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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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Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patient-specific prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical 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. Temporary restorations are indicated to be placed out of occlusion. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann® Variobase™ for Bridge/Bar Cylindrical, see Figure 1 and Table 1, are non-engaging (without rotational lock) abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.

This document is a 510(k) premarket notification for a medical device called "Straumann® Variobase™ for Bridge/Bar Cylindrical". It does not describe a study that uses software, AI, or machine learning. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not applicable to the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and bench testing (dynamic fatigue, software validation, sterilization validation, and biocompatibility testing) for a dental implant abutment. The "Software validation conforming to the requirements of IEC 62304" mentioned in the Performance Data section refers to the validation of software used in the manufacture of the device (specifically, for digitally designed components intended to be sent to a validated milling center), not a clinical performance or diagnostic AI component of the device itself.

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Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications 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.

Straumann® Closure Caps and 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 shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.

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® 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 (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. 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. 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.

The Straumann BLX Implants 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. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths.

The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for the parts compatible with the RB platform and brown for the parts compatible with the WB platform for identification purposes. Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion.

The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification purposes. The temporary abutments are fixed in the implant with a basal screw which is also manufactured from TAN. The basal screw will be delivered with the temporary abutment.

BLX Variobase abutments is a two-piece abutment ultimately composed by three components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping and/or crown), and Basal Screw. The BLX Variobase Abutments are manufactured and are delivered with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components.

Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN.

This document describes the Straumann® BLX Implant System, a dental implant system, and its various components. The information provided is for a 510(k) premarket notification to the FDA. The goal is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific, quantitative acceptance criteria for novel performance. Instead, the "acceptance criteria" are implied by successful comparative testing and adherence to existing standards and guidance documents. The "reported device performance" is the outcome of these tests.

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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.

The Straumann® Variobase® for Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).

There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.

The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.

There are three components to the Straumann® Variobase® for Crown AS:

• . Straumann® Variobase® for Crown AS (Ti-base)
• o Prosthetic restoration (coping and/or crown)
• o Basal Screw

Here's an analysis of the provided text regarding the Straumann® Variobase® for Crown AS, focusing on acceptance criteria and the study proving it meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., "device must perform at X% accuracy"). Instead, it focuses on demonstrating substantial equivalence to predicate devices through various performance tests and material comparisons. The "acceptance criteria" can be inferred as successful completion of the listed tests and demonstrating comparable performance or safety profiles to the predicates.

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

The document does not provide details on the specific sample sizes for the test sets (e.g., number of units tested for fatigue, number of software test cases). It broadly states that "bench studies" were conducted.

• Sample Size: Not explicitly stated for performance tests.
• Data Provenance: The studies were internal "bench studies" conducted by Institut Straumann AG. The country of origin of the data is not specified, but the applicant is Institut Straumann AG (Switzerland), with a US contact address. The studies appear to be prospective as they were conducted to support the 510(k) submission.

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

This information is not applicable in this context. The device is a physical dental implant component, not an AI/software device requiring expert interpretation for "ground truth" establishment of medical images or patient data. The "ground truth" for performance is based on established engineering standards (ISO, FDA guidance) and validated testing methods.

4. Adjudication Method for the Test Set

This is not applicable. As a physical device undergoing performance and material testing, there is no need for an adjudication method as would be relevant for clinical studies or AI diagnostic tools involving human interpretation.

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

No, an MRMC comparative effectiveness study was not conducted and is not applicable for this type of device. An MRMC study is typically used for diagnostic devices (e.g., AI in radiology) where the performance of human readers with and without AI assistance is being evaluated. This device is a dental implant abutment, not a diagnostic tool.

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

No, a standalone algorithm performance study was not conducted and is not applicable. This is a physical medical device, not a standalone algorithm. Its function is to be physically implanted and support dental restorations. While it supports digitally designed copings, the device itself is not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards, material science properties, and validated test methods. Specifically:

• Dynamic fatigue testing: Conformance to ISO 14801 and FDA guidance. This standard dictates how fatigue life is measured and evaluated.
• Software validation: Conformance to IEC 62304 for medical device software lifecycle processes.
• Sterilization validation: Conformance to ISO 17665-1 and ISO/TS 17665-2.
• Biocompatibility: Likely conformance to ISO 10993 series.
• Material specifications: Ti-6Al-7Nb alloy properties.

These standards and specifications define the "truth" against which the device's physical and functional performance is measured.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical component. It does not employ machine learning or AI that requires a "training set" of data in the conventional sense. The "training" for this device involves its design, engineering, and manufacturing process based on established dental implant principles.

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

This is not applicable for the same reasons as #8. There is no training set or ground truth in the context of machine learning for this device. The design and validation are based on engineering principles and regulatory standards.

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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 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.

The provided document describes the acceptance criteria and the study that proves the Straumann CARES M-Series CAD/CAM System meets those criteria, primarily through a substantial equivalence comparison with predicate devices and various bench studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, performance is demonstrated through a claim of "equivalence" to predicate devices, which implicitly means meeting the performance standards of those legally marketed devices. The reported device performance is presented as "Equivalent" for various features when compared to predicate devices.

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

The document does not specify a separate "test set" sample size in the context of clinical studies with patients. The studies conducted are primarily bench studies involving laboratory testing of materials and device components. The number of samples for each type of bench test (fatigue, biocompatibility, etc.) is not detailed in this summary, but these are typically standardized tests with a defined number of specimens as per the relevant ISO or FDA guidance.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" clinical data, as it primarily refers to bench testing data. These tests would have been performed in a controlled laboratory environment.

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

This information is not applicable. The evaluations are based on engineering and material performance specifications (bench studies) and comparison to predicate devices, not on expert clinical review of a test set for establishing ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable, as the evaluation is based on bench testing and comparison to technical specifications, not human adjudication of diagnostic data.

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

This information is not applicable. The device is a CAD/CAM system for fabricating dental prosthetics, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to improving human reader performance with AI is not relevant to this submission.

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

The document describes the Straumann CARES M-Series CAD/CAM System as an integrated system involving CAD software, CAM software, milling machines, and material blanks. The "algorithm" component is the CAD/CAM software. The system's performance is inherently "standalone" in its function of designing and fabricating prosthetics based on input scan files, but it is a tool used by human operators (dental technicians/laboratories). The bench studies performed evaluate the output of this system (e.g., strength of the milled prosthetics), which indirectly assesses the standalone performance of the algorithms and hardware in creating the physical restorations.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench studies, the "ground truth" refers to established engineering and material standards. Specifically:

• Dynamic fatigue testing: Conforming to FDA guidance and ISO 14801. The ground truth is the performance criteria defined by these standards.
• Software validation: Conforming to the requirements of IEC 62304. The ground truth is compliance with this software safety standard.
• Sterilization validation: Conforming to ISO 17665-1 and ISO/TS 17665-2. The ground truth is achieving sterility assurance levels defined by these standards.
• Biocompatibility testing: Conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-18. The ground truth is meeting the safety criteria for biological interaction.
• Electrical safety testing: Conforming to IEC 61010-1 and IEC 61010-2-010. The ground truth is compliance with electrical safety standards.

For the substantial equivalence comparison, the "ground truth" is the performance and characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning. The CAD/CAM software is likely based on computational design and manufacturing principles, not on a machine learning model that requires a labeled training set derived from large datasets of past cases. Therefore, this concept is not applicable here.

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

As there is no "training set" in the machine learning sense, this question is not applicable. The underlying principles for the software's functionality would stem from dental anatomical knowledge, engineering mechanics, material science, and manufacturing tolerances, which form the basis of its deterministic operation.

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The Straumann® Variobase® Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. 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.

The purpose of the subject submission is to add the previously cleared Straumann n!ce glass ceramic material (K160262) as a cleared material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base (K142890), forms a finished dental prosthesis. The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The coping and/or crown would be manufactured via traditional laboratory methods for pressing or casting, or via validated Straumann milling.

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The Straumann® Variobase Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. 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.

The purpose of the subject submission is to add the zerion® ML and zerion® UTML Zirconia ceramic materials as a material suitable for fabrication of the coping, crown or bridge that, when bonded to the previously cleared Variobase abutment base (K120822, K142890), forms a finished dental prosthesis. The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The restoration will be manufactured via validated Straumann milling.

The provided document is a 510(k) summary for the Straumann® Variobase® Abutments, an endosseous dental implant abutment. The primary purpose of this submission is to add new Zirconia ceramic materials (zerion® ML and zerion® UTML Zirconia) as suitable materials for fabricating the coping, crown, or bridge that attach to the Variobase abutment base.

Here's an analysis of 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:

The document outlines performance data related to the physical and biological characteristics of the device rather than traditional clinical performance (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC). The acceptance criteria are based on compliance with established standards and guidance documents.

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

• Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of abutments for fatigue testing, number of samples for cytotoxicity). It only states that "Bench testing was performed."
• Data Provenance: All testing appears to be retrospective bench testing conducted in vitro (laboratory setting) and pre-clinical. There is no indication of human or animal studies. The country of origin of the data is not explicitly stated but is implied to be conducted by or for Institut Straumann AG, a Swiss company with a US subsidiary.

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

• This information is not applicable in the context of this submission. The "ground truth" for the acceptance criteria mentioned (e.g., material compliance, fatigue limits, sterility, biocompatibility) is established by international standards (ISO) and FDA guidance documents, not by individual experts establishing a "ground truth" on a test set in the same way an expert would for a diagnostic AI device. The tests themselves are designed to measure against these established benchmarks.

4. Adjudication Method for the Test Set:

• This information is not applicable. Since the "ground truth" is based on objective standards and measurement rather than expert interpretation of complex data (like medical images), there is no need for an adjudication method among experts.

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

• No, an MRMC comparative effectiveness study was not done. This type of study assesses reader performance with and without AI assistance for diagnostic tasks. The Straumann® Variobase® Abutments are a physical implant component, not a diagnostic AI device.

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

• No, this is not applicable. The device is a physical medical component, not an AI algorithm. While software validation was performed, it relates to the design and manufacturing software, not a standalone AI diagnostic tool.

7. The Type of Ground Truth Used:

• The "ground truth" for the acceptance criteria is based on established regulatory standards, consensus standards (ISO), and FDA guidance quantitative limits and requirements. For example:
  • Material: ISO 5832-11 for titanium alloys.
  • Dynamic Fatigue: FDA guidance document for Class II Endosseous Dental Implants and Abutments, which sets performance thresholds.
  • Biocompatibility (Cytotoxicity, Extractables): ISO 10993 series standards.
  • Sterilization: ISO 17665 series standards and FDA guidance.
  • Software: FDA guidance and IEC 62304.

8. The Sample Size for the Training Set:

• This information is not applicable. This submission is for a physical medical device, not a machine learning model that requires a training set. The term "training set" is relevant for AI/ML device development.

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

• This information is not applicable for the same reasons as point 8.

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Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants 02,9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications 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 components (abutments).

The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant comection.

Straumann® SC Temporary Abutments are indicated 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. Strauman® SC Temporary Abutments have a maximum duration of usage of 180 days.

Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when 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 manufacture at a validated milling center.

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

The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implants with an external diameter of Ø2.9 mm and lengths of 10 mm, 12 mm, and 14 mm. The implants are manufactured utilizing the Roxolid material and are finished with either the SLA® or SLActive® surface. The prosthetic platform is identified as SC (Small CrossFit®) which corresponds to a shoulder diameter of Ø2.9 mm.

The closure cap and healing abutments are manufactured from Titanium Grade 4 and are anodized blue for identification purposes. The closure cap is conical and has a height of 0.5 mm. The healing abutments are seated in the implant with a basal screw which is manufactured from TAN. The healing abutments are oval in shape and are available in four different heights ranging between 2.0 mm and 6.5 mm.

The temporary abutments are manufactured from TAN and are anodized blue for identification purposes. The temporary abutments are oval in shape in order to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The temporary abutments are seated in the implant with a basal screw which is also manufactured from TAN.

There are three components to the Straumann® SC Variobase™ Abutments:

• Straumann® SC Variobase™ Abutments (Ti-base)
• Prosthetic restoration (coping and/or crown)
• Basal Screw

The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.

The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:

• Cast materials:
  • Type 4 metals (ISO 22674)
  • Base metal alloys (e.g., cobalt-chromium (CoCr))
  • Noble metal alloys (e.g., gold alloy)
• Press materials:
  • IPS e.max® Press Ceramic (K120053)
• Digital materials:
  • coron®
  • zerion® LT
  • polycon® ae

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.

The Straumann® SC CARES® Abutments are customized abutments manufactured from TAN. The abutments are designed by the customer by scanning the intraoral situation and designing of the shape with the CAD module of the integrated software. The design data is then sent to Straumann where the fabrication of the customized abutment is performed. The TAN alloy is capable of being directly veneered once the abutment is subject to a heat treatment step by the dental laboratory technician. A finished crown may also be cemented to the subject abutments rather than by direct veneer. The abutments will be delivered with the corresponding basal screw.

The provided document (K162890) describes the regulatory submission for Straumann dental implants and associated components. However, it does not contain information about studies proving the device meets acceptance criteria for performance metrics related to diagnostic accuracy, such as sensitivity, specificity, or AUC, as these types of metrics are typically associated with diagnostic or AI-powered devices.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through various non-clinical tests. The "acceptance criteria" here relate to the successful completion of these engineering and safety tests, rather than clinical performance metrics for diagnostic capability.

Therefore, the requested information cannot be fully provided in the format desired for diagnostic devices because this submission deals with dental implants, not a diagnostic AI.

However, I can extract the information related to the performance testing that was conducted to support the substantial equivalence claim.

Acceptance Criteria and Device Performance (Not applicable in the typical sense for diagnostic AI):

The document does not present acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) because the devices (dental implants and abutments) are not diagnostic AI devices. Instead, the "performance testing" focuses on engineering, biocompatibility, and sterilization validations to demonstrate substantial equivalence to predicate devices.

Summary of Performance Testing Conducted (which can be seen as meeting "acceptance criteria" for safety and efficacy in this context):

1. Sterilization Validation (Section 5.8.1):

   • Acceptance Criteria: Validation according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
   • Reported Device Performance: The sterilization process for SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments was validated.

2. Biocompatibility Testing (Section 5.8.2):

   • Acceptance Criteria: Compliance with ISO 10993-1:2009 and the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016". The subject devices should have identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices, raising no new biocompatibility issues.
   • Reported Device Performance: The subject devices have identical biocompatibility characteristics to the primary and reference predicate devices. Therefore, no additional biocompatibility testing was required or performed.

3. Software Verification and Validation Testing (Section 5.8.3): (Applicable to CARES Visual software for abutment design, which is part of the manufacturing process, not a diagnostic AI)

   • Acceptance Criteria: Compliance with 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".
   • Reported Device Performance: Software verification and validation testing were conducted; the software for the device (CARES Visual) was considered a "moderate" level of concern.

4. Bench Testing (Section 5.8.4):

   • Acceptance Criteria: Compliance with the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for dynamic fatigue, static strength, and insertion torque tests.
   • Reported Device Performance: Dynamic fatigue, static strength, and insertion torque tests demonstrated the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Temporary Abutments, SC Variobase Abutments, and SC CARES abutments are equivalent to the predicate and reference devices.

Regarding the specific questions about diagnostic AI studies:

1. A table of acceptance criteria and the reported device performance: As explained above, not applicable for diagnostic metrics. The performance relates to engineering and safety tests.
2. Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical engineering and bench tests, not studies on patient data for diagnostic evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no diagnostic test set or ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a diagnostic AI scenario. The "ground truth" for the bench tests would be the established engineering standards and physical properties of the materials.
8. The sample size for the training set: Not applicable, as there is no AI training set.
9. How the ground truth for the training set was established: Not applicable.

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

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

This submission includes the Titanium Base abutments (two-piece hybrid abutments) and the superstructures that compose the final abutment (the second part of the two-piece abutment).

The Titanium Base abutments are provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). They have a Morse taper implant-to-abutment interface and an additional hexagonal indexing feature at the apical end of the Morse taper connection. The surface is as-machined, without any type of treatment surface. The Titanium Base abutment is an intermediary prosthetic component between the implant and prosthesis; a CAD/CAM abutment design to be used as a base when fabricating a coping, crown or bridge superstructure. It is a stock abutment, previously cleared per K150367. The subject abutments are compatible with Neodent dental implants having Morse taper (CM) implant-to-interface cleared under K101945, K123022, K133592, K133592, K150182 and K150199.

The purpose of this submission is to expand the range of materials allowed in fabricating the superstructure, adding Co-Cr and IPS e.max "CAD materials to the previously cleared portfolio.

A dental laboratory equipped with an appropriate CAD system, will design a customized superstructure or restoration made of zirconia, IPS e.max CAD or Co-Cr. Each patient-specific superstructure is individually prescribed by the clinician. The minimum wall thickness of the structure is variable depending on the material, according to the table below. The maximum angling of the structure should not exceed 30°. The taper of the structure should not exceed 6°. In the case of a structure angled at the height of the cementable portion starting at the emergence profile (prosthetic height), it should not exceed 10 mm for the Morse Taper.

The provided text is a 510(k) Pre-Market Notification for a medical device (Neodent Implant System - Titanium Base Abutment) to the FDA. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not describe an acceptance criteria table related to performance metrics for a study outcome using accuracy, sensitivity, or specificity, nor does it provide a study that proves the device meets such criteria in the context of an AI/ML or diagnostic device.

The document focuses on demonstrating that the new features of the Neodent Implant System (specifically, the expanded range of materials for superstructures: Co-Cr and IPS e.max CAD) are substantially equivalent to a previously cleared predicate device. The performance data presented are primarily engineering and sterilization validations, not clinical or diagnostic performance metrics.

Therefore, for aspects related to acceptance criteria and studies demonstrating device performance typically associated with AI/ML or diagnostic devices (such as sensitivity, specificity, or accuracy with ground truth validation), the information is not present in the provided text.

Here's an analysis of the information that is available based on your request:

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

No such table is provided in the document for performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" for this submission are related to demonstrating substantial equivalence through:

• Identical Indications for Use (with minor wording differences considered equivalent)
• Identical Mechanical Design Parameters (Abutment Diameter(s), Implant-to-Abutment Connection, Compatibility, Mode of attachment, Restoration Angulation(s), Gingival Height(s))
• Identical Abutment Material (Titanium-aluminum-vanadium alloy Ti-6Al-4V)
• Equivalent Superstructure Materials (Addition of Co-Cr and IPS e.max CAD, arguing equivalence based on widespread dental use and existing predicate devices)
• Identical Sterility and Sterilization by End User

The reported device performance primarily revolves around non-clinical testing to support mechanical integrity, sterilization effectiveness, and biocompatibility.

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

This information is not provided in the document. The document refers to "engineering analysis, and dimensional analysis" and "mechanical testing," "sterilization validation." These are typically laboratory-based tests with specific sample sizes for specimens, but these details are not disclosed. No patient data (test set) is mentioned.

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 information is not applicable as there is no diagnostic test set or ground truth established by experts described in this document. The submission is for a dental implant abutment, not an AI/ML or diagnostic device requiring expert interpretation of results.

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

This information is not applicable as there is no diagnostic test set or adjudication process described.

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 as the device is a dental implant abutment, not an AI-assisted diagnostic or imaging interpretation device.

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

This information is not applicable as the device is a physical medical device (dental implant abutment), not an algorithm or software.

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

This information is not applicable as there is no ground truth, expert consensus, pathology, or outcomes data used for performance evaluation in the context of diagnostic accuracy. The "ground truth" for this device's performance would be the physical properties and material specifications, which are assessed through engineering and bench testing.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML model that requires a training set.

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

This information is not applicable as this is a physical medical device, not an AI/ML model.

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Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.

TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.

Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series.

The provided document is a 510(k) premarket notification for Medentika CAD/CAM Abutments, asserting substantial equivalence to legally marketed predicate devices. It does not describe a study involving an AI/ML powered device, nor does it detail acceptance criteria related to such a device's performance. Instead, it focuses on non-clinical testing to demonstrate safety and effectiveness for a dental abutment. Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies from this document.

The "Performance Data" section (Page 6/7) explicitly states the types of non-clinical testing conducted:

• Engineering analysis and dimensional analysis: To determine compatibility with original manufacturers' components.
• Static and dynamic compression-bending testing: According to ISO 14801 (Dentistry – Implants – Dynamic fatigue test for endosseous dental implants).
• Sterilization testing: According to ISO 17665-1 and ISO 17665-2 to demonstrate an SAL of 10^-6.
• Biocompatibility testing: For cytotoxicity according to ISO 10993-5.

The acceptance criteria would be the successful completion of these tests in accordance with the specified ISO standards and demonstrating compatibility and performance comparable to the predicate devices. However, the document does not list the quantitative acceptance criteria or the specific numerical results obtained for each test (e.g., specific fatigue life, or precise dimensional tolerances met).

In summary, the document does not contain the information required to answer the prompt as it pertains to AI/ML device performance. The device is a physical medical device (dental abutments), and the review is for substantial equivalence based on physical and mechanical properties, not an AI/ML algorithm.

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