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• Missing tooth structure
• Defective restorations

Adhese Universal DC is a dual-curing, single-component dental adhesive for enamel and dentin that is compatible with all etching techniques (self-etch, selective enamel etch, etch & rinse techniques). The areas of application include adhesive cementation of indirect restorations and direct restorative procedures. Adhese Universal DC is available in Free Stand Single Dose units. The applicator is coated with co-initiators required for the self-curing reaction. The initiator and adhesive are mixed together by dipping the applicator into the single dose unit containing the liquid Adhese Universal DC.

The report describes "Adhese Universal DC," a dual-curing dental adhesive. It uses the "Adhese Universal" (K133318) as its predicate device. The information provided heavily focuses on the comparison between the proposed device and the predicate device, especially regarding their working principles, chemical composition, and performance specifications.

Here's an analysis of the provided information concerning acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

Deviation Summary: The proposed device, Adhese Universal DC, has a lower acceptance criterion for shear bond strength (Dentin) at ≥20 MPa compared to the predicate's ≥25 MPa. This is explicitly noted in the document, attributing the lower value to the self-curing mode of Adhese Universal DC, which generally exhibits lower values.

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

The document mentions "Bench testing was performed to test the physical property (shear bond strength)." However, it does not provide any specific sample sizes for this testing.

Regarding data provenance, the document does not specify the country of origin of the data. It indicates the testing was "Bench testing," implying laboratory-based testing, but does not clarify if it was retrospective or prospective in data collection approach.

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

This information is not provided as the "test set" and "ground truth" concepts as typically applied to AI/software validation studies (with human experts evaluating outputs) are not relevant here. This is a material science study focused on physical properties, not diagnostic accuracy requiring expert consensus.

4. Adjudication Method for the Test Set

This is not applicable as the study is a bench test measuring physical properties, not a clinical trial or diagnostic accuracy study requiring adjudication of expert opinions.

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

This is not applicable. An MRMC study is relevant for assessing human reader performance in conjunction with AI. This document describes the performance of a dental adhesive, not an AI system.

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

This is not applicable. The device is a dental adhesive, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured physical property of "Shear bond strength (Dentin)" obtained through laboratory bench testing according to established standards. It's an objective measurement rather than expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic studies.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" relates to machine learning models. This document describes a physical product, not a software algorithm.

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

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

Summary of the Study and How it Proves Acceptance Criteria:

The study proving the device meets its acceptance criteria is a non-clinical performance bench test. Specifically, it involved measuring the shear bond strength (Dentin) of the Adhese Universal DC in its self-curing mode.

The acceptance criterion for Adhese Universal DC's shear bond strength (Dentin) in self-curing mode was set at ≥20 MPa. While the document states that "The specification for Adhese Universal DC describes lower values (20 MPa) for shear bond strength (dentin) compared to Adhese Universal (25 MPa) due to the self-curing mode," it does not explicitly report the obtained value from the bench testing for Adhese Universal DC. It only states the specification. To definitively prove the device meets the acceptance criteria, the actual measured performance data of Adhese Universal DC on shear bond strength would need to be compared against the ≥20 MPa criterion. The document implies compliance through the "Summary of Performance Specification" which states, "The specification for Adhese Universal DC describes lower values (20 MPa) for shear bond strength (dentin) compared to Adhese Universal (25 MPa) due to the self-curing mode of Adhese Universal DC which generally shows lower values." This statement argues for the reason for the lower criterion but doesn't report the achieved value against that criterion.

The study also included Biocompatibility testing according to ISO 10993-1:2018, ISO 7405:2018, and ISO 14971:2012. The conclusion from this testing was that "The results of the Biocompatibility Assessment for Adhese Universal DC is substantially equivalent to the results of the Biocompatibility Assessment for the predicate device Adhese Universal." This demonstrates the device meets biocompatibility safety criteria by showing equivalence to a legally marketed predicate.

In essence, the study framework described is a comparative non-clinical bench study focusing on physical properties and biocompatibility to establish substantial equivalence to a predicate device for regulatory clearance.

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Missing tooth structure in anterior and posterior teeth

Types of restorations:

• Veneers

• Inlays

• Onlays (e.g. occlusal veneers, partial crowns)

• Crowns

IPS e.max® One is a glass-ceramic block for the fabrication of fixed, full-contour single-tooth restorations in anterior and posterior teeth. IPS e.max One can be processed in milling machines and polished afterwards. A crystallization process is not necessary. The dentist starts with shade selection, preparation of the tooth based on guidelines for all-ceramic restorations, follow the recommended griding instruments and minimum layer thickness during finalizing and finishing, and finish with dental polishing.

Types of restorations: -Veneers -Inlays -Onlays (e.g. occlusal veneers, partial crowns) -Crowns

This document describes the premarket notification for the IPS e.max® One dental material. As such, it does not contain details of an AI/ML powered medical device. Therefore, the requested information on acceptance criteria, reader studies, and ground truth for an AI/ML device is not applicable and cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of the IPS e.max® One to a predicate device, IPS e.max CAD (K051705), based on non-clinical performance testing and biocompatibility.

Here's the relevant information about the non-clinical performance testing:

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document states "Bench testing was performed... according to EN ISO 6872:2015" for these properties. It does not provide specific numerical results of the performance.

2. Sample size used for the test set and the data provenance: Not applicable. This is a material test, not a test on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for material properties is defined by the standards and physical testing methodologies.

8. The sample size for the training set: Not applicable. This is material testing, not an AI model.

9. How the ground truth for the training set was established: Not applicable.

Biocompatibility:

The biocompatibility evaluation was performed according to ISO 10993-1:2009, ISO 7405:2018, and ISO 14971:2019. The evaluation concluded:

• Not cytotoxic
• No sensitizing potential for lithium disilicate glass-ceramic blocks (LS2)
• Does not induce oral mucosal irritation
• No potential for material-mediated pyrogenicity
• No risks for acute, sub-acute, sub-chronic toxicity
• Not genotoxic
• Negligible risk of carcinogenicity
• No direct contact to pulp or dentin.

Conclusion of the study:

The study concludes that IPS e.max® One is substantially equivalent to the predicate device IPS e.max CAD based on the non-clinical performance testing and biocompatibility assessment, despite differences in chemical composition and the elimination of a crystallization step for the new device. The new device covers similar indications (veneers, inlays, onlays, and crowns) but lacks the indication for bridges that the predicate device has.

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Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months).
The system comprises three parts:

• Telio CAD Abutment Solutions
• Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991)
• CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520)
  Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below:
  -Implant systems:
  The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems:
• AstraTech Osseospeed (Dentsply Sirona K130999, K091239)
• Frialit/Xive (Dentsply Sirona K013867))
• internal connection (BioHorizons K143022, K071638, K093321, K042429)
• Replace (Nobel Biocare K020646)
• Nobel Active (Nobel Biocare K071370)
• Bränemark® (Nobel Biocare K022562)
• Tissue Level (Straumann K061176)
• Tapered Screw-Vent (Zimmer K061410)
• Camlog Screw-Line (Camlog K083496)
• Conelog Screw-Line (Camlog K113779)
• iSy (Camlog K133991)
• Osstem TS (Osstem (USA: Hiossen) K121585)

The Telio® CAD Abutment Solutions- extra systems which is the subject of this premarket notification is a modification to the Telio Abutment Solutions as previously cleared under K151564. The modifications represented in the subject device consist of the addition of 14 extra implant systems to the 2 previously cleared implant systems. The device Telio CAD (K093708) is currently cleared by the FDA as a Crown and Bridge, Temporary Resin (21 C.F.R§872.3770) because it is a device that offers a rapid route to effective temporary restorations. The currently cleared Telio CAD Abutment Solutions (K151564) included the system Straumann Bone Level, but not all the parts of this system (i.e. NC) were mentioned. This submission includes 14 additional systems.
Telio CAD Abutment Solutions- extra systems is intended for use in single hybrid abutment crowns for temporary restoration (up to 12 months). Telio CAD Abutment Solutions is a system comprising of three parts: Telio CAD Abutment Solution, cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base, utilizing Sirona CAD/CAM System to design and fabricate long term temporaries by means of the CAD/CAM technique. The abutments being two-piece titanium base abutments are mated with a PMMA top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment.
For the fabrication of Telio CAD Abutment Solutions, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan, depending on the CAD/CAM system used. For notes regarding the scan, please observe the manufacturer's instructions for use of the CAD/CAM system.

Here's a breakdown of the acceptance criteria and study information for the Telio® CAD Abutment Solutions- extra systems device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Mechanical Properties (Flexural Strength, Water Sorption, etc.): The specific number of samples for each mechanical test (Flexural Strength, Water Sorption, Solubility, Flexural Modulus, and Ball Indentation Hardness) is not specified in the provided document. It only states that "Bench testing was performed" and "The subject device was tested in direct comparison to the predicate device."
• Sample Size for Dynamic Fatigue: The document states "The fatigue testing performed for the listed extra systems proves that Telio CAD Abutment Solutions can be used with the 14 additional implant systems." However, the exact sample size (number of devices tested for dynamic fatigue) for each implant system is not specified.
• Data Provenance: This information is not available in the provided document. The document refers to standards (EN 1641:2009, ISO 14801:2007) but does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

• This information is not applicable as the studies described are bench testing (mechanical and fatigue testing), which rely on objective measurements and established standards, rather than expert interpretation of data like in clinical trials or image analysis.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies described are bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This information is not applicable. The device is a dental abutment system and not an AI-powered diagnostic or assistive tool for human readers.

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 dental abutment system and does not involve an algorithm.

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

• For the mechanical properties tests (Flexural Strength, Water Sorption, etc.), the "ground truth" is established by the specified standards (EN 1641:2009), which define the measurement methodologies and often acceptable ranges or comparisons to predicate devices.
• For the dynamic fatigue testing, the "ground truth" is defined by the standard ISO 14801:2007, which outlines the load and cycle requirements for endosseous dental implants. The goal is for the device to meet or exceed the performance specified in this standard.

8. The Sample Size for the Training Set

• This information is not applicable as the device is a dental abutment system and does not involve machine learning algorithms that require a training set.

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

• This information is not applicable for the reasons stated above.

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For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.

Cervitec®F is a dental varnish for the treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces. The varnish system is characterized by its good moisture tolerance during application. Cervited in either a Tube (4gm, 7gm) or Single Dose (0.26gm) delivery form.

The provided document describes the substantial equivalence of the Cervitec F dental varnish to its predicate devices, primarily Fluor Protector S (K131487), based on non-clinical performance testing and biocompatibility assessments. It does not contain information about a study proving the device meets acceptance criteria related to its clinical efficacy in treating dentinal hypersensitivity or exposed dentin and root cervical surfaces using metrics typically found in medical device studies (e.g., sensitivity, specificity, AUC).

Instead, the acceptance criteria and supporting study are focused on demonstrating that Cervitec F adheres to a relevant standard for fluoride varnishes and is biocompatible.

Here's a breakdown of the information available based on your request:

1. Table of acceptance criteria and the reported device performance:

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

• Non-clinical performance testing (ISO 17730:2014): Not explicitly stated. The document mentions "Specific physical properties have been assessed and verified," but details on the number of samples or methodology are not provided. These are generally laboratory tests on product batches.
• Biocompatibility testing: Not explicitly stated. Biocompatibility tests usually involve in vitro assays and in vivo animal studies, but the number of samples or subjects is not mentioned.

The provenance of this data is internal testing conducted by the manufacturer, Ivoclar Vivadent AG, to demonstrate compliance with international standards. It's retrospective in the sense that these tests were performed to support the 510(k) submission.

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

This information is not applicable and not provided. The "ground truth" for the non-clinical performance and biocompatibility refers to the established standards (ISO 17730:2014, EN ISO 10993-1:2009, EN ISO 7405:2008) themselves, and the device's adherence to their requirements as measured through laboratory and biological tests. There are no human "experts" establishing a clinical ground truth for image interpretation or diagnosis in this context.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human reader interpretations are compared. This document describes non-clinical and biocompatibility testing.

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

No. This type of study (MRMC, AI assistance) is not mentioned and is not relevant for a dental varnish approval for dentinal hypersensitivity. The device is a direct treatment, not a diagnostic or AI-powered assistive technology for human readers.

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

Not applicable. This device is a manual application dental varnish, not an algorithm.

7. The type of ground truth used:

• For non-clinical performance: The ground truth is defined by the specifications set out in the international standard EN ISO 17730:2014 "Dentistry – fluoride varnishes," particularly regarding the total fluoride content.
• For biocompatibility: The ground truth is established by the accepted scientific and regulatory principles for biocompatibility testing as outlined in EN ISO 10993-1:2009 and EN ISO 7405:2008, determining whether the material elicits an adverse biological response.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."

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

Not applicable, as there is no training set.

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Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment of the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

The provided text describes the 510(k) premarket notification for "Barrier Sleeves" by Ivoclar Vivadent, AG. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's independent efficacy through a "study that proves the device meets the acceptance criteria" in the context of, for example, an AI/ML medical device.

The "acceptance criteria" here are based on the similarity to the predicate device and meeting established performance standards for surgical drapes/barrier materials. The study described is a series of non-clinical bench tests and biocompatibility assessments.

Here's how to structure the information based on your request, with the understanding that this is not an AI/ML device study, but rather a traditional medical device submission for substantial equivalence:

Device: Barrier Sleeves (K191448)

Intended Use: "Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only."

The claim of substantial equivalence is supported by demonstrating that the Barrier Sleeves have the same intended use, fundamental technology, working principle, material composition, and comparable performance properties to the predicate device (Disposable Barrier Sleeves and Covers, K160232) manufactured by the same supplier.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are implied by demonstrating equivalence to a legally marketed predicate device and meeting relevant industry standards for barrier materials. The study is a series of physical and biological tests.

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

The document does not explicitly state specific sample sizes for each non-clinical test (e.g., how many sleeves were tested for blood penetration). It refers to "the samples" for mechanical properties.

• Sample Size: Not explicitly stated for each test, generally referred to as "the samples."
• Data Provenance: Non-clinical bench testing conducted by the manufacturer for the purpose of this 510(k) submission. The document doesn't specify country of origin for the testing itself, but the submitter (Ivoclar Vivadent) is based in New York, USA, and the parent company in Liechtenstein. The material supplier is Minitube AB, Sweden. The tests are prospective, conducted specifically for this submission.

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

This section is not applicable for this type of medical device submission. Ground truth, in the context of AI/ML or diagnostic devices, is typically established by medical professionals reviewing images or patient data. For a barrier sleeve, "ground truth" refers to meeting the chemical, physical, and biological performance standards, which are evaluated by laboratory testing under defined ASTM and ISO standards, not by expert medical review of "cases."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human reviewers of medical data (e.g., radiologists interpreting images). The "test set" here involves laboratory measurements against established standards.

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

No. MRMC studies are performed to assess the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical barrier and does not involve human interpretation or AI assistance.

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

Not applicable. This is not an algorithmic or software device.

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by established engineering and biocompatibility standards (e.g., ASTM F1670/F1670M for synthetic blood penetration, ISO 10993-5 for cytotoxicity). The device performance is measured against these standards and compared to the predicate device. It is not based on medical outcomes data or expert consensus in the diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As per point 8, there is no training set for this device.

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IPS e.max® CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

• IPS e.max CAD ceramic structure
• Ti base
• CAD/CAM system.

The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The compatible Implant systems, titanium bases and CAD/CAM systems are shown below: -Implant Systems:

• Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867)

• BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429),

• Osstem: TS Implant System (K121585)

• Straumann: Tissue Level RN/WN (K061176)

• Nobel Biocare: Branemark (K022562)

• Zimmer: Tapered Screw-Vent (K061410)

• Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991)

• CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520)

-Titanium Bases: Dentsply Sirona TiBase, Camlog TiBase

The IPS e.max® CAD Abutment Solutions- extra systems Device Description: which is the subject of this premarket notification is a modification to the IPS e.max CAD Abutment Solutions as previously cleared under K132209. The modifications represented in the subject device consist of the addition of 11 extra Ti-Bases to the 4 previously cleared Ti-Base compatibilities.

IPS e.max CAD Abutment Solutions- extra systems is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. IPS e.max CAD Abutment Solutions is a system comprising IPS e.max CAD ceramic structure, Sirona TiBase and Sirona CAD/CAM System to design and fabricate the ceramic structure. The abutments being two-piece titanium base abutments are mated with a ceramic top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment.

For the fabrication of IPS e.max CAD Abutment Solutions and depending on the CAD/CAM system used, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan. Updated material and TiBase library datasets relating to Sirona Dental CAD/CAM System with CEREC chairside software are obtained by download at: https://my.cerec.com.

IPS e.max CAD Abutment Solutions are lithium disilicate blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already included in the shipped block. The connection geometry fit select Titanium Bases as identified in the Indications for Use. The mesostructured is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown. The device serves as the esthetic mesostructured which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.

The document describes the regulatory submission for the IPS e.max® CAD Abutment Solutions- extra systems (K191382). This device is a modification of a previously cleared device (K132209) and primarily focuses on the addition of new compatible titanium bases for various implant systems.

The acceptance criteria and study information are derived from the "Testing Summary" and "Conclusion" sections.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily discusses the substantial equivalence of the modified device to its predicate, focusing on adding new compatible implant systems. The primary performance characteristic assessed is fatigue strength.

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

The document states, "The fatigue testing performed for the listed extra systems proves that IPS e.max CAD Abutment Solutions can be used with the 11 additional implant systems." However, specific sample sizes (e.g., number of test specimens per implant system) are not explicitly provided in the provided text for the fatigue testing. The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The type of testing described (dynamic fatigue) is a bench-top mechanical test, not reliant on expert evaluation for ground truth in the traditional sense of clinical studies.

4. Adjudication Method for the Test Set:

This information is not applicable as the described testing is a bench-top mechanical fatigue test, not a clinical study involving human readers or interpretation requiring 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. The device is an endosseous dental implant abutment system, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical medical device (dental abutment system), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation in this context is based on mechanical endurance testing (fatigue strength) as defined by the ISO 14801:2007 standard.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This is not applicable for the same reason as above.

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Helioseal F Plus is used to seal fissures, pits and foramina caeca.

Helioseal® F Plus is a light-curing, white shaded fissure sealant featuring fluoride release. Helioseal F Plus is supplied in either a syringe or cavifil delivery form. The fissure sealant is composed of dimethacrylates. In the handling technique, the dental professional will clean the enamel surface to be sealed, isolate the working field, conditioning is performed, a thorough rinse and dry to remove the conditioner, before the application of Helioseal F Plus to the tooth surface.

This document is a 510(k) premarket notification for a dental device, specifically a pit and fissure sealant. It demonstrates substantial equivalence to a predicate device, rather than providing a performance study proving a device meets specific acceptance criteria as would be typical for an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes, expert involvement, ground truth establishment, and MRMC studies is not applicable to this document.

The document primarily focuses on demonstrating equivalence through:

• Comparison to Predicate Device: Detailed comparison of indications for use, contraindications, technology, principles of operation, and physical properties between Helioseal F Plus (subject device) and Helioseal F (predicate device).
• Bench Testing: Non-clinical performance testing for physical properties (flexural strength, curing depth, light intensity, wavelength for curing, water sorption, water solubility, radio-opacity) in accordance with FDA Guidance and EN ISO 6874:2015.
• Biocompatibility Testing: Evaluation for cytotoxicity and genotoxicity according to ISO 10993-1, ISO 7405, and ISO 14971.

The conclusion states that the devices are substantially equivalent, implying that the new device performs similarly to the already legally marketed predicate device. There are no acceptance criteria, in the sense of accuracy/recall/precision metrics for an AI/ML algorithm, or a human reader study, included in this type of submission.

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With its "Polywave" LED with broadband spectrum, Bluephase PowerCure is suitable for the polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

Bluephase® PowerCure is an LED curing light that produces blue light. It is used for the polymerization of light-curing dental materials immediately in the oral cavity of patients. The intended place of application is in the dental practice, medical practice or in the hospital by the dentist or dental assistant. The curing light must only be operated by trained dental personnel.

• The handpiece has the shape of a pen
• Operational notes: 4 programs (3s, Turbo, High, PreCure)
• Light source: Polywave LED
• Power Source: Li-lons batterv

Here's a breakdown of the acceptance criteria and study information for the Ivoclar Vivadent Bluephase PowerCure, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore some of the requested information (like expert readers, stand-alone performance, MRMC studies, or training set details) are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications, safety standards, and functional equivalence for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on "Reported Device Performance": For a 510(k) submission, "reported device performance" typically refers to how the new device matches or exceeds the performance characteristics of the predicate device, or meets relevant recognized standards. The summary indicates that the Bluephase PowerCure either has "no difference" or "conforms to the current version of the same standards" or offers an "innovation... with higher irradiance" but still achieves the same functional objective.

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

• Sample Size: Not explicitly stated for specific test sets in this summary document.
• Data Provenance: The document does not specify country of origin for testing data. The "study" itself is a comparison to a predicate device and adherence to recognized standards. It's a regulatory submission, not a clinical trial with a "test set" in the traditional sense of patient data. The testing mentioned pertains to engineering, electrical safety, software, and sterilization validation.

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

• Not Applicable. This is a dental curing light, not a diagnostic device requiring expert interpretation of results, nor does it involve a "ground truth" derived from expert consensus in a clinical context. The "truth" is established by adherence to technical specifications and recognized standards.

4. Adjudication Method for the Test Set

• Not Applicable. See explanation above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• Not Applicable. This device is an LED polymerization light and does not involve AI or human readers for diagnostic interpretation.

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

• Not Applicable. This device does not use an algorithm for diagnostic purposes. Its standalone performance is demonstrated by its physical and electrical specifications (e.g., light irradiance, wavelength, safety standards).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device's performance is established by:
  • Technical Specifications: Measuring the irradiance, wavelength, and other physical properties to ensure they meet the design specifications and are suitable for the intended use (polymerization of dental materials).
  • Compliance with Recognized Standards: Adherence to standards like IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility), and ISO 14937 (Sterilization).
  • Functional Equivalence: Demonstrating that the device performs the same function as the legally marketed predicate device (Bluephase Style 20i) and reference device (VALO Grand Corded) in polymerizing dental materials.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML device that requires a training set.

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

• Not Applicable. See explanation above.

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Conventional application (Light intensity ≤2,000 mW/cm2):

• Restorations in the posterior region (Class I and II, including the replacement of individual cusps)
• Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• Reconstructive build-ups
• Restoration of deciduous teeth
  Light-curing using the 3sCure mode of Bluephase® PowerCure (Light Intensity 3,050 mW/cm2):
• Restorations in the posterior region of permanent dentition (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect

Tetric® PowerFill is a light-curing radiopaque resin-based composite for the direct restorative treatment in posterior teeth. Tetric PowerFill cures with light in the wavelength range of 400-500 nm and can be applied in layers of up to 4 mm. The monomer matrix is composed of dimethacrylates (20-21 wt%). The fillers contain barium glass, ytterbium trifluoride, mixed oxide and copolymer (79-80 wt%). Additives, initiators, stabilizers and pigments are additional ingredients (

The provided text describes a 510(k) premarket notification for a dental restorative material called "Tetric® PowerFill." This document focuses on demonstrating that the new device (Tetric® PowerFill) is substantially equivalent to a legally marketed predicate device (Tetric EvoCeram Bulk Fill).

The acceptance criteria and study proving the device meets these criteria in the context of this document are related to bench testing of physical properties and biocompatibility, not a study involving human or AI readers or ground truth established by experts as would be common for diagnostic AI/ML devices.

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

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

The document states that "Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: flexural strength, curing depth, sensitivity to light, wavelength for curing, water sorption and water solubility and radiopacity according to ISO 4049:2009." It also mentions "The subject device was tested in direct comparison to the predicate device and the results of the bench testing show the products to be substantially equivalent."

It also states that "The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2009, ISO 7405:2008 and ISO 14971:2012. The following testing was conducted on the subject device: Cytotoxicity according to EN ISO 7405:2008 + A1:2013: ISO 10993-5:2009 and Genotoxicity according to EN ISO10993-3:2014 and the device was found to be non-cytotoxic and nongenotoxic."

While specific numerical acceptance criteria and performance data values are not explicitly provided in the text, the table below summarizes the types of criteria and the qualitative reported performance as stated.

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

This information is not provided in the given text as it pertains to a mechanical/chemical testing of a dental material, not a clinical study with a "test set" in the context of imaging or AI. The testing is described as "bench testing" and "evaluated based on a review of the literature."

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

This information is not applicable as the ground truth for physical and biocompatibility properties of a dental resin is established through standardized laboratory testing (e.g., ISO standards), not by human expert interpretation of images or other clinical data.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated above.

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

This information is not applicable as this document is for a dental restorative material, not an AI/ML diagnostic device that would involve human readers.

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

This information is not applicable as this document is for a dental restorative material, not an AI/ML algorithm.

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

The ground truth for the physical properties (flexural strength, curing depth, etc.) is established by standardized laboratory testing methods prescribed by ISO 4049:2009. For biocompatibility, the ground truth for cytotoxicity and genotoxicity is established by ISO 10993-5:2009 and EN ISO10993-3:2014 respectively, while other biocompatibility aspects (irritation, sensitization, systemic toxicity, implantation, pulp and dentin usage) were evaluated based on a review of scientific literature.

8. The sample size for the training set:

This information is not applicable as this document is for a dental restorative material undergoing physical and biocompatibility testing, not an AI/ML device requiring a training set.

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

This information is not applicable as this document is for a dental restorative material undergoing physical and biocompatibility testing, not an AI/ML device requiring a training set.

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Tetric® CAD is intended for:

• Veneers
• Inalys
• Onlays (e.g. occlusal veneers, partial crowns)
• Crowns in the anterior and posterior region

Tetric® CAD is a composite block for the fabrication of esthetic permanent inlays, onlays, veneers and crowns in the anterior and posterior region. Fabrication of the dental restoration is performed at the dentist's office in a compatible milling machine. The blocks are composed of cross-linked dimethacrylate and inorganic fillers. In the processing technique, the restoration is polished and seated after milling in the CAD/CAM system. The blocks are attached to a metal mandrel, the geometry of such is compatible with a milling machine, e.g. Cerec/InLab (Sirona), PlanMill (PlanMeca) or Programill One (Ivoclar Vivadent).

Tetric® CAD composite blocks are available in the translucency levels MT (5 shades - A1, A2, A3, A3.5, BL) and HT (4 shades 0 A1, A2, A3, A3.5), and in the sizes I12 and C14.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tetric® CAD device:

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for the new device's performance against specific clinical benchmarks. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical efficacy is not directly available in this type of submission. Instead, the focus is on showing similarity in functional performance and safety compared to an already approved device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence claim, the "acceptance criteria" are implicitly that the new device (Tetric® CAD) performs comparably or better than the predicate device (Cerasmart K133824) for the listed physical properties. The data presented are for comparison.

Note on Acceptance Criteria: For a 510(k), "acceptance criteria" mainly revolve around demonstrating the new device is as safe and effective as the predicate. For physical properties, this usually means meeting or exceeding the predicate's performance when tested under relevant standards. The document explicitly states "the results of the bench testing show the products to be substantially equivalent," meaning the Tetric® CAD met the implicit acceptance criterion of being comparable.

The subsequent points (2-9) are largely not applicable or not explicitly detailed in the provided 510(k) summary because this document focuses on bench testing and biocompatibility for material properties and substantial equivalence, rather than clinical efficacy studies with human subjects.

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 for test set: Not explicitly stated for specific tests like flexural strength or water solubility in the summary. For ISO standard compliance (like ISO 10477 and ISO 6872), specific sample sizes are prescribed by the standards, but these aren't given in this summary.
• Data provenance: Not specified in the summary. This would typically be from the manufacturer's R&D labs.
• Retrospective or prospective: Not applicable for bench (non-clinical) testing.

The following points (3-6) are typically relevant for clinical studies, which are not detailed in this 510(k) summary for Tetric® CAD, as the focus is on material properties and substantial equivalence through bench testing.

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 pertains to clinical studies often involving expert review of images or patient outcomes. The provided document details bench testing of material properties and biocompatibility, which does not involve establishing ground truth by human experts in this manner.

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

• Not Applicable. This is for clinical studies with human assessors.

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 type of study is typically for diagnostic AI devices, not for dental restorative materials like Tetric® CAD.

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

• Not Applicable. This refers to AI algorithm performance.

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

• For Flexural Strength and Water Solubility: The "ground truth" is established by the standardized measurement methods defined in ISO 6872:2015 and ISO 10477:2004, respectively.
• For Biocompatibility: The "ground truth" is determined by the results of specific in-vitro tests for cytotoxicity (EN ISO 7405:2008 + A1:2013; ISO 10993-5:2009) and genotoxicity (ISO 10993-3:2014), following the principles of ISO 10993-1:2009 + AC:2010.

8. The sample size for the training set

• Not Applicable. This is relevant for AI models. The document describes a material and its testing, not an AI system.

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

• Not Applicable. This is relevant for AI models.

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