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The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

The Straumann Custom Abutments (previously named Straumann CARES Abutments) are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. The Custom Abutments are patient-matched abutments; the customer scans the intraoral situation and designs the shape using a Straumann-approved CAD/CAM software (such as Straumann CARES Visual). The design data is then transferred to Straumann where the fabrication of the custom abutment is carried out at a Straumann validated milling center (FEI: 3024185724 or FEI: 3011221537). The existing Custom Abutments feature a straight screw channel for the basal screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments with an angled screw channel to the Straumann Custom Abutment Portfolio. The subject Custom Abutments can be designed and manufactured with an angled screw channel (as opposed to straight), so that the screwexit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angled, the screwdriver maximum angle is 20°.

The Custom Abutments are designed for connection to implants of the Straumann Dental Implant System. The Custom Abutments have an implant-specific connection interface for the respective compatible implant. The Custom Abutments with the SynOcta geometry (RN or WN) are designed for connection to the Straumann Tissue Level (TL) implants. Those with the CrossFit geometry (NC or RC) are designed for connection to the Bone Level (BL) and Bone Level Tapered (BLT) implants. The Custom Abutments with the TorcFit geometry, are designed for connection to the Straumann Bone Level BLX and BLC (RB/WB or WB) or Tissue Level TLX and TLC (NT, RT, WT) implants. The basal screws feature threads to secure the abutment with the implant inner geometry. The basal screws also contain the connection geometry to mate with the AS screwdrivers for installation into the implant.

The provided text is a 510(k) Summary for "Custom Abutments" and details the substantial equivalence of the device to legally marketed predicate devices. It does not contain information on an AI/ML-driven device or study results proving a device meets acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, FROC, etc.).

The document describes a dental implant abutment designed for customized patient use, with a key modification being the addition of an angled screw channel. The non-clinical testing sections focus on mechanical fatigue testing, digital workflow validation, sterilization, MRI compatibility, and biocompatibility, as is typical for a medical device of this type.

Therefore, I cannot fulfill your request for information on acceptance criteria and study proving device meets acceptance criteria for an AI/ML device, as the provided text pertains to a traditional medical device (dental abutments) and does not mention any AI/ML component.

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Patient-specific abutment restorations, milled from Pre-milled Abutment Blanks (PMABs), are indicated for single tooth replacement and multiple tooth restorations. They are directly connected to various endosseous dental implant systems using a basal screw. Patient-specific abutment restorations milled from Pre-milled Abutment Blanks are to be digitally designed and milled using the Straumann InLab Validated Workflow. The Straumann InLab Validated Workflow 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, pre-milled abutment blanks, milling machines and associated tooling and accessories.

The Straumann InLab Validated Workflow is similar to the primary predicate K171649. It employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The 3Shape 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. When choosing the Straumann Validated workflow, the user will only see the available and cleared components which were tested and demonstrated as part of the validated workflow. The milling command file is encrypted prior to transfer to the Roland DWX-42W Plus milling System; this encryption ensures that files generated using other CAD or CAM software cannot be used with the Straumann InLab Validated Workflow. The user will then load the milling command file into the Roland DWX-42W Plus milling System where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.

This premarket notification includes restorations (one-piece metal patient-specific abutment restorations) manufactured from various Pre-milled Abutment Blanks (PMABs) from the Straumann Group companies : Institut Straumann AG and Neodent PMABs. The digital workflow using the Straumann InLab Validated Workflow includes the use of the following products: Dental Scan of the patient's situation, CAD Software, CAM Module, Milling System, Abutment Milling Blanks.

The provided text is a 510(k) Summary for the Straumann InLab Validated Workflow, a device for designing and manufacturing patient-specific dental abutments from pre-milled abutment blanks (PMABs). The document describes the device, its intended use, technological characteristics, and performance testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in a consolidated format as typically seen in a clinical study report. However, it mentions key performance areas and states that requirements were met.

Acceptance Criteria (Implicit from tests performed):

• Sterilization Validation: Meet ISO 17665-1 and FDA guidance for reprocessing medical devices.
• Biocompatibility: In line with ISO 10993-1 and FDA guidance for biological evaluation.
• Electromagnetic Compatibility (EMC): Considered MR Conditional.
• Milling Accuracy: Dimensions of milled restoration are the same as the intended CAD design, met within tool's expected lifetime.
• Simulated Use Validation: Correct implementation of PMABs, design constraints, and workflow restrictions in software and libraries.
• Implant-Abutment Connection Protection: No damage to the connection geometry during milling.
• Dynamic Fatigue: Performance consistent with FDA guidance for dental implants/abutments.

Reported Device Performance:

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

The document does not specify the exact sample sizes used for the test sets in the performance studies (e.g., dynamic fatigue, milling accuracy, simulated use validation). It refers to these as "Performance Testing - Bench."

Data Provenance: The studies are described as "nonclinical tests" and "bench" testing, suggesting they were conducted in a laboratory or simulated environment, rather than involving patient data. The document does not specify country of origin for the data (beyond the applicant being Institut Straumann AG in Switzerland and JJGC Indústria e Comércio de Materiais Dentários AS in Brazil, with contact in Andover, MA, USA). The studies appear to be prospective, designed specifically for this submission.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation methods described (e.g., milling accuracy, simulated use) imply technical verification against design specifications and functional requirements rather than expert consensus on diagnostic or clinical outcomes.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as there is no indication of multiple reviewers or subjective assessments requiring adjudication in the described bench tests.

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

No MRMC comparative effectiveness study is mentioned. The device is a workflow for manufacturing dental restorations, not an AI diagnostic or assistive tool for human readers in the traditional sense of comparing human performance with and without AI assistance for interpretation.

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

The milling accuracy test ("black-box validation confirming that the dimensions of the milled restoration are the same as the intended CAD design") and the simulated use validation implicitly test the algorithm and workflow in a standalone manner, separate from a human operator's interpretative judgment. The "Straumann InLab Validated Workflow" itself is largely an automated process once the design is finalized. It is designed to ensure that the digital design translates accurately into a physical product.

7. Type of Ground Truth Used

The ground truth used for these performance tests appears to be:

• Design Intent/Specifications: For milling accuracy, the ground truth is the CAD design itself. For simulated use, the ground truth refers to the correct implementation of design constraints and workflow restrictions within the software and libraries.
• Industry Standards and Regulatory Guidance: For sterilization, biocompatibility, and dynamic fatigue, the ground truth is defined by recognized international standards (ISO) and FDA guidance documents.
• Functional Requirements: For implant-abutment connection protection, the ground truth is the prevention of damage to the connection geometry.

8. Sample Size for the Training Set

The document does not describe the use of machine learning or AI models in a way that would involve a distinct "training set" in the context of typical software or diagnostic AI submissions. The workflow involves CAD/CAM software where parameters and constraints are defined by engineering and design principles rather than learned from a large training dataset.

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

As no specific training set for a machine learning model is described, there is no information on how its ground truth would have been established. The workflow relies on validated engineering designs, material properties, and manufacturing processes.

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Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

The Straumann Anatomic Healing Abutments XC (referred to as the AHAs) are intended for use with the Straumann Dental Implant System (SDIS). The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the osseointegration phase of Straumann endosseous dental implants to be rehabilitated using the delayed loading technique. The AHA are to be used during the implant placement surgery or in the reopening surgery (second surgical phase) and are for temporary use up to 180 days. The AHAs are to be placed out of occlusion. The healing abutments do not support a prosthetic restoration.

The AHAs are composed of two united parts: a body that allows for customization and includes a through hole for fixation screw access, and a basal screw that cannot be altered. The Anatomic Healing Abutments are intended to be customized using only hand milling instruments manually controlled by dental professionals. To protect the consistent emergence profile for final abutment, a maximum 3mm height can be modified down to the occlusal surface. To preserve the scanning function of AHA, a 4.7mm circular area around the central axis of the screw channel cannot be modified. The body is milled from polyetheretherketone (PEEK Classix). The basal screws are existing basal screws manufactured from Titanium-Aluminum-Niobium (TAN) alloy previously cleared as part of the Straumann BLX system in K173961.

The AHA are designed for connection to BLC and BLX implants of the Straumann Dental Implant System (K173961, K181703, K191256, K210855, K212533, K230108, and K234049). The AHA are available in diameters of Ø3.8 mm, 4.5mm, 5.5mm, and 6.5mm. They are available in 4 shapes designed according to specific areas of the dentition including S, S1, M, and XL, however, they are not limited to use exclusively in these positions. The AHA are offered in regular base (RB) and wide base (WB) configurations consistent with the Straumann BLX and BLC prosthetic platform offerings.

The AHAs may also be used in intraoral scanning procedures of single-unit restorations to represent the position, axis, and orientation of the dental implant placed in the patient's jaw relative to the surrounding dentition. A scanbody feature extends from the occlusal surface of the AHA.

The provided text is a 510(k) summary for the Straumann Anatomic Healing Abutments XC (AHA). It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain the detailed acceptance criteria or a study designed to prove the device meets specific performance criteria in the format typically used for AI/software-based medical devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices through comparisons of technological characteristics, intended use, and various performance tests (sterilization, shelf life, biocompatibility, torque, and basic software verification) that confirm the new device functions as expected for a medical device of its class, rather than proving specific numerical performance metrics against defined acceptance criteria in a clinical setting.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here is what can be extracted and inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantifiable acceptance criteria with corresponding performance results are not provided in the document for the device itself (Straumann® Anatomic Healing Abutments XC). The document focuses on demonstrating substantial equivalence to predicate devices through various tests rather than meeting numerical performance thresholds for image analysis or diagnostic accuracy.

The performance tests mentioned are:

• Sterilization Validation and Shelf Life:
  • Acceptance Criteria (inferred): Sterility Assurance Level (SAL) of 10^-6 for gamma irradiation and successful steam sterilization validation. Packaging stability for a 5-year shelf life.
  • Reported Performance: Met SAL of 10^-6 using VDmax25 in accordance with ISO 11137-1:2006. Steam sterilization validation met all test method acceptance criteria. Packaging stability for the 5-year shelf life of predicate devices was adopted.
• Pyrogen Testing (LAL test):
  • Acceptance Criteria (inferred): Pyrogen limit specification of 20 endotoxin units (EU)/device.
  • Reported Performance: Met the specified limit.
• Biocompatibility Testing:
  • Acceptance Criteria (inferred): No cytotoxic reaction, no extractable substances above Analytical Evaluation Threshold (AET).
  • Reported Performance: No cytotoxic reaction detected. No extractable substances detected above AET.
• Performance Testing - Bench (Torque Testing):
  • Acceptance Criteria (inferred): Withstands repeated insertion and removal torques without damage.
  • Reported Performance: Performed, demonstrating the AHA withstands repeated insertion and removal torques without damage. (Specific numerical thresholds not provided).
• Software Testing (Scan Verification and Integration):
  • Acceptance Criteria (inferred): Can be scanned with an intraoral scanner and is suitable to work with CARES Visual software.
  • Reported Performance: Performed, demonstrating the subject AHAs can be scanned with an intraoral scanner and are suitable to work with CARES Visual software. (No specific metrics provided).

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

• The document describes engineering tests (sterilization validation, mechanical torque testing, biocompatibility, software verification) rather than a clinical study with a "test set" of patient data. Therefore, this information is not applicable in the context of this 510(k) for a physical device.

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

• Not applicable as this is not a study involving expert-derived ground truth on a clinical dataset for AI/software performance.

4. Adjudication method 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. This is a physical medical device (healing abutment), not an AI/software for diagnostic assistance.

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)

• For the engineering tests:
  • Sterilization/Pyrogenicity: Laboratory test results against validated standards and specified limits.
  • Biocompatibility: Laboratory test results against ISO standards and AET.
  • Torque Testing: Mechanical testing results against functional requirements (withstanding torque without damage).
  • Software Testing: Functional verification (can be scanned, works with software).

8. The sample size for the training set

• Not applicable, as this is a physical device and not an AI/ML model that requires a "training set."

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

• Not applicable.

Summary of what the document implies about meeting criteria:

The document asserts that the Straumann® Anatomic Healing Abutments XC (AHA) meet the necessary performance criteria through a series of benchtop engineering tests and validations designed to demonstrate:

• Effective sterilization (gamma irradiation and steam sterilization).
• Pyrogenicity within acceptable limits.
• Biocompatibility of the materials.
• Mechanical integrity (torque resistance).
• Compatibility with intraoral scanning and associated software.

The primary "study" presented is a comparison to predicate devices to establish substantial equivalence based on similar technological characteristics and performance testing. The "acceptance criteria" are implicitly met by successful completion of these validation tests against established industry standards (e.g., ISO) and functional requirements, rather than through a clinical study with statistical performance metrics against a defined ground truth.

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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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Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

The subject devices are part of the BLX implant line, a fully tapered implant manufactured out of Roxolid and having the SLActive or SLA surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø5.0mm and lengths of 18 mm and diameters of Ø5.5mm and Ø6.5mm and lengths of 14 mm and 16 mm. The subject devices are presented with the WB (Wide Base) prosthetic platform. The internal connection and the prosthetic platform are identical for all subject devices.

This document, a 510(k) summary for the BLX WB dental implants, does not contain the specific information requested about acceptance criteria and the study proving the device meets them in the format of AI/ML device performance. This is because the device described is a traditional medical device (dental implants), not a software as a medical device (SaMD) or an AI/ML-driven diagnostic tool.

Therefore, there is no discussion of:

• A table of acceptance criteria and reported device performance related to AI/ML metrics.
• Sample size used for test set or data provenance in the context of algorithm evaluation.
• Number and qualifications of experts for establishing ground truth for a test set.
• Adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data in the context of AI/ML).
• Sample size for training set or how ground truth was established for a training set.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is shown by comparing indications for use, technological characteristics (materials, surface treatment, connection, dimensions, design), and performance testing.
• Performance Bench Testing:
  • Dynamic fatigue testing: Conducted according to FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments). The testing was leveraged from a reference device (K173961), indicating that the new device does not introduce a new worst-case scenario. This implies the acceptance criteria for fatigue are met by demonstrating equivalence to a device that already meets them.
  • Insertion tests: Performed for the subject implants, showing "adequate insertion torque in different bone classes" and results "equivalent to the primary predicate device." This implicitly sets acceptance criteria as "adequate" and "equivalent to predicate."
• Biocompatibility Testing: Assessed according to ISO 10993-1:2009 and FDA guidance. The conclusion is that "No new issues of biocompatibility are raised for the subject devices," meaning existing biocompatibility standards for similar devices are met.
• Sterilization Validation and Packaging:
  • Validated to a sterility assurance level (SAL) of 10-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2013.
  • Shelf life: 5 years (identical to predicate).
  • Pyrogenicity: Met limit specifications (20 EU/device) via LAL Endotoxin Analysis.

In summary, the "acceptance criteria" for this traditional medical device are largely defined by equivalence to predicate devices and adherence to recognized international standards (ISO) and FDA guidance documents for mechanical performance, biocompatibility, and sterilization. The "study that proves the device meets the acceptance criteria" refers to the bench testing and validation efforts described above, not to clinical trials or AI/ML performance studies.

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The Straumann CARES P-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, a restorative acrylic resin, 3D printers, post-curing unit and associated accessories. The system is used to design and fabricate CAD/CAM 3D printed coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments that are affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

The Straumann P pro Crown & Bridge material in combination with the Straumann Variobase is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.

The Straumann CARES P-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow for 3D printing.

The Straumann CARES P-Series CAD/CAM System employs optical impression files that document the topoqraphical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the desired restorations. The CAM software converts the digital restoration design into the sequential slice geometries needed to 3D print a restoration or multiple restorations in a print job. The printing file is transferred to the Straumann P-Series 3D printer; where it is decoded into the defined printing slices and the user initiates the printing operation. The Straumann P-Series 3D printer will then print the designed restoration using the Straumann P Pro Crown & Bridge resin.

The user of a Straumann CARES P-Series CAD/CAM System can design dental implant borne restorations using Straumann Variobases as the connecting interface to the implant. By this, the user will create two-piece abutments with the 3D printed part being the upper part of the implant borne restoration.

The provided text is a 510(k) summary for the Straumann CARES P-Series CAD/CAM System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the manner of a clinical trial or performance study comparing a new algorithm's efficacy.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/algorithm-based device is not explicitly available in this document. The device in question is a CAD/CAM system for designing and fabricating dental restorations, not an AI diagnostic tool.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for a specific performance metric in the context of an AI algorithm. Instead, it describes "Design Specifications" which serve as internal parameters for the CAD/CAM system and performance testing related to mechanical properties.

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

This information is not provided in the document. The testing described primarily involves mechanical material testing and software verification, not clinical or diagnostic data analysis. Therefore, concepts like "test set" in the context of an AI algorithm are not applicable here.

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

This information is not applicable as the document describes a CAD/CAM system for fabricating dental prosthetics, not a diagnostic AI algorithm requiring expert ground truth for imaging or clinical decision support. The "ground truth" for the mechanical characteristics would be established by standardized testing protocols.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as in point 3.

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

This information is not applicable. The device is a CAD/CAM system for fabrication, not an AI for human reader assistance or diagnostic interpretation.

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

The "standalone" performance described relates to the verification of the 3D printer system and the CAD software.

• Software Verification and Validation: This was performed to demonstrate that the software's restrictions prevent designing components outside allowable limitations and that the design library is locked. This implies a standalone verification of the software's adherence to design rules.
• 3D Printer System Verification: This confirmed that "the design input matched the output, that the process is repeatable and independent of print orientation, build plate location effects, and the effects of material reuse." This is a form of standalone performance assessment for the manufacturing component.

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

The "ground truth" for the performance testing cited appears to be:

• Standardized Mechanical Testing: According to FDA guidance for dental implants and abutments. This involves objective measurements of strength and fatigue.
• Material Specifications: Biocompatibility data from a previously cleared 510(k) for the P pro Crown & Bridge material (K200039).
• Design Specifications: Defined parameters (e.g., minimum wall thickness, maximum angulation) that the CAD software must adhere to.

This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI diagnostic systems.

8. The sample size for the training set

This information is not provided and is not applicable as the device is not an AI/machine learning algorithm requiring a "training set" in the conventional sense.

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

This information is not provided and is not applicable for the same reasons as in point 8.

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The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

The Straumann CARES M-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow. The workflow is unchanged from the primary predicate K171649. This premarket notification is introducing the Straumann Variobase Abutments for the BLX implant to abutment interface to the previously cleared workflow.

The Straumann CARES M-Series CAD/CAM System employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the design of the desired restorations. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.

This premarket notification includes restorations (copings, and bridges) manufactured from Zolid HT/Zolid SHT materials for cementation on Straumann Variobase Abutments for the BLX implant system. The BLX dental implant platforms include RB (Regular Base) and RB/WB (Regular Base/Wide Base). The combination of the coping, crown, or bridge and the Variobase Abutment component make up a two-piece abutment assembly, which is used in conjunction with endosseous dental implants for single or multiple tooth dental prostheses.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Specific sample sizes for the test set of the dynamic fatigue tests, milling system validation, and simulated use validation are not explicitly stated in the provided document.

The document mentions that the studies were "leveraged from K171649" (the primary predicate device) and that "the subject devices were not considered a new worst case." This implies that the validation data was likely historical or previously collected for the predicate device.

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective or Prospective: Not explicitly stated, but "leveraged from K171649" suggests a retrospective application of existing data and validation reports.

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

This information is not provided in the document. The studies mentioned are primarily engineering and performance tests (dynamic fatigue, dimensional accuracy, sterilization efficacy) and do not involve human expert interpretation of device output in a diagnostic or clinical context to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are performance and engineering validations, not studies involving human interpretation or clinical adjudication.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned in the document. The device described is a CAD/CAM system for fabricating dental prosthetics, which is a manufacturing process, not an AI-powered diagnostic or interpretive tool that would typically be evaluated with MRMC studies.

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

The "Milling System Validation" and "Simulated Use Validation" could be considered forms of standalone performance evaluation for the CAD/CAM system's components (software outputs, milling accuracy).

• Milling System Validation: Confirmed "the dimensions of the milled restoration were the same as the intended CAD design from CARES Visual." This evaluates the algorithm's (CAD/CAM software's) ability to translate digital design into physical form, without human intervention in the final output quality check for the purpose of this specific validation.
• Simulated Use Validation: Confirmed "the scan, design, and production capability of the subject devices in CARES Visual." This also assesses the system's performance in a simulated workflow.

The dynamic fatigue tests evaluate the physical product, not directly the algorithm's performance.

7. The Type of Ground Truth Used

• Dynamic Fatigue Test: Ground truth is established by the specified FDA guidance document regarding performance requirements for dental implants and abutments. This involves objective physical testing against performance standards.
• Milling System Validation: The "intended CAD design from CARES Visual" serves as the ground truth against which the milled restoration is compared for dimensional accuracy.
• Simulated Use Validation: The expected functional capability of the system (scan, design, production) serves as the ground truth.
• Sterilization Process Validation: The ground truth is adherence to the validated sterilization parameters and expected sterility assurance levels as defined by the FDA guidance document.

8. The Sample Size for the Training Set

This information is not provided in the document. The device is a CAD/CAM system, and while CAD/CAM software development might involve training (e.g., machine learning for design optimization or material properties), the submission focuses on validating the manufacturing process and the final product's performance, not the training of an AI model in the typical sense. The "training set" for the CAD/CAM system would implicitly be the engineering data and design principles embedded in the software.

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

As above, this information is not provided. If there were any AI/ML components in the CAD/CAM software that involved "training," the method for establishing ground truth for that training is not discussed. For the broader CAD/CAM system's engineering and design, the ground truth would typically be established through established engineering principles, material science, and preclinical testing to ensure precise and functional designs.

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The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.

The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.

The Straumann Immediate Temporary Abutment and associated Plastic Copinq consist of a titanium abutment and PMMA coping for the Straumann dental implants BL, BLT and BLX. The abutments are available in a variety of gingival heights and diameters to fit individual patient situations. The PMMA coping is compatible with the subject Immediate Temporary Abutments. The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. 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 for up to 180 days.

The provided text is a 510(k) summary for the Straumann® Immediate Temporary Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative performance study context.

Therefore, many of the requested sections about acceptance criteria, specific reported device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance studies are not explicitly detailed in the provided text, as these are typically part of a different type of submission (e.g., a PMA or scientific publication).

However, I can extract information related to the functional characteristics and the types of testing performed to support the substantial equivalence.

Here's an attempt to answer your request based on the provided text, highlighting what is available and what is not:

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

The document does not explicitly state quantitative acceptance criteria or reported device performance in the format of a performance study with specific metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating equivalence to predicate devices through various tests.

The "acceptance criteria" here are implicitly meeting the standards of the predicate devices and relevant ISO standards. The "reported device performance" is a statement that these standards and equivalence have been met.

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

The document does not provide details on specific sample sizes for test sets used in the various performance tests (biocompatibility, sterilization, disinfection, or implied mechanical testing). The data provenance is not mentioned (e.g., country of origin, retrospective/prospective). These types of details are usually found in the full test reports, not typically in the 510(k) summary.

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 is not applicable to the type of device and testing described. The "ground truth" for this medical device (dental abutment) is established through adherence to engineering standards, material science, and biological safety guidelines, rather than expert clinical interpretation of data (like in imaging diagnostics).

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

Not applicable. This is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for the physical and biological testing of a dental abutment.

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. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiologists, pathologists) often assisted by AI. This device is a physical dental abutment.

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

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

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

The "ground truth" for this device is based on established engineering and material science standards (e.g., ISO for biocompatibility and sterilization), and the performance characteristics of predicate devices. For instance, the biocompatibility testing assesses the device against accepted safety limits for biological responses.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

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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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TLX Novaloc Abutments: The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants (NT, RT, and WT).
TLX Cementable Abutments: Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Final abutments may be placed into occlusion for implants with sufficient primary stability and with appropriate occlusal loading to restore chewing function or for implants that are fully osseointegrated.

Straumann TLX Novaloc Abutments: The subject TLX Novaloc Abutments are intended to be placed onto Straumann TLX implants to provide support for full arch detachable restorations (over-denture). The coronal portion of the subject abutments is similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann TLX Implant System (NT, RT and WT). The Novaloc Abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc Abutment through a snap-on fixture provided by a negative shape of Novaloc snapon fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject TLX Novaloc Abutments are provided in straight and angulated versions, in different heights. The TLX Novaloc Abutments are provided non-sterile with instructions for end user sterilization.
Straumann TLX Cementable Abutments: The subject TLX Cementable Abutments are intended to provide support for prosthetic reconstructions such as crowns and bridges and are used with cemented restorations. They are made of titanium alloy (Ti-6Al-7Nb or TAN) and are attached to the implant with a basal screw. To allow for more flexibility they are offered in a straight and in an angulated version for each of the three platforms (NT, RT and WT). The TLX Cementable Abutments are provided non-sterile with instructions for end user sterilization.

The provided text describes the regulatory clearance of a medical device (Straumann TLX Novaloc and Cementable Abutments) and includes a summary of performance testing. However, it does not contain the specific information required to complete numbers 2, 3, 4, 5, 6, 7, 8, and 9 of your request. These details are typically associated with clinical studies and AI performance evaluations, which are not the focus of this 510(k) summary.

Here's the information that can be extracted and a note on the missing information:

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

The acceptance criteria for this device are based on demonstrating equivalence to predicate devices through various performance tests. The specific numerical acceptance criteria (e.g., minimum breaking strength or fatigue cycles) are not explicitly stated as numerical values in this summary but are referenced against established standards and guidance documents.

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 510(k) summary. The testing described is bench testing, not a clinical study with human subjects, so concepts like "test set" in the context of clinical data are not applicable here.

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 provided as the submission focuses on bench testing for mechanical and biological equivalence, not expert-adjudicated clinical performance.

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

Not applicable, as this was bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental abutment, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a dental abutment, not an AI algorithm.

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

For mechanical and biocompatibility testing, the "ground truth" refers to established scientific principles, standards (ISO 14801, ISO 10993-1, ISO 17665-1, ISO 17665-2), and FDA guidance documents. There is no biological "ground truth" derived from patient outcomes or expert consensus in the context of this 510(k) summary.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model requiring a training set.

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

Not applicable.

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