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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.

Device Description

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.

AI/ML Overview

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

Feature/Test	Acceptance Criteria	Reported Device Performance
Dynamic Fatigue Test (Straumann BLX Variobase with Zolid SHT and Zolid HT crowns)	Demonstrated equivalence to the primary predicate and reference devices according to FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".	The tests demonstrated that the Straumann BLX Variobase with Zolid SHT and Zolid HT crowns are equivalent to the primary predicate and reference devices.
Milling System Validation	Confirmation that dimensions of milled restoration were the same as the intended CAD design from CARES Visual.	Leveraged from K171649, confirming the dimensions of the milled restoration were the same as the intended CAD design from CARES Visual. (Subject devices were not considered a new worst case, so existing validation was referenced).
Simulated Use Validation	Confirmation of scan, design, and production capability of the subject devices in CARES Visual.	Leveraged from K171649, confirming the scan, design, and production capability of the subject devices in CARES Visual. (Subject devices were not considered a new worst case, so existing validation was referenced).
Sterilization Process Validation	Validation according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".	The sterilization process for the Straumann Variobase as recommended in the labeling was validated.

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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K Number

K171649

Device Name

Straumann CARES M-Series CAD/CAM System

Manufacturer

Institut Straumann AG

Date Cleared

2018-02-22

(262 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K120822,K133421,K152383,K063511,K151157,K150899,K142890,K170354,K150203,K111421

Intended Use

Device Description

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.

AI/ML Overview

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.

Feature / Acceptance Criteria	Reported Device Performance (Equivalence Discussion)
Indications for Use (Straumann CARES M-SERIES CAD/CAM System vs. SIRONA DENTAL CAD/CAM SYSTEM)	Equivalent: The basic indication of providing support for prostheses scanning, design, and fabrication is the same. Support for TiBase-borne restorations is the same. The subject device indications refer to fabrication of coping, crowns, and bridges, including mesostructures (top-half of two-piece abutment), which are the same as referenced in the primary predicate indications. The crowns and bridges of the subject device are considered equivalent to hybrid abutments. The subject device also supports the fabrication of implant-connected solid abutments. This implies its performance meets the predicate for all these restoration types.
Source of Input Files	Equivalent: Capabilities of the subject device (Intra-Oral Scanner, Bench-top Scanners) include the scope of capabilities for the predicate device (Bench-top scanners).
Bench Scanner Control	Equivalent
Implant Detection	Equivalent: Both use Scanbodies.
Design Environment	Equivalent: Both are Closed CAD Systems facilitating the design of restorations, but for devices from different companies. Performance is considered equivalent in terms of design functionality.
Restoration Types Supported	Equivalent: Capabilities of the subject device (Copings/Crowns for Variobase, Copings/Crowns/Bridges for Screw-Retained Abutments, Bridges/Bars for Variobase for Bridge/Bar, Solid TAN Abutments) include the scope of capabilities for the predicate device (Copings/Crowns for TiBase, Copings/Crowns for Camlog Titanium Base). Both allow design and fabrication of the mesostructure for two-piece abutments (standard coping or hybrid crown/bridge). The subject device also allows design and fabrication of a one-piece titanium abutment. The areas of the abutment available for design are equivalent.
Supported Hardware Devices	Equivalent: Capabilities of the subject device (Straumann Variobase Abutments, Straumann Screw-Retained Abutments, Solid abutments) include the scope of capabilities for the predicate device (Sirona Ti-bases, Camlog Titanium Base). The subject devices provide support for implant-connected abutments.
Supported Restorative Materials	Equivalent: ZrO2 Ceramic material with indications according to ISO 6872 Classification are equivalent. The ZrO2 materials for use with the Straumann CARES M-Series CAD/CAM System have been previously cleared by FDA. The TAN material is identical to material used in CARES TAN Abutments (K150899). Straumann n!ce Blocks for Amann Girrbach were previously cleared (K170420). The use of the Ivoclar IPS e.max CAD material with Variobase Abutments has been cleared (K142890). The use of the n!ce material with Variobase Abutments has been cleared (K170354). This implies the milling performance and material properties for these materials meet prior predicate standards.
Restoration Sizes	Equivalent: Capabilities of the subject device (Single crown up to 16-Unit bridge) include the scope of capabilities for the predicate device (Single crown). Support of bridges through two or more implants is achieved through Variobase for Bridge/Bar abutments (K151157). Use of multiple implants in the bridge limit the force on the individual implant to be less or equivalent to that of the single crown. For a 16-unit bridge, the force is spread over 4 or more implants.
Interface to Ti-Base	Equivalent: The ability of the subject device to use solid blocks provides greater design flexibility to the user (compared to predicate's pre-milled blocks).
CAD to CAM Transfer	Equivalent: Seamless, same software interface.
CAM Capability	Equivalent: Capabilities of the subject device (Nesting, selection of tools/paths/speeds/feed rates, encryption) include the scope of capabilities for the predicate device (selection of tools/paths/speeds/feed rates).
CAM to Mill Transfer	Equivalent: Capabilities of the subject device (encrypted file format ensuring only Straumann CARES Visual and CAM Module files are accepted) include or exceed the scope of capabilities for the predicate device (expected transfer encryption).
Supported Mills	Equivalent: Capabilities of the subject device (Straumann CARES M-Series Mills) include the scope of capabilities for the predicate device (CEREC MCXL Mill, inLab MCXL Mill).
Fabrication Workflow	Equivalent: Capabilities of the subject device (Dry milling of partially crystallized ceramic, Wet milling of Ti-6Al-7Nb Pre-Milled Abutment Blanks, Ivoclar IPS e.max CAD, and n!ce Glass Ceramic) include the scope of capabilities for the predicate device (In-lab wet milling of pre-sintered ceramic blocks).
Variobase Abutments: Indications for Use	Identical to predicate Straumann Variobase Abutments (K142890, K120822).
Variobase Abutments: Ti-base Material	Identical: Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb).
Variobase Abutments: Abutment Diameter	Identical: 3.8 – 7.0 mm.
Variobase Abutments: Abutment Height	Identical: 3.5 – 4.5 mm.
Variobase Abutments: Coping/Crown Material	Equivalent/Identical: Digital workflow is expanded to add additional materials (Ceramill ZOLID series, Ivoclar IPS e.max CAD, Straumann n!ce). The Zi, ZOLID series are equivalent to predicate's zerion ZrO2 material. Use of n!ce and IPS e.max CAD is identical to previously cleared devices.
Variobase Abutments: Design Workflow	Equivalent: Subject employs a subset of predicate's techniques (CAD vs. Wax-up or CAD).
Variobase Abutments: Fabrication Workflow	Equivalent: Restorations milled by the dental laboratory are equivalent to those produced by the Straumann milling center.
Variobase Abutments: Mode of Attachment	Identical: Screw-retained or cement retained.
Variobase Abutments: Reusable	Identical: No.
Laboratory Milled CARES® TAN Abutments: Indications for Use	Identical to predicate Straumann® CARES® TAN Abutments (K150899).
Laboratory Milled CARES® TAN Abutments: Abutment Material	Identical: Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb, TAN).
Laboratory Milled CARES® TAN Abutments: Abutment Apical Design	Identical: Engaging, BoneLevel (NC, RC), Tissue Level (RN, WN).
Laboratory Milled CARES® TAN Abutments: Abutment Coronal Design	Identical: CADCAM design process, designs controlled by material-specific design limits in CARES Visual CAD software, model verification by CAM software, and milling blank dimensions.
Laboratory Milled CARES® TAN Abutments: CAD Design Limits	Identical: Max. Angulation 30°, Emergence Offset 0.1 mm, Emergence Angle 65°, Min. Thickness 0.4 mm, Smooth Distance 0.5 mm, Min post surface area 37 to 56mm².
Laboratory Milled CARES® TAN Abutments: Fabrication Method	Equivalent: Both methods use Straumann CARES Visual CAD software for design, applying the same validated limits. The difference is the manufacturing location (QSR controlled vs. dental laboratory). The milling accuracy of the Straumann CARES M-Series CAD/CAM System has been validated. Labeling has been revised and validated for milling unit installation, maintenance, and required tools/machine liquids/material blocks to ensure equivalence.
Laboratory Milled CARES® TAN Abutments: Directly Veneerable?	Identical: Yes.

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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