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The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Zirconia Base abutment is used as two-piece abutment, where the base is premanufactured from zirconia and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The top half and base pieces are cemented together to form the final abutment. This submission aims to introduce the conventional workflow for obtaining prostheses manually designed by the technician using the Zirconia Bases, already cleared under K201491. With that, the introduction of one more restoration material (IPS e.max® Press) for the top half confection is necessary. The conventional workflow, using the IPS e.max® Press as restoration material along with the suggested cement materials is equivalent to the design workflow indicated for reference device (K142890).

The provided text describes the regulatory clearance of a dental implant system and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML device. Therefore, the information requested for an AI/ML device, such as specific acceptance criteria and detailed study designs involving test sets, ground truth establishment, and expert involvement, is not available in the provided document.

The document primarily discusses:

• Device: Neodent Implant System - Zirconia Implant System, specifically the Zirconia Base abutment.
• Purpose of Submission: To introduce a conventional workflow for manually designed prostheses using Zirconia Bases and to include a new restoration material (IPS e.max® Press).
• Method of Proof: Substantial Equivalence to legally marketed predicate devices, as per FDA 510(k) requirements. This involves comparing indications for use, technological characteristics, materials, and manufacturing processes, supported by performance data (mechanical testing, MR compatibility, sterilization validation, biocompatibility) demonstrating that the new workflow and material do not raise new questions of safety or effectiveness.

Therefore, I cannot populate the requested tables and information as it pertains to AI/ML device acceptance criteria and study details. The document does not describe an AI/ML device or its evaluation.

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The BioClean Implant Restorative System is designed to support fixed/detachable partial or full arch restorations on endosseous dental implants in the maxilla for the purpose of restoring masticatory function. It is used in fixed/detachable restorations that can be attached with a friction-based engagement system.

All digitally designed copings for use with the BioClean Implant Restorative System are to BioClean Dental or a validated milling center for manufacture.

The BioClean Implant Restorative System is compatible with the following:

The BioClean Implant Restorative System provides rigid connection of partial and full arch restorations to endosseous dental implants in the mandible or maxilla.

The BioClean Implant Restorative System consists of copings, denture housings, and retention inserts that are intended to allow for a fixed/detachable prosthesis to be connected to OEM multiunit abutments for stable attachment of the prosthesis to endosseous dental implants. All BioClean copings are made of titanium alloy and have the same coronal ridge retention design that attaches to the prosthesis component by a friction-based engagement system. The subject device coping connects to the OEM multi-unit abutment and is specific to each compatible abutment system and diameter.

The subject device copings are offered with angulation from 0° to 9° in 0.5° increments and also in a patient specific version in which the dental laboratory technician designs the coping in CAD software and then sends the design to BioClean Dental or a validated milling center for fabrication from a coping blank. By use of a combination of pre-manufactured and patientspecific versions of the copings, a multi-unit prosthesis can be created in which the copings are parallel.

The provided text is a 510(k) Summary for a dental device, the BioClean Implant Restorative System. It details the device's indications for use, technological characteristics, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria, the specific study design (e.g., sample sizes for training/test sets, data provenance), expert involvement, or statistical analysis of device performance against defined criteria, which would typically be found in a clinical study report or a more detailed performance evaluation.

The document states that "Non-clinical testing data submitted to demonstrate substantial equivalence included:" and then lists several types of tests:

• Sterilization validation
• Biocompatibility testing
• Mechanical testing (ISO 14801 for dynamic loading of dental implants)
• Reverse engineering to verify OEM compatibility
• Retention testing
• Non-clinical worst-case MRI review

While "Retention testing was conducted to ensure that retention is maintained throughout the expected use of the product. Retention strength of the subject devices was tested and compared to the retention strength of reference device K033699," this is the only mention of a quantitative comparison to a reference device's performance, but it does not provide acceptance criteria or the actual performance values.

Therefore, I cannot fully answer your request based on the provided text. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison of fundamental device characteristics and indications for use, rather than presenting a performance study against explicit acceptance criteria with detailed statistical results.

Here's what can be extracted and what is missing based on your prompts:

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

Cannot be fully provided from the text. The document states that "Retention testing was conducted to ensure that retention is maintained throughout the expected use of the product. Retention strength of the subject devices was tested and compared to the retention strength of reference device K033699." However, it does not explicitly define acceptance criteria (e.g., "retention strength must be X N or within Y% of predicate") nor does it report the specific measured retention strength values for either the subject device or the reference device.

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

Not available in the text. The document describes non-clinical laboratory testing, but does not specify the sample size for any of the tests (e.g., number of devices tested for retention, number of samples for biocompatibility). Data provenance (country of origin, retrospective/prospective) is also not mentioned, but given it's non-clinical lab testing, it's typically done in a controlled environment and not tied to patient data provenance in the same way clinical studies are.

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

Not applicable/Not available. This document describes non-clinical engineering and biological performance testing of a physical medical device (dental implant components). Ground truth as established by experts (e.g., radiologists interpreting images) is not relevant to the types of tests described here (mechanical, biocompatibility, sterilization validation).

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

Not applicable/Not available. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, often for establishing ground truth from multiple readers. This is not relevant to the non-clinical lab testing 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

Not applicable. This device is a physical dental implant restorative system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable/Implicit in testing standards. For mechanical testing (ISO 14801), the "ground truth" is defined by the physical properties and performance metrics specified in the standard. For biocompatibility (ISO 10993), the "ground truth" for safety is determined by the absence of cytotoxic effects or other adverse biological responses as per the standardized test protocols. For sterilization, it's documented sterility assurance levels. This is not "ground truth" in the sense of clinical diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is hardware, not a machine learning algorithm that requires a training set. The term "training set" would apply if this were an AI or software device.

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

Not applicable. As above, no training set is involved for this hardware device.

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The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

All digitally designed copings and/or crowns for use with the Straumann® TLX Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Straumann® TLX Variobase® C abutments are two-piece abutments composed of the following components:

• . Straumann® TLX Variobase® C (Ti-base)
• Prosthetic Restoration (patient specific coping or crown) .
• . Basal Screw

The Straumann® TLX Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platform: NT (Narrow TorcFit), RT (Regular TorcFit), and WT (Wide TorcFit). The Straumann® TLX Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half material that is compatible with the Straumann® TLX Variobase® C abutments is IPS e.max CAD.

The provided document is a 510(k) Summary for a dental device, the "Straumann® TLX Variobase® C". This document describes the device, its intended use, and how it compares to predicate devices. It does not describe a study involving an AI/ML algorithm or its performance characteristics.

Therefore, I cannot provide the information requested in your prompt because the document does not contain details about:

• Acceptance criteria for an AI/ML device.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test or training sets for an AI/ML model.
• Ground truth establishment methods for AI/ML data.
• Expert consensus or adjudication for AI/ML performance evaluation.
• MRMC studies for AI/ML or human-in-the-loop performance.
• Standalone AI algorithm performance.

The "Performance Testing" section (Page 10, section {10}) refers to mechanical and software validation testing for a dental abutment, not an AI/ML algorithm. Specifically, it mentions:

• Dynamic fatigue and static strength tests (mechanical performance).
• Biocompatibility (material safety).
• Sterilization process validation.
• Software verification and validation for the abutment design library to ensure it operates within specified design limitations.

The software validation mentioned is to ensure the design software for the dental abutment (Sirona Dental CAD/CAM System) correctly applies design restrictions, not to evaluate an AI's diagnostic or predictive performance.

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The Straumann® Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

All digitally designed copings and/or crowns for use with the Straumann® Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Straumann® Variobase® C abutments are two-piece abutments composed of the following components:

• . Straumann® Variobase® C (Ti-base)
• . Prosthetic Restoration (patient specific coping or crown)
• . Basal Screw

The Straumann® Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platforms: RC (Regular CrossFit®), NC (Narrow CrossFit®), NNC (Narrow Neck CrossFit®), RB/WB(Regular Base/Wide Base), and WB (Wide Base). The Straumann® Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half materials that are compatible with the Straumann Variobase C abutments include IPS e.max CAD, inCoris ZI, and n!ce. The top half material compatibility is dependent on the dental implant platform, with inCoris Zl and n!ce only being compatible with the RC (Regular CrossFit®) and NC (Narrow CrossFit®) platforms.

The provided text describes a 510(k) premarket notification for a dental device, the "Straumann® Variobase® C." It details the device's characteristics, intended use, indications for use, and a comparison to predicate devices. The section titled "Performance Testing 1.8" provides information on the studies conducted to demonstrate the device meets acceptance criteria.

Here's an analysis of the provided information against your requested criteria:

Based on the provided text, there is no information related to an AI/ML-based medical device performance study. The device described, Straumann® Variobase® C, is a dental abutment, which is a physical component used with dental implants. The performance testing mentioned (Dynamic fatigue and static strength tests, biocompatibility, sterilization process) are standard pre-market tests for physical medical devices and do not involve AI/ML.

Therefore, I cannot fulfill your request for details on:

1. A table of acceptance criteria and reported device performance (for AI/ML): The document doesn't provide this for an AI/ML device. The performance tests are for mechanical properties and sterility.
2. Sample sizes used for the test set and data provenance: Not applicable in the context of AI/ML. The provided text refers to physical testing (e.g., fatigue tests, which would have sample sizes for individual abutments).
3. Number of experts used to establish ground truth and qualifications: Not applicable, as there's no AI/ML model requiring ground truth from experts. The software mentioned (Sirona CEREC Software) is a CAD/CAM design software, not an AI diagnostic tool.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not done, as there's no AI component for human readers to interact with.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of relevant information from the document (not AI/ML related):

• Device Type: Endosseous Dental Implant Abutment (physical component)
• Performance Tests Mentioned:
  • Dynamic fatigue and static strength tests (according to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments").
  • Biocompatibility (stated that materials are identical to predicate, so no new issues).
  • Sterilization process validation (according to FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1, ISO 17665-2).
• Conclusion of Performance Testing: "demonstrated that the Straumann Variobase C abutments are equivalent to the predicate and reference devices." This implies the device meets the performance characteristics of previously cleared similar devices.

In conclusion, the provided FDA 510(k) summary document pertains to a physical dental implant abutment and does not contain information about an AI/ML medical device or its acceptance criteria and study proving its performance.

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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.

BLX Variobase abutments are two-piece abutments composed of the following components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping or crown), Basal Screw. The BLX Variobase abutments 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. The BLX Variobase Abutments are manufactured from TAN (titanium-aluminum-niobium alloy) and are available in different gingiva heights and diameters. The abutments are delivered with the corresponding basal screw. The prosthetic restoration (copings/crowns) can be cemented onto the Variobase abutment and then the set is screwed on the implant using the basal screw. The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment). The BLX Variobase abutments are cleared under K173961. The purpose of this premarket notification is to extend the Straumann BLX Implant System portfolio with additional materials for customized restorations (upper part of the two-piece abutment) for use with the BLX Variobase abutments (lower part of the twopiece abutment).

Here's a breakdown of the acceptance criteria and the study information for the Straumann® BLX Variobase Abutment, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state sample sizes for specific 'test sets' in the way one might expect for a clinical trial or AI model evaluation. However, for the bench testing:

• Dynamic Fatigue Test: The text implies a sufficient number of samples were tested to demonstrate equivalence according to ISO 14801 and the FDA guidance. No specific number is given.
• Data Provenance: The studies were conducted as part of the device manufacturer's (Institut Straumann AG) regulatory submission to the FDA, suggesting a controlled internal testing environment. The country of origin for the data is implied to be related to the manufacturer's R&D facilities. This is a prospective set of tests conducted to support the 510(k) submission.

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

This information is not applicable to this type of device submission. The Straumann® BLX Variobase Abutment is a medical device, and its acceptance criteria are based on engineering performance specifications, material science, and regulatory compliance (e.g., sterilization efficacy, biocompatibility, mechanical strength), not on interpretation of images or patient data by experts. Therefore, "ground truth" in the clinical sense (e.g., diagnosis by radiologists) is not relevant here.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation involves bench testing and adherence to standards, not human adjudication of a clinical outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is an endosseous dental implant abutment, which is a prosthetic component.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. This device is a physical medical component, not an algorithm. Bench tests evaluate the standalone performance of the physical device under simulated conditions.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through:

• Established Standards: Adherence to international standards like ISO 14801 (dynamic loading) and ISO 10993-1 (biocompatibility), and ISO 17655-1 (sterilization).
• Regulatory Guidance: Compliance with specific FDA guidance documents for root-form endosseous dental implants and abutments.
• Material Specifications: Properties of the materials used (Ti-6Al-7Nb) meet established strength and biocompatibility profiles.
• Functional Equivalence: Demonstration that the new device performs equivalently to previously cleared predicate devices under defined test conditions.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device. It is a physical product, not an AI model requiring data training.

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

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

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The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.

The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.

CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained 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 Straumann PURE Ceramic Implant is a dental implant made out of yttrium-stabilized zirconium dioxide (Y-TZP). The Straumann PURE Ceramic Implant is based on features of the Straumann PURE Ceramic implant Monotype. Straumann PURE Ceramic Implants can be placed using the existing instruments using the same osteotomy preparation protocol as for Bone Level implants. The subject implant is a two -piece implant and is available in Ø4.1 mm with lengths of 8, 10, 12, and 14 mm.

The Closure and Healing caps are screws machined as one piece and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is titanium grade 4. 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 submerged (submucosal) healing protocols and do not support a prosthetic restoration. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.

The Temporary Abutments are used to serve as a temporary crown or bridge restoration for the Straumann PURE Ceramic Implant System.

The CI RD Straumann PUREbase Abutment for Ceramic implant is a premanufactured (stock) abutment (the first piece of the two-piece abutment), sometimes referred to as "Tibase", and is used as a base when fabricating a CAD/CAM customized restoration (the second piece of the two-piece abutment). The assembly of the two-pieces becomes a finished medical device after cementation of the CAD/CAM customized restoration on the PURE base abutment.

The Straumann PURE Ceramic Implant System did not present specific, quantified acceptance criteria with corresponding performance data in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate and reference devices through various tests.

However, based on the provided "Performance Data 5.7" section and the comparison tables, we can infer the types of acceptance criteria and the nature of the study that proves the device meets those criteria. The acceptance criteria generally revolve around demonstrating equivalence to legally marketed predicate and reference devices in terms of safety and effectiveness, as per FDA guidelines for 510(k) submissions.

Here's an attempt to structure the information based on the request, interpreting "acceptance criteria" as the performance standards expected for demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria were not stated, this table describes the type of performance evaluated and the outcome in relation to the predicate/reference devices.

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

The document describes bench testing for mechanical performance, biocompatibility, and sterilization. It does not refer to a "test set" in the context of clinical data or data from human subjects.

• Sample Size: Not explicitly stated for each test, but typically, mechanical and sterilization validations involve a statistically representative number of units or replicates to demonstrate consistency and meet statistical confidence levels defined in the relevant ISO standards (e.g., ISO 11135, ISO 14801). Biocompatibility is based on material composition equivalency, not a specific sample size.
• Data Provenance: The studies are described as bench tests (laboratory studies), biocompatibility assessments based on material equivalency, and sterilization/reprocessing validations. There is no mention of country of origin of data in the context of test subjects, as these are not human studies for this specific assessment. The data is generated from laboratory testing and analytical comparisons.

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

This information is typically relevant for studies involving human interpretation (e.g., image analysis by radiologists). For this device, which involves material properties and mechanical performance, the "ground truth" is established by adherence to international standards (ISO) and FDA guidance documents, and the expertise lies in the validation engineers and materials scientists performing and interpreting these tests. There is no mention of "experts" in the sense of clinical adjudicators for a "test set" in the provided text.

4. Adjudication Method for the Test Set

Not applicable as this is not a study involving human interpretation of medical data (e.g., images) requiring adjudication of findings. Performance is evaluated against objective engineering and scientific standards.

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

Not applicable. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This device is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations (mechanical, sterilization, biocompatibility) is defined by the International Organization for Standardization (ISO) standards and FDA guidance documents to which these tests were conducted.

• Biocompatibility: ISO 10993-1:2009.
• Sterilization: ISO 11135 and FDA Guidance on "Submission and Review of Sterility Information...".
• Reprocessing: ISO 17665-1:2006 and FDA guidance "Reprocessing Medical Devices in Health Care Settings...".
• Mechanical Testing (Dynamic Fatigue): ISO 14801:2016 and FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
• Wear and Screw Loosening: Bench tests demonstrating comparable behavior to reference devices, supported by a literature review for screw loosening risk.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model that requires a training set.

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

Not applicable. This device is not an AI/machine learning model.

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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 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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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.

The Medentika TiBases 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 TiBases are provided in several models and dimensions, according to the compatible implant systems declared in the Indications for Use statement.

The design of the CAD/CAM restorations is to be carried out through the Straumann CARES Visual Plug-In for Dental Wings CAD System. The patient-specific restorations must be milled by a Straumann milling center.

This document is a 510(k) submission for the Medentika CAD/CAM TiBases, which are dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a de novo approval requiring extensive clinical studies with acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes for AI/ML devices. Therefore, much of the requested information regarding AI/ML specific studies (MRMC, standalone performance, ground truth establishment for training/test sets, expert qualifications, adjudication methods) is not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (dental implant abutments), the "acceptance criteria" are related to mechanical performance and biocompatibility, demonstrating that the new devices are as safe and effective as the predicate devices. The performance data presented are primarily comparative to predicate devices rather than against specific numerical thresholds in a table.

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

This document does not describe a "test set" in the context of an AI/ML device evaluating data. For mechanical testing, specific sample sizes are not provided in this summary, but would typically be defined by the relevant ISO standards (e.g., ISO 14801). The "data provenance" would be from laboratory testing performed on the physical devices.

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

Not applicable for this type of device submission. Dental implant abutments do not use expert-established ground truth in the same way an AI diagnostic algorithm would.

4. Adjudication Method for the Test Set

Not applicable.

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

No, this is not an AI/ML device, so an MRMC study is not relevant.

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

Not applicable, as this is a physical medical device (dental implant abutment), not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility and sterilization, the "ground truth" is established by adherence to international standards (ISO 10993-1, ISO 17665-1/2) and successful completion of the tests defined within those standards. For mechanical testing, the "ground truth" is the established performance of the predicate device under specified fatigue test conditions as per ISO 14801.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

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

Not applicable.

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