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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.

Ask a specific question about this device

Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
Multi-unit Abutments are used for the restoration of the following dental implant systems:
Medentika series EV-Series, Implant system Dentsply® Implants - ASTRA TECH OsseoSpeed®, Implant diameter 3.6, 4.2, 4.8, Platform diameter 3.6, 4.2, 4.8
Medentika series F-Series, Implant system Nobel Biocare NobelActive - NobelReplace Conical, Implant diameter 3.5, 4.3, 5.0, Platform diameter NP 3.5, RP 4.3/5.0
Medentika series H-Series, Implant system Biomet 3i - Certain, Implant diameter 3.25, 4.0, Platform diameter 3.4, 4.1
Medentika series L-Series, Implant system Straumann - Bone Level, Implant diameter 3.3, 4.1, 4.8, Platform diameter 3.3, 4.1, 4.8
Medentika series N-Series, Implant system Straumann - Soft Tissue Level, Implant diameter 4.1, 4.8, Platform diameter 4.8, 6.5
Medentika series R-Series, Implant system Zimmer Dental Tapered Screw-vent, Implant diameter 3.3, 3.7, 4.1, 4.7, Platform diameter 3.5, 4.5

The proposed Multi-unit Abutments are dental abutments, which are intended to be screwed onto osseointegrated dental implants to provide support for prosthetic suprastructures on the gingival level. Multi-unit abutments can be 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. Multi-unit abutments are very similar to the already FDA-cleared Straumann Screw-Retained Abutment System. Multi-unit abutments are available as straight abutments, which have an integrated thread and can be screwed directly into the implant, or as angled abutments, which can be screwed onto the implant with the corresponding abutment screw. All models of Multi-unit abutments have a universal interface for a variety of prefabricated prosthetic parts, e.g. Multi-unit caps, which become part of the superstructure and ensure a low-tension screw connection of the multi-unit prosthetics.
The Multi-Unit caps or base are used in conjunction with the Multi-Unit Abutment. The Multi-Unit Abutment is considered the bottom half of a two-piece abutment and the Multi-Unit Caps or Multi-Unit Titanium base are considered the top half of the two-piece abutment.
Multi-unit Abutments exist in two model types: straight multi-unit abutments without rotational indexing with various gingival heights and platform diameters and angled multi-unit abutments with rotary indexing with various ginqival heights and platform diameters.

The provided document is a 510(k) premarket notification for "Multi-unit Abutments." This document establishes substantial equivalence to predicate devices based on technological characteristics and performance testing. However, it does not describe a study that proves the device meets specific acceptance criteria related to AI/algorithm performance in a diagnostic or interpretive context.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" outlined in the request (e.g., MRMC study, ground truth, expert consensus, sample size, effect size) are typically attributes of studies supporting AI/ML-driven medical devices that output a diagnostic or interpretive result. The device described in this 510(k) is a physical dental implant component, not a software or AI device.

Therefore, I cannot extract the requested information regarding AI/algorithm performance. The provided text outlines:

• Device Description: Multi-unit abutments are dental components screwed onto implants to support prosthetic suprastructures (e.g., bridges, bars).
• Performance Testing: This refers to mechanical and biological testing (e.g., dynamic fatigue, static strength, biocompatibility, sterilization) to ensure the physical device's safety and effectiveness, not the performance of an AI algorithm.
• Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new device is as safe and effective as previously cleared predicate devices through comparisons of indications for use, design, materials, and mechanical properties.

Specifically, here's why the requested information cannot be provided from the text:

1. Acceptance Criteria/Reported Device Performance (Table): The document provides a table of "Technological Characteristics" comparing the subject device to predicates, but these are design and material specifications, not performance metrics for an AI algorithm (e.g., sensitivity, specificity, AUC).
2. Sample Size and Data Provenance: Not applicable for an AI test set. The document discusses "test sets" in the context of mechanical fatigue and static strength tests (e.g., testing multiple abutment units), but not a dataset of images or patient cases for AI evaluation.
3. Number of Experts/Ground Truth Establishment/Qualifications: Not applicable. There's no AI component requiring expert review for ground truth.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable. This device is a physical component, not an AI assisting human readers.
6. Standalone Performance: Not applicable. There is no AI algorithm to evaluate in standalone mode.
7. Type of Ground Truth Used: Not applicable. Ground truth for an AI would involve labeled data (e.g., disease presence/absence from pathology), which is irrelevant for a dental abutment.
8. Sample Size for Training Set: Not applicable.
9. Ground Truth for Training Set: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (dental abutments), which successfully demonstrates substantial equivalence based on engineering and biocompatibility standards. It does not involve any artificial intelligence or machine learning component, and thus the acceptance criteria and study details relevant to AI performance are absent.

Ask a specific question about this device

Straumann BLX Healing Abutments for Bars and Bridges: Straumann Healing abutments 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 to form, maintain and stabilize the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. Healing components have a maximum duration of usage of 6 months.

Straumann BLX Temporary Abutments for Bars and Bridges: Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components 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. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.

Straumann BLX Variobase Abutments for Bar and Bridges: Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or overdenture) can be cemented on the Straumann® Variobase® prosthetic components. 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. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

Straumann BLX Variobase Abutments AS: The Straumann Variobase for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase for Crown AS 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. All digitally designed copings and/or crowns for use with the Straumann Variobase for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.

Straumann BLX Novaloc Abutments: The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants.

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

BLX Healing Abutments for Bars and Bridges: Healing abutments are screwed into the implant in cases of transmucosal healing to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. They are placed out of occlusion and have a maximum duration of usage of 180 days. Unlike the predicate RB/WB healing abutments (K173961), the subject healing abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of single crowns. The subject healing abutments are manufactured from Titanium Grade 4 and are anodized in violet.

BLX Temporary Abutments for Bars and Bridges: Temporary Abutments are intended to be placed into Straumann dental implants to provide support for temporary restorations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase, as well as provide a temporary esthetic solution. They support a temporary restoration and may not be placed into of occlusion. Straumann BLX Temporary Abutments have a maximum duration of usage of 180 days. Unlike the predicate RB/WB temporary abutments (K173961), the subject temporary abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of sinqle crowns. The subject temporary abutment cannot be shortened. The Temporary abutment for bar/bridge is a non-engaging device intended to support multiple-unit restoration. The subject temporary abutment is manufactured from TAN and is anodized in violet. The temporary abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.

BLX Variobase Abutments for Bars and Bridges: Variobase Abutments for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations. The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. A temporary restoration can be used prior to the insertion of 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 osseointegrated. Unlike the predicate Variobase abutments (K173968), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The Variobase abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations. The subject Variobase abutments are manufactured from TAN and are anodized in violet. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.

BLX Variobase Abutments AS for Crowns: Variobase abutments AS for crowns are intended to be placed into Straumann implants to provide support for single-unit restorations. The prosthetic restoration (crown) must be cemented onto the Variobase abutment, which is then screwed onto the implant. A temporary restoration can be used prior to the insertion of 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 osseointegrated. The Variobase abutments are manufactured from TAN and are anodized in violet or in brown according to the compatible BLX implant platform (RB/WB or RB). Unlike the predicate Variobase abutments (K173961/K173379), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The chimney presents a cutout window to facilitate the handling of the screw driver in an angulated position. The Variobase abutments AS for crown are engaging devices intended to support single-unit restorations. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN. The Variobase abutments for crown AS 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. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center.

BLX Novaloc Abutments: Novaloc Abutments are intended to be placed into Straumann dental implants to provide support for full arch detachable restorations (over-denture). The Novaloc abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium) and are anodized in violet. The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. Unlike the reference Novaloc abutments (K173902), the subject Novaloc abutments are not only provided in a straight version but also angulated. The Novaloc abutments are provided non-sterile with instructions for end user sterilization. Angled models: are composed of an abutment body with a coupled basal screw. They are engaging devices. Straight models: both body and thread parts are machined in one piece. They are nonengaging devices.

BLX CARES Abutments: CARES Abutments 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 blank, manufactured from TAN and CoCr, is composed of a pre-milled implant-toabutment connection (TorcFit) and a cylindrical body with enough material volume to create a wide range of geometries for the final abutment. Inside the abutment, a screw channel provides access to the internal thread feature of the implant, such that the component can be firmly attached while providing fit between screw, abutment and implant. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. The maximum angulation allowed is 30° and the minimum wall thickness allowed is 0.4 mm. All digitally designed abutments are intended to be manufactured at a validated milling center.

BLX Basal Screws: Basal screws are used to fix abutments to dental implant, and can also be used during lab procedures to fix lab prosthetic parts on implant analogs. They are provided along the abutments and also provided as standalone screws. The subject Basal Screws are manufactured from TAN. The Basal Screw for Variobase AS is anodized in green since this color identifies Straumann devices pertaining to AS system.

The provided 510(k) summary for the Straumann® BLX Line Extension - New Abutments is a pre-market notification to the FDA. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance targets.

Instead of "acceptance criteria," the focus here is on bench testing performance demonstrating fundamental material and structural integrity compared to predicate devices, and lack of significant differences in technological characteristics and indications for use.

Therefore, the requested information elements related to clinical studies, test sets, ground truth, and expert adjudication are not applicable in the context of this 510(k) summary, as no device-specific clinical data has been submitted to demonstrate substantial equivalence. The submission relies on performance data from bench testing and biocompatibility assessments to support the claim of substantial equivalence.

Here's the information that can be extracted from the provided text, re-interpreting "acceptance criteria" as the comparable characteristics to predicate devices and "reported device performance" as the results of the bench and biocompatibility tests.

Acceptance Criteria and Study Details for Straumann® BLX Line Extension - New Abutments

As this is a 510(k) submission primarily relying on substantial equivalence to predicate devices, the concept of "acceptance criteria" is less about meeting specific numerical performance targets in a clinical setting and more about demonstrating that the new devices do not raise new questions of safety or effectiveness. The study supporting this is primarily bench testing and biocompatibility assessments, rather than a clinical trial.

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

The "acceptance criteria" for a 510(k) are implicitly that the new device's technological characteristics and performance are substantially equivalent to a predicate device, without raising new questions of safety or effectiveness. The "reported device performance" refers to the results of the bench tests and sterility/biocompatibility validations.

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