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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 and K240982 to allow additional options of zirconia material, scanners, CAM software, and milling machines to the digital dentistry workflow. The subject devices are to be sent to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. There are no changes to the abutment design, implant compatibilities, or design parameters. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows (also referred to as point of care) under K221301 and K240982.

The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.

All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine and associated tooling and accessories.

The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The provided 510(k) summary for DESS Dental Smart Solutions focuses on demonstrating substantial equivalence to predicate devices for dental implant abutments. It primarily addresses the expansion of compatible materials, scanners, CAM software, and milling machines within an existing digital dentistry workflow. The document does not describe an AI/ML-based device that would typically have acceptance criteria related to diagnostic performance.

Therefore, many of the requested items related to AI/ML device performance (like acceptance criteria for diagnostic metrics, sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.

The acceptance criteria and supporting "study" (non-clinical data) for this device are related to its mechanical performance, biocompatibility, and integration within the digital workflow, demonstrating that the expanded components maintain the safety and effectiveness of the previously cleared predicate devices.

Here's a breakdown based on the information provided and the non-applicability of AI/ML-specific questions:

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

Since this is not an AI/ML diagnostic device, the acceptance criteria are not in terms of traditional diagnostic metrics (sensitivity, specificity, AUC). Instead, they are related to material properties, mechanical integrity, and the digital workflow's accuracy.

• Abutment design library validated to demonstrate established design limitations are locked and cannot be modified by the user. (Implies successful implementation and verification of design constraints.) |
  | CAM Restriction Zones / Manufacturing Accuracy | - Validation testing of CAM restriction zones conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in CAM software. (Implies successful validation to ensure manufacturing precision and prevent damage.) |
  | Material Conformance | - Zirconia materials conform to ISO 6872.
• Titanium alloy conforms to ASTM F136.
• Co-Cr-Mo alloy conforms to ASTM F15337. (Implies materials meet standards.) |
  | Physical Dimensions | - Device encompasses the same range of physical dimensions as the predicate device. (Implies dimensional equivalence.) |

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

• Sample Size: Not explicitly stated in terms of a "test set" for diagnostic performance. The validation involved physical testing of components (e.g., fatigue testing) and software verification. The specific number of abutments or digital design instances used for these non-clinical tests is not detailed in this summary.
• Data Provenance: Not applicable in the context of patient data for an AI/ML device. The "data" here refers to engineering and material testing results, likely conducted in controlled lab environments (implied to be in accordance with international standards like ISO and ASTM). The manufacturer is Terrats Medical SL, in Spain, so testing would likely originate from their facilities or contracted labs.

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)

Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device relates to engineering specifications and material science.

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

Not applicable. This is not a diagnostic device involving expert review 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

Not applicable. This device is 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 is not an AI/ML algorithm.

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

For this device, the "ground truth" is based on:

• Engineering Specifications: Defined design parameters (e.g., minimum wall thickness, post height, angulation limits).
• Material Standards: Conformance to international standards such as ASTM F136, ISO 6872.
• Benchmarking/Predicate Equivalence: Performance is assessed against established performance of the predicate devices and OEM implant systems.
• Software Validation Logic: Verification that software correctly enforces design rules and CAD/CAM restrictions.

8. The sample size for the training set

Not applicable. This device does not involve a machine learning training set.

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

Not applicable. This device does not involve a machine learning training set.

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BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed abutments for use with Conical Ti Base abutments are to be sent to a BioHorizons validated milling center for manufacture or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The BioHorizons Conical Ti Base abutments are prosthetic components and are intended for the restoration of BioHorizons dental implants within the specific indications of each implant system. All Conical Ti Base abutments are two-piece titanium-base type abutments with a pre-manufactured titanium base component cemented to a zirconia superstructure to create the final finished dental abutment. All the titanium bases are manufactured from Ti-6Al-4V titanium alloy per ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications and are for single patient use. The prosthetics are provided non-sterile as indicated on the label. The subject devices are permanent or long-term, tissue/bone implant devices intended for more than 30 days of patient contact. BioHorizons dental prosthetics are invasive and / or surgically invasive devices placed in healed or compromised oral sites in direct contact with bone and soft tissue.

The Conical Ti-Base abutments are provided in engaging and non-engaging designs and are designed for single-unit or multi-unit restoration with a CAD/CAM zirconia superstructure attached to the abutment. The titanium base components are available for narrow and regular platforms and with gingival heights of 0.8 mm and 2.0 mm. The titanium base component post has been manufactured with matte finish creating a roughened surface to accommodate cementing. All patient-specific custom abutment fabrication for Conical Ti Base abutments are by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Conical Ti Base abutments are made at a BioHorizons validated milling center under FDA quality system regulations, as cleared in K240187, or according to a digital dentistry workflow (subject of this submission described in the section below). As cleared in K240187, zirconia material, sagemax NexxZr® zirconia (K130991) is used to fabricate the patient-specific zirconia superstructure or direct crown. The cement for bonding of superstructures or crowns is a dual cure cement, 3M™ RelyX™ Unicem 2 Automix (K022476). These cleared materials are identical to the proposed digital dentistry workflow. The pre-manufactured titanium base component are not to be modified and are only intended to permit a customized zirconia restoration.

The design and fabrication of the zirconia superstructure will be conducted using a digital dentistry workflow requiring the use of the following equipment:

• Scanner: 3Shape Trios 5 intra-oral scanner.
• Design Software: 3Shape Abutment Designer Software, K151455.
• Zirconia Material: sagemax® NexxZr zirconia, K130991.
• CAM software: hyperDENT® Classic
• Milling machine: imes-icore® CORiTEC 150i Pro milling machine
• Cement: 3M™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement, K022476.

The designed superstructure is attached to the titanium base component by the use of an FDA-cleared cement, 3M™ RelyX™Unicem 2 Automix Self-Adhesive Resin Cement, K022476. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient. The final abutment is equivalent to the final abutment cleared in K240187.

The provided document is an FDA 510(k) clearance letter for the Conical Ti Base abutments.

*Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about any clinical studies, sample sizes, expert ground truth establishment, or AI effectiveness studies.

The letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:

• Identical intended use: Both the subject device and the primary predicate (K240187) are "intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations." The subject device adds the "digital dentistry workflow" aspect, which is equivalent to the secondary predicate (K231307).
• Similar or identical design and technological characteristics: This includes material composition (Ti-6Al-4V alloy for the titanium base, sagemax NexxZr zirconia for the superstructure), manufacturing methods, digital design software and hardware (for the zirconia superstructure), design limitations, usage, sterility, and biocompatibility.

The "Performance Data" section discusses:

• Reliance on predicate submission data for non-clinical aspects like mechanical testing, biological safety, steam sterilization, and magnetic resonance testing, as there were no changes since the previous clearance (K240187).
• New testing was conducted to support the CAD/CAM design and use within a digital dentistry workflow, demonstrating controls of this workflow and that the final abutment is equivalent to those produced by the validated milling center cleared in K240187. This involved assessing abutment angulation, diameter, height, wall thickness, tolerances, and part quality.
• Surface characterization (SEM and EDX) was done on the titanium base component to ensure no residual blast media.
• No clinical data were included in this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria, specific study details, sample sizes, expert involvement, or AI effectiveness. The clearance is based on non-clinical data and substantial equivalence to existing devices.

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The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.
The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.
The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.
The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

Atlantis® Abutment in Titanium refers to the following abutments that are the subject of this 510(k):

• Atlantis® Abutment,
• Atlantis® Crown Abutment,
• Atlantis® Conus Abutment, and
• Atlantis® Healing Abutment.

The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities.

Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities.

The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment in Titanium, including the Conus abutments and Healing abutments, are available in Titanium or Gold-shaded Titanium (titanium nitride layer applied using PVD (Physical Vapor Deposition)). The Crown Abutment is only available in Titanium.

The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration.

The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient.

The Atlantis® Conus abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis.

The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase.

Unless otherwise noted in this summary, the design envelope has remained unchanged from the previously cleared systems. Parameters such as gingival height and abutment diameter are dependent on the different implant system compatibilities.

The provided document is an FDA 510(k) clearance letter for Atlantis® Abutments in Titanium. This document indicates that the device has received clearance and is considered substantially equivalent to previously marketed devices. However, it is not a clinical study report and therefore does not contain the detailed information typically found in a study that proves a device meets acceptance criteria derived from a clinical trial.

Specifically, the document primarily focuses on non-clinical testing (e.g., MRI compatibility, biocompatibility, reprocessing, and CAD/CAM software validation) to support a labeling change and the substantial equivalence to predicate devices. It explicitly states:

• "8. Clinical Tests Summary and Conclusion: Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Therefore, I cannot extract the requested information (Acceptance Criteria Table, Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth Establishment) from this document as it pertains to a clinical study proving device performance against acceptance criteria.

The information from the document that is relevant to non-clinical testing and device characteristics is provided below.

Non-Clinical Testing and Device Characteristics from the 510(k) Clearance Letter

While a clinical study proving performance against acceptance criteria is not presented, the document does describe the non-clinical tests performed to support the device's safety and effectiveness and its substantial equivalence to predicate devices.

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

Since this is a 510(k) clearance notice based on substantial equivalence and non-clinical testing, there isn't a direct "acceptance criteria table" in the traditional sense of a clinical trial's performance endpoints. However, the document outlines standards and guidance documents used as criteria for the non-clinical tests, and the stated conclusion is that the device meets these requirements.

• ASTM F2213-17: Measurement of magnetically induced torque
• ASTM F2119-07 (2013): Evaluation of MR image artifacts from passive implants
• ASTM F2503-20: Marking medical devices for MR safety
• FDA guidance: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (October 10, 2023) | MR Conditional. Testing included in reference device (K221094) supports labeling update.
  The proposed Atlantis® Abutments in Titanium meet the requirements. |
  | Biocompatibility | - ISO 10993-1:2018: Biological evaluation of medical devices – Part 1
• ISO 10993-5:2009: Cytotoxicity testing | Biocompatibility assessment was performed and no new questions regarding biocompatibility are raised. Cytotoxicity testing was performed. |
  | Reprocessing (Sterilization Drying Time) | - ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D
• ANSI/AAMI/ISO 14937:2009/(R)2013, Annex D (Approach 3)
• AAMI TIR12:2020
• ANSI/AAMI/ISO TIR17665-2:2009
• FDA guidance: "Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling" | Reprocessing testing was performed to validate the proposed drying time for steam sterilization. The sterilization drying time validation followed the FDA guidance and relevant standards. |
  | CAD/CAM Software Validation & Verification (Atlantis® Abutment Milling) | To ensure that the same design limitations/constraints present in the 3Shape Atlantis® Abutment library match those in the internal CAD system, and that the design parameters cannot be exceeded. | Software validation was performed and confirmed that the additional option of using the 3Shape design module for design of Atlantis® Abutments does not raise new questions of safety and performance as it was confirmed that the locked design library has the same design limits as the internal VAD software. |
  | Mechanical Performance (Fatigue Testing) | - ISO 14801:2016: Implants – Dynamic loading test for endosseous dental implants
• FDA Guidance: Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance Document. | The internally documented and proposed modifications did not affect the performance of the devices and no new fatigue testing was needed. The abutments continue to meet the requirements. |

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

• Sample Size for Non-Clinical Tests: Not explicitly stated as numerical sample sizes (e.g., 'n=X implants'). The testing refers to meeting standard requirements (e.g., ASTM, ISO guidelines), which imply specific numbers of test units, but these are not provided in this summary document.
• Data Provenance: The testing was conducted by Dentsply Sirona (the manufacturer) and references previous FDA clearances (K numbers) and established standards. The data is part of the 510(k) submission to the FDA. The provenance of specific raw data (country of origin, retrospective/prospective) is not detailed in this 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):

• Not applicable. This document does not describe a process for establishing ground truth using human experts for the purpose of validating an AI/software device's diagnostic performance against human readers. The validation activity for the software (Atlantis® Abutment Milling) was to ensure its design limitations mirrored the internal CAD system and did not fall outside acceptable parameters.

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

• Not applicable. This is not a clinical study involving human interpretation or adjudication of findings.

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. The document explicitly states: "Clinical Tests Summary and Conclusion: Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence." Therefore, no MRMC study was conducted or reported.

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

• The "software validation" for "Atlantis® Abutment Milling" is a form of standalone performance evaluation for the CAD capabilities. It confirms that the software's design outputs (e.g., abutment geometry) from the 3Shape Abutment Designer Software conform to the established design envelope and limitations of Dentsply Sirona's internal CAD system (Virtual Abutment Design - VAD). This is a technical validation of the algorithm's design capability, not a diagnostic performance study.

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

• For the MR Safety testing, the ground truth or "reference standard" is the physical behavior of the device under MR conditions, measured against established ASTM standards and FDA guidance.
• For Biocompatibility, the ground truth is the biological response, evaluated against ISO standards.
• For Reprocessing, the ground truth is the effectiveness of sterilization and drying, validated against AAMI/ISO standards and FDA guidance.
• For CAD/CAM Software Validation, the "ground truth" for the 3Shape software is the "validated and locked design library" and "design limitations" of Dentsply Sirona's internal VAD software, ensuring the external software produces designs within the company's approved specifications.
• For Mechanical Performance (Fatigue Testing), the ground truth is the structural integrity and durability under dynamic loading, evaluated against ISO standards and FDA guidance.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set" in the context of supervised learning for diagnostic tasks. The software referred to (3Shape Abutment Designer Software) is a CAD software for design, not a machine learning model for prediction or classification.

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

• Not applicable, as there is no "training set" in the machine learning sense described in this document. The "ground truth" for the CAD software's validation was its adherence to the manufacturer's established design rules and limitations.

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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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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.

The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: Table 1.

The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software. CAM software, ceramic material, milling machine and associated tooling and accessories,

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ functions as an interface between a dental implant and a zirconia superstructure. It attaches to the implant using the included prosthetic screw and connects to the zirconia superstructure through cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.

The Elos Accurate® Hybrid Base™ is available for two types: Engaging and Non-Engaging.

• The Hybrid Base™ Engaging which is intended for single tooth dental restorations and having an indexing feature. which avoid the Hybrid Base from rotating in the implant.
• -The Hybrid Base™ Non-Engaging is intended for multiple tooth dental restorations and has no indexing feature, which allows the Hybrid Base to rotate in the implant.

The Elos Accurate® Hybrid Base™ is available with 4 different collar heights and is provided with a 7,5mm chimney which can be cut down to several heights by the user, to minimum 3,5 mm.

The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:

*The post height is defined as the cementable height of the abutment.

The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.

The Prosthetic Screw, also made of Titanium Alloy (ASTM F136), provided for the Elos Accurate® Hybrid Base™ is used to secure the final prosthetic restoration to the implant in the patient's mouth. The Prosthetic Screws have a hexalobular driver connection interface. The intended driver to be used with the Elos Accurate® Hexalobular Prosthetic Screws is the Elos Accurate® Prosthetic Screwdriver 18mm, 26mm or 34mm (Ref. No. PS-AH18-1, PS-AH26-1 or PS-AH34-1). These screwdrivers are Class I Exempt devices per FDA product code NDP.

The Elos Accurate® Hybrid Base has a gold anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K230317.

The subject prosthetic screws are provided anodized identical to reference device K120414.

The Elos Accurate® Hybrid Base™ and the Prosthetic screw is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient. The recommended sterilization procedure is full cycle pre-vacuum steam sterilization at a temperature of 132 °C (270°F) for 4 minutes. Dry time: 20 minutes.

The Elos Accurate® Hybrid Base™ is sold in 1 pc. packaging and the Elos Accurate® Prosthetic screw is sold in 1 pc. packaging.

The provided text does not describe an AI medical device. It is a 510(k) summary for a dental implant component, the Elos Accurate® Hybrid Base™. Therefore, it is impossible to extract the requested information about acceptance criteria and a study proving an AI device meets those criteria.

The document focuses on demonstrating the substantial equivalence of the Elos Accurate® Hybrid Base™ to a predicate device, primarily through:

• Similar Indications for Use and Intended Use: The device serves the same purpose as existing products.
• Comparable Design and Materials: It uses similar components (titanium alloy, zirconia) and design principles.
• Non-Clinical Testing: Fatigue testing (meeting ISO 14801), engineering and dimensional analysis, sterilization validation, digital dentistry workflow validation, and biocompatibility testing were performed. The fatigue testing is the closest parallel to performance testing, but it's for mechanical durability rather than diagnostic or analytical accuracy.

There is no mention of an algorithm, AI, machine learning, or any form of software that provides diagnostic or analytical outputs. Consequently, none of the specific questions about AI device performance metrics, training sets, ground truth establishment, or multi-reader studies can be answered from this document.

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Elos Accurate Hybrid Base
The Elos Accurate® Hybrid Base The intended for attaching to dental inplants in order to provide basis for dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:
Table 1.
Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm]
Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5
The zirconia superstructures for use with the Elos Accurate® Hybrid Base "" are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, ceramic material, milling machine and associated tooling and accessories.

Elos Accurate Customized Abutment
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutment is compatible with the implant systems listed in table 1: Table 1.
Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm]
Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5
Astra Tech 3.0 | Ø3. | Ø3
Astra Tech EV 3.0 | Ø3 | Ø3
All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ are both patient-specific components designed for attaching to dental implants, providing a basis for single or multiple tooth prosthetic restorations.
The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ will be attached to the implant using the included Elos Prosthetic Screw.
The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the pre-manufactured prosthetic component, the Hybrid Base in Titanium alloy per ASTM F136, as the bottom-half, and the zirconia superstructure as the top-half, which the laboratory/clinic is designing by use of the 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455), which when assembled comprises the finished medical device. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) While the Elos Accurate® Customized Abutment is a one-piece abutment which consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The same applies to the Elos Accurate® Hybrid Base™ which fits directly to an endosseous dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility.
The Elos Accurate library files for both Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ have built-in design limitations, and the user isn't allowed to exceed these limitations as follows:
Customized Abutments: | Hybrid Base abutments (zirconia part):
Min. wall thickness 0.4 mm | Min. wall thickness 0.5 mm
Gingival height min. 0.5mm or max. 5 mm | Gingival height min. 0.5mm or max. 5 mm
Max. angulation 20° or 30°. | Max. angulation 20°.
Min. post height* 4 mm | Min. post height* 4 mm
*The post height is defined as the cementable height of the abutment.
The Elos Accurate® Customized Abutment and the Elos Accurate® Hybrid Base™ are both delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient.

The provided text describes the submission of a 510(k) premarket notification for the "Elos Accurate® Hybrid Base™" and "Elos Accurate® Customized Abutment" dental devices. The purpose of this submission is to demonstrate that these devices are substantially equivalent to previously marketed predicate devices. The document details the indications for use, product descriptions, a comparison of technological characteristics with predicate devices, and a summary of non-clinical testing.

Here's an analysis of the acceptance criteria and the study proving device conformity:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in the document. Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "reported device performance" is primarily presented as the devices meeting the same or similar functional and safety standards as the predicate devices, with specific validations for expanded compatibility and design workflows.

The "Element of Comparison" table acts as a de facto set of acceptance criteria, where the subject device's characteristics are compared against the predicate devices, and "Substantial equivalent" is the reported "performance."

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

The document does not specify a "test set" in the context of an AI/human performance study. Instead, the testing described is primarily engineering and material characterization:

• Fatigue testing per ISO 14801: This testing involves multiple samples to assess mechanical durability. While the exact number of samples isn't given, standard ISO 14801 typically requires a significant number of samples tested to failure or for a specified number of cycles.
• Biocompatibility testing for cytotoxicity (ISO 10993-5): This testing would use biological samples or cell lines. The document states it's leveraged from previously cleared products (K230317/K231317) on "identically manufactured abutments and prosthetic screws manufactured from the same material."
• Sterilization validation (ISO 17665-1 & ISO 17665-2): Involves using Biological Indicators (BIs) or other validation methods, typically multiple cycles and samples. Leveraged from K230317/K231317.
• MRI Conditional Safety Evaluations (ASTM F2052, ASTM F2119, ASTM F2213, ASTM F2182): A "worst-case assembly" was tested, implying at least one, but possibly multiple, physical assemblies to cover various MRI conditions. Leveraged from K230317/K231317.
• Digital dentistry workflow validation: Conducted on "selected model of subject product lines," implying a representative set of designs.

Data Provenance: The data comes from non-clinical testing performed by the manufacturer (or leveraged from prior submissions by the same manufacturer, Elos Medtech Pinol A/S). The origin is Denmark (company location). The testing is prospective for the current submission but leverages retrospective data from previous clearances.

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

This information is not applicable to this submission. The device is a physical dental abutment, not an AI/diagnostic device that generates an output requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its physical, mechanical, and biological properties, which are established through standardized engineering and laboratory tests, not expert consensus on diagnostic images.

4. Adjudication method for the test set

This is not applicable as there is no test set involving expert interpretation or a diagnostic outcome that would require 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

This is not applicable as the device is a physical dental abutment, not an AI-assisted diagnostic tool or software.

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

This is not applicable as the device is a physical dental abutment. The "digital dentistry workflow" involves software (3Shape Abutment Designer Software) but this is used for design and manufacturing, not for standalone diagnostic performance assessment.

7. The type of ground truth used

The "ground truth" for this engineering-focused submission is established through:

• Engineering and dimensional analysis: Measurements and specifications of various components (abutments, implants, screws).
• Mechanical testing: Fatigue testing per ISO 14801 to assess durability and strength under simulated physiological loading.
• Biocompatibility testing: Standardized testing (ISO 10993-5) to confirm non-cytotoxicity.
• Sterilization validation: Standardized testing (ISO 17665-1 & ISO 17665-2) to confirm sterility.
• MRI compatibility testing: Standardized testing (ASTM F2052, ASTM F2119, ASTM F2213, ASTM F2182) to confirm MR conditional status.
• Design software validation: Testing that the software (3Shape Abutment Designer) adheres to "built-in design limitations" and prevents users from exceeding them.

8. The sample size for the training set

This is not applicable. The submission is not for an AI/machine learning device that requires a training set. The descriptions of "design limitations" and "digital dentistry workflow validation" refer to the validation of software and manufacturing processes, not the training of an algorithm in the machine learning sense.

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

This is not applicable as there is no training set for the reasons outlined above. The "design limits" mentioned for the digital dentistry workflow are predefined by Elos Medtech based on engineering principles and safety considerations for dental prosthetics.

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be designed using AbutmentCAD software in the digital dentistry workflow, as well as add angulation to some of the Pre-Milled (Blank) Abutments. The subject devices are to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. The proposed change is to allow the subject devices to be designed using AbutmentCAD by exocad GmbH, the current workflow allows only the use of 3Shape by 3Shape A/S for the design software. Another purpose of this submission is to expand the design parameters to allow angulation (up to 30°) on Pre-milled (Blank) Abutments that are compatible with Neodent Grand Morse, Nobel Active/Nobel Parallel Conical 3.0 mm, and Straumann BLX implants. There are no changes to the abutment design or implant compatibilities. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows in under K221301.

The subject device DESS Dental Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.

All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, titanium and ceramic material, milling machine and associated tooling and accessories.

The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The digital workflow includes the following products (not subject devices of this submission):

• Ceramic material: VITA YZ ST and VITA YZ XT (K180703)
• . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• . Intraoral Scanner: 3Shape TRIOS A/S Series Intraoral Scanner (510(k) exempt under 21 CFR 872.3661)
• Desktop scanner: 3Shape D900 Dental Lab Scanner (510(k) exempt under 21 CFR 872.3661)
• Abutment design software: 3Shape Abutment Designer Software (K151455) and AbutmentCAD ● (K193352)
• . Milling machine: VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software

The provided text describes a 510(k) premarket notification for DESS Dental Smart Solutions, which are dental implant abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's effectiveness through clinical performance studies with specific statistical acceptance criteria for accuracy, sensitivity, or specificity.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics like accuracy, sensitivity, specificity).
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

The study described in this document focuses on non-clinical performance data to demonstrate substantial equivalence, specifically:

1. Sterilization validation: According to ISO 17665-1, ISO 17665-2, and ISO 14937.
2. Biocompatibility testing: According to ISO 10993-5 and ISO 10993-12.
3. Fatigue testing and reverse engineering analysis: Of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility. This includes fatigue testing of OEM implant bodies with patient-specific abutments made at worst-case angled conditions.
4. MR Conditional labeling.
5. Validation testing of CAM restriction zones: Including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in the CAM software.
6. Software verification: Included testing of restrictions that prevent design of components outside of the stated design parameters. The abutment design library was validated to demonstrate that established design limitations and specifications are locked and cannot be modified by the user.

The acceptance criteria and reported "performance" for this submission are based on these engineering and design validations, ensuring the device meets safety and performance standards equivalent to the predicate device, K221301. The key "performance" metrics are about maintaining physical and material integrity and compatibility.

The core of the submission is to expand the DESS Dental Smart Solutions abutment system to:

• Allow design using AbutmentCAD software (in addition to 3Shape software).
• Add angulation (up to 30°) to some Pre-milled (Blank) Abutments for specific implant systems.

The document explicitly states: "No clinical data were included in this submission." and "The subject device, the predicate device, and reference devices have the same intended use, technological characteristics, and are materials. The subject device, the predicate device, and reference devices encompass the same range of physical dimensions, manufactured by similar methods, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above."

Therefore, this FDA submission is for a physical medical device (dental implant abutment) and its manufacturing/design software modifications, not an AI or diagnostic device that would involve clinical performance metrics like sensitivity or specificity.

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The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutument is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided document, K231307 for Elos Accurate® Customized Abutment, is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial or a performance study for an AI/ML powered medical device would.

The "acceptance criteria" discussed in this document pertain to the device meeting the requirements for FDA 510(k) clearance by demonstrating substantial equivalence to predicate devices, primarily through engineering, dimensional, and non-clinical testing. There is no mention of a human-in-the-loop study, a multi-reader multi-case (MRMC) study, or an AI/ML algorithm-only standalone performance study.

Therefore, many of the requested fields regarding expert adjudication, MRMC studies, and ground truth establishment for AI/ML models are not applicable to the information contained within this 510(k) submission.

Here's an interpretation of the document's contents in relation to your request, with a focus on non-clinical testing and substantial equivalence:

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

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicates and meeting established material and dental implant abutment standards. The document doesn't present a table with numerical acceptance criteria and performance for a diagnostic AI algorithm. Instead, it lists various non-clinical tests and their successful outcomes as evidence of substantial equivalence and safety/effectiveness.

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

• Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of abutments or implants tested for each reported non-clinical test. The tests are general performance validations (e.g., fatigue, cytotoxicity, sterilization efficacy) and dimensional analyses that demonstrate compliance with relevant standards or a worst-case scenario. For example, fatigue testing often involves a small number of samples (e.g., 6 minimum per ISO 14801, though more are often used for statistical power) under specific loading conditions. Similarly, biocompatibility is performed on representative samples.
• Data Provenance: The data comes from the manufacturer's (Elos Medtech Pinol A/S) internal testing and leverages data from previously cleared devices where material, size, and geometry are substantially equivalent. The provenance is therefore the manufacturer's testing facilities and associated regulatory submissions. There is no indication of different countries of origin for the data concerning these non-clinical tests. The tests are prospective in nature, as they are part of the premarket submission process.

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

This question is not applicable. The "ground truth" for this medical device (dental abutment) is established by engineering specifications, material properties, performance standards (e.g., ISO, ASTM), and clinical safety and effectiveness data from the predicates. There is no AI/ML component described that would require expert human review or "ground truth" establishment in the context of diagnostic interpretation.

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

This question is not applicable as there is no human interpretation or diagnostic "test set" that would require 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

This question is not applicable. The device is a physical dental abutment and its associated digital design workflow, not an AI-powered diagnostic tool requiring human reader studies.

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

This question is not applicable. The device is not a standalone AI algorithm. The digital dentistry workflow involves CAD software and CAM software, but these are tools for designing and manufacturing the physical abutment, not for automated diagnostic interpretation or decision-making in the clinical sense of an AI/ML algorithm.

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

The "ground truth" for this device's performance, as demonstrated in the submission, is based on:

• Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665 for sterilization).
• Engineering and dimensional analysis against established dental implant system specifications.
• Physical testing results (e.g., torque, heating, displacement) for MR compatibility.
• Validation of the digital workflow ensuring design constraints and manufacturing accuracy.
• The fundamental demonstration is substantial equivalence to existing legally marketed predicate devices, implying that their established safety and effectiveness forms the basis of the "ground truth" for this device's intended use.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML device that requires a training set for model development. The design software has built-in constraints ("design limitations" and "design limits in the library file"), which are more akin to pre-programmed rules and geometric parameters rather than a learned model from data.

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

This question is not applicable. No AI/ML training set is mentioned or implied. The "ground truth" for the design limitations within the software (e.g., minimum material thickness) would be established by engineering principles, biomechanical studies (often in labs, not clinical trials), and clinical experience with dental prosthetics, which define safe and effective design parameters.

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The Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The ASC Solution Abutments and SI-BASE Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.0 External-Hex implants, Ø3.3 PROVATA implants and Ø3.5/Ø4.0 Deep Conical implants are intended for use with a straight mesostructure component.

The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.4 and Ø4.0 External-Hex implants. PROVATA implants and 03.5 and 04.3 TRI-NEX implants is limited to replacement of maxillary and mandibular lateral and central incisors.

The ASC Solution Abutments and SI-BASE Abutments for Compact Conical Abutments are intended for use on straight Compact Conical Abutments with a straight mesostructure component.

This submission includes two major components which make up the ASC Solution and SI-BASE Abutments - The ASC Solution and SI-BASE Abutment Base and the mesostructure restoration. Twopiece and three-piece abutments models are included. Two-piece abutments consist of the ti-base abutment and mesostructure. Three-piece abutments consist of the ti-base abutment, mesostructure, and compatible compact conical abutments.

The ASC Solution and SI-BASE Abutments are standard premanufactured titanium alloy abutments for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The ASC Solution and SI-BASE Abutments then serve as the interface between the endosseous implant and the zirconia restoration. The abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The ASC Solution and SI-BASE Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The abutments are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by Titanium nitride coating (ASC Solution Abutments) or yellow anodizing (SI-BASE Abutments). The TiN coating and anodization processes are the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Intra-oral scanner: 3Shape E3 Desktop Scanner
• Abutment design software: 3Shape Abutment Designer Software (K151455)
• Milling machine: Roland DWX51D Milling Unit

The provided text describes the Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments for dental implants. The document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

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

The document does not explicitly state "acceptance criteria" in a quantitative manner with defined thresholds. Instead, it demonstrates compliance through comparison to predicate devices and adherence to relevant standards and guidance documents. The "reported device performance" is largely qualitative and comparative, focusing on demonstrating equivalence rather than meeting specific numerical performance targets.

However, based on the "PERFORMANCE DATA" section and "Table of Substantial Equivalence", we can infer the following:

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

• Sample Sizes for Test Set:
  • Biocompatibility: Not explicitly stated as a number of devices. The statement mentions "materials are identical in formulation, processing, component interactions, and storage conditions to the predicate device" and "biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1... and ISO 10993-5 'Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity' was performed." This implies biological samples were used for in-vitro cytotoxicity, but the number is not specified.
  • Mechanical Performance (Fatigue): "Dynamic testing was performed on worst-case subject device constructs." The exact number is not provided, but typically, mechanical fatigue testing involves a statistically significant number of samples per "worst-case construct" to establish fatigue limits.
  • Software Validation: Not explicitly stated as a numerical sample size. It involved verification and validation for the "abutment design library" and screenshots under user verification testing, indicating a functional test rather than a numerical sample size.
  • MR Safety: Not explicitly stated for the subject device. It refers to testing performed on "previously cleared devices, K222457, PROVATA Implant System."
• Data Provenance: Not explicitly stated for any of the tests. Given it's a 510(k) summary, the testing was likely conducted by or on behalf of Southern Implants (Pty) Ltd, which is located in "Irene, Gauteng, 0062 South Africa." The studies appear to be non-clinical (bench testing) and retrospective in the sense that they rely on comparisons to previously cleared devices and established standards, rather than new prospective human clinical trials.

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

This information is not provided in the document. The studies described are primarily non-clinical bench testing, software validation, and biocompatibility assessments, which typically do not involve establishing "ground truth" through expert consensus in the way a diagnostic AI device would. Instead, performance is measured against engineering specifications, standards (like ISO 14801), and equivalence to predicate devices.

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

This information is not applicable to the types of non-clinical, hardware-focused studies described. Adjudication methods are typically used in clinical studies or studies evaluating subjective interpretations (e.g., image reading) to establish a consensus ground truth.

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

There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a component for dental implants (abutments), not a diagnostic AI system or an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical medical component (dental abutment) and related software for design. While software validation was performed, it's for design limitations and functionality, not for an "algorithm only" performance in a diagnostic or interpretive sense. The "standalone" concept typically applies to AI algorithms that provide a diagnosis or interpretation without human intervention.

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

The concept of "ground truth" as it applies to diagnostic or prognostic data is not directly applicable to these non-clinical studies. Instead, the "truth" or reference for the tests described is:

• Biocompatibility: Established biological safety standards (ISO 10993-1, ISO 10993-5) and comparison to predicate device materials.
• Mechanical Performance: International standard ISO 14801 for dynamic fatigue testing of dental implants and abutments. This involves objective physical measurements.
• Software Validation: Functional specifications of the software and demonstration that defined design limitations are enforced.
• MR Safety: FDA guidance document recommendations and physical testing methods to determine MR compatibility.

8. The sample size for the training set

This information is not applicable. This device is not an AI diagnostic or predictive algorithm that requires a training set in the conventional sense. The "design workflow" involves CAD/CAM software but this refers to a process for custom fabrication, not machine learning model training.

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

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

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The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations.

The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

• SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors.
• SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandbular and maxillary central and lateral incisors.
• SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

The SMARTbase Abutment System is a two-piece engaging and non-engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). There are three device lines offered in the SMARTbase Abutment System: Legacy™ SMARTbase Abutment, InterActive™ SMARTbase Abutment, and SMARTbase Cylinder.

The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm for Legacy™ and 3.0mm, 3.4mm for InterActive™, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The SMARTbase Cylinder is a two-piece non-engaging dental implant and multi-unit abutment cylinder comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The SMARTbase Cylinder is offered in two heights 9.0mm (that can be shortened to 4.0mm) and 4.0mm and in one width, platform diameters and collar (titanium base) height in order to accommodate different patient anatomies.

The subject device is supplied with fixation screws that function as an extension of the implant or multi-unit abutment to which the SMARTbase Abutment or SMARTbase Cylinder is secured and is used with several accessories in digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.

The available design options for the zirconia top components to be provided either as a superstructure (to then receive a separate crown or bridge) or hybrid abutment-crown. There are three workflow options for fabricating the zirconia top component which fits the titanium abutment base:

(1) end user creation of a press-ceramic material by conventional wax-up technique,

(2) Implant Direct design and milling of zirconia in stock sizes using ceramic material of ZirCAD Prime (K142233) and provision of same to the end user, and

(3) digital workflow using 3Shape or Exocad software where CAD design and milling of the superstructure or hybrid crown component is done at the end user's dental laboratory/office; the CAD design requires loading of Implant Direct's abutment design library to the 3Shape or Exocad software to design the superstructure or hybrid crown component within the established design limitations and specifications. The digital workflow includes use of the following products (not subject devices of this submission):

• Ceramic material: ZirCAD Prime (K142233) .
• . Cement: Maxcem Elite Self-Etch/Self-Adhesive Resin Cement (K060469)
• . Composite: Kerr Harmonized (K151332)
• Intra oral scanners: Medit Scanner, ITero Scanner Trios Scanner, CareStream . Scanner
• Abutment design software: 3Shape Abutment Designer™ Software (K151455) and • Exocad AbutmentCAD Software (K193352)
• . Milling machine: Wieland-Zenotec Select, Zenotec CAM, iCAM V5, and imes icore

This document describes a premarket notification for the "SMARTbase Abutment System," a dental implant abutment. The document focuses on demonstrating that the new device is substantially equivalent to existing predicate devices through various performance tests.

Here's an analysis of the acceptance criteria and the studies performed, 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 with corresponding performance results in a single, clear format for each test. Instead, it states that "The test results support that the Subject Device met the performance specifications as intended." and "The difference does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent."

However, we can infer the types of performance tests and the general acceptance (i.e., compliance) from the "x. Performance Testing Data" section.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of abutments subjected to fatigue testing).
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that this is a premarket notification for regulatory clearance, the testing would generally be conducted by the manufacturer or a contract research organization on manufactured devices, following established protocols. It is non-clinical testing, meaning it's not performed on patients.

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

This question is not applicable as the document describes non-clinical performance testing for a medical device (dental abutment), not studies involving expert evaluation of diagnostic outputs or ground truth for AI algorithms. The "ground truth" here is defined by engineering standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. Adjudication methods (like 2+1) are typically used for establishing ground truth in clinical or diagnostic studies involving human interpretation or pathology.

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

This question is not applicable. The document describes non-clinical performance testing of a physical dental abutment and associated design software. It does not involve human readers, cases, or AI assistance in a diagnostic context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

For the software component:

• Standalone Performance: Yes, standalone software verification and validation testing was performed for the abutment design library. This testing demonstrated that the software's inherent design restrictions and specifications for creating the top half of the two-piece abutment prevent designs outside allowable limitations and that the design limitations are locked and cannot be modified. This is essentially an "algorithm only" test to ensure the software functions as designed within its specified parameters.

7. The Type of Ground Truth Used

• For Physical Device Performance (Fatigue, MR Compatibility, Biocompatibility, Sterilization, Shipping): The ground truth is based on established international and national standards (e.g., ISO 14801, ISO 10993-1, ISO 17665-1, ASTM F2052, ASTM D4169). Compliance with these standards serves as the "ground truth" for acceptable mechanical, safety, and operational performance.
• For Software Verification & Validation: The ground truth is the defined design limitations and specifications established by the manufacturer for the abutment components. The software's ability to enforce these limitations (preventing designs outside them and locking specifications) constitutes meeting this "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical dental abutment and associated design software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data to make predictions or classifications. The "training" for the software is its programmed adherence to design rules and specifications.

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

This question is not applicable for the same reasons as #8. There is no training set mentioned for an AI/ML model. The software's functional parameters are established through engineering design and specifications.

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