Biocompatibility Testing" and "Electromagnetic Compatibility".

• Study Design: The studies essentially comprised benchtop engineering tests performed according to recognized international standards and FDA guidance documents. This included:

  • Sterilization Validation: Demonstrated the effectiveness of the recommended moist heat (steam) sterilization method for end-users, aligning with ISO 17665-1, ISO 17665-2, and FDA guidance.
  • Biocompatibility Testing: Conducted biological assessment according to ISO 10993-1 and ISO 10993-5, including cytotoxicity testing. The materials were deemed equivalent to those in predicate devices, implying comparable biocompatibility.
  • Electromagnetic Compatibility (EMC): Assessed by confirming no significant changes in materials and dimensions compared to previously cleared predicate devices, thus inferring MR Conditional status based on prior clearances (e.g., K180564).
  • Dynamic Fatigue Testing: Conducted in accordance with FDA guidance for endosseous dental implants and ISO 14801. This involved cyclic loading tests in saline (2 Hz, 37°C) for:
    • 2 million cycles for permanent restorations (without failure).
    • 200,000 cycles for temporary restorations (without failure).

• Proof of Meeting Acceptance Criteria: The outcome of these tests indicated that the "Anthogyr FlexiBase® titanium bases for Axiom® BL" devices successfully met the performance requirements outlined by the respective standards and guidance documents. The key finding was that the subject devices demonstrated equivalence to the primary predicate and reference devices in all these aspects of performance and safety. This equivalence is the primary basis for the 510(k) clearance.

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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 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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