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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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The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

Straumann® CARES® Abutments CoCr are used for the restoration of Straumann dental implant platforms RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). The Straumann® CARES® Abutments CoCr allow for individual customization regarding function and esthetics. Straumann® CARES® Abutments CoCr are designed by the dental laboratory technician either by means of a conventional wax-up model that is subsequently scanned or by scanning the intraoral situation and designing the shape by using a Straumann-approved software (such as Straumann® CARES® Visual). The design data is then transferred to a Straumann central milling center where the fabrication of the customized abutment is carried out. The Straumann® CARES® Abutments CoCr can be directly veneered.

The provided text describes the regulatory filing for a dental implant abutment and does not contain information about an AI/ML device. Therefore, it's not possible to extract the requested details regarding acceptance criteria, study design for AI models, or expert ground-truthing. The document pertains to a traditional medical device (Straumann® CARES® Abutments CoCr) and its equivalence to predicate devices based on material, design, and mechanical performance testing.

However, I can extract the acceptance criteria and performance data for the traditional medical device as described:

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
• ISO 10993-5:2009 "Tests for in vitro cytotoxicity"
• ISO 10993-18 "Chemical characterization of materials" |
  | Veneering Performance | Performed per ISO 9693-1 "Dentistry – Compatibility testing – Part 1: Metal ceramic systems". |
  | Corrosion Resistance | Demonstrated according to ISO 10271:2011 "Corrosion test methods for metallic materials". |
  | Sterilization Validation | Carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10^-6 in accordance to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2. |
  | Design Limits | Max Angulation 30°, Minimum thickness 0.33mm. Minimum surface area requirements based on tooth position were also identical to the predicate. |

The following information is not present in the provided document, as it describes a non-AI medical device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the 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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Additional Study Information (from the document for the traditional device):

• Study Type: Bench testing (mechanical, material, biocompatibility, corrosion, sterilization).
• Clinical Studies: "No animal or human clinical studies were conducted."
• Ground Truth: For traditional device testing, "ground truth" is typically defined by established engineering and material science standards (e.g., ISO, ASTM) and manufacturing specifications.

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Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function.

Straumann CARES Screw-Retained Bridges and Bars are indicated for screw-retained restorations.

The Straumann CARES Screw-Retained Bars and Straumann CARES Screw-Retained Bridges are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms and Straumann Screw-Retained Abutments. The bars and bridges presented in the premarket notification submission (identified as “SRBB" for Screw Retained Bars and Bridges) are designed to interface with previously cleared screw-retained abutments (K133421). We also present "multi-level" bars and bridges in this submission designed to interface with any combination of screw-retained abutments (as cleared per premarket notification K133421), Bone Level (BL) implants (as cleared per premarket notification K062129) and Tissue Level (TL) implants (as cleared per premarket notifications K101465 and K112280) of the SDIS. When SRBB devices are attached directly to dental implants of the SDIS; the abutment/secondary part is an integral part of the SRBB device.

SRBB devices facilitate customization to meet the functional and esthetic requirements of the individual patient. They are patient-specific medical devices, i.e. they are designed by the clinician or dental technician and fabricated by Straumann specifically for an individual patient.

SRBB devices are designed via Straumann approved Computer Aided Design (CAD) software such as Straumann® CARES® Visual. After importing a scan of the patient model, the CAD software is used to generate digital restoration models incorporating the subject devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)- techniques.

This document describes the Straumann® CARES® Screw-Retained Bridges and Bars. The information provided is from a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical study.

Here's an analysis 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:

• Sample Size: Not explicitly stated. The document mentions "bench studies" and "dynamic fatigue test data," which typically involve a set number of samples for mechanical testing, but the exact quantity is not specified.
• Data Provenance: The document does not specify country of origin for the data. The data is retrospective in the sense that it relies on established standards (ISO 14801) and comparisons to previously cleared devices.

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

• This information is not applicable for this type of submission. The ground truth for this device is established through engineering and material science principles, compliance with ISO standards, and comparison to a predicate device's established safety and effectiveness through bench testing. Clinical expert consensus for "ground truth" (as in diagnostic accuracy studies) is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. As the "ground truth" is established through engineering and material standards, adjudication by human experts is not part of the evaluation process for this specific device.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical dental prosthetic device, not a diagnostic AI algorithm. Therefore, such a study was not performed.

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

• Not applicable. This device is a physical dental prosthetic, not a software algorithm or AI.

7. The Type of Ground Truth Used:

• For physical properties and performance (e.g., fatigue strength, material biocompatibility), the ground truth is established by engineering standards (e.g., ISO 14801), material specifications, and regulatory guidance documents. The device's performance is compared against the known performance and characteristics of the predicate device (K132844) to establish substantial equivalence.

8. The Sample Size for the Training Set:

• Not applicable. This submission focuses on a physical medical device, not a machine learning model that requires a training set. The "design" of the device is developed by engineers and clinicians using CAD software, not "trained" on data in the AI sense.

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

• Not applicable. See point 8. The "design" is based on anatomical considerations, biomechanical principles, and the functional requirements for dental restorations, as implemented through CAD software. There isn't a "ground truth" for a training set in the context of an AI algorithm here.

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