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1. Direct restorative for Class I, II, III, IV, and V cavities
2. Fissure sealant
3. Sealing hypersensitive areas
4. Repair of (in)direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel
5. Blocking out undercuts
6. Liner or base
7. Core build-up
8. Adhesive cementation of ceramic and composite veneers, inlays and onlays with a thickness (

G-ænial Universal Injectable II is a light-cured, nano-filled radiopaque composite resin filled in syringe. The device is used for the restoration of both anterior and posterior teeth, core build-up, adhesive cementation of ceramic and composite veneer, inlays and onlays, and build-up for transparent removable orthodontic retainers. The device is available in 9 shades.

This document is an FDA 510(k) clearance letter for a dental resin material, G-ænial Universal Injectable II. It is important to note that this is NOT an AI/ML medical device submission. Therefore, the information provided in the document focuses on the material's physical and chemical properties and biocompatibility, as compared to predicate dental materials.

The request asks for information typically found in submissions for AI/ML medical devices, such as acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC), details about test and training sets, expert consensus for ground truth, MRMC studies, and effect sizes of AI assistance. Since this is a dental material, these types of studies are not relevant and are not present in the provided document.

Therefore, the following response will adapt the requested sections to the context of this dental material, explaining what information is available and what is not, given the nature of the device.

Acceptance Criteria and Device Performance for G-ænial Universal Injectable II

The acceptance criteria for G-ænial Universal Injectable II are based on established ISO standards for dental materials and FDA guidance for composite resin devices. The "study that proves the device meets the acceptance criteria" refers to the Performance Bench Tests and Non-Clinical Performance Testing detailed in Section 7 and 8 of the 510(k) summary. These tests assess the physical, chemical, and biological properties of the material.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Complies" with specific quantitative or qualitative thresholds defined by the standards (e.g., ISO 4049, ISO 6874). The document reports that the device Complies with all listed requirements.

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

For a dental material, the "test set" refers to the samples of the material manufactured and subjected to the performance bench tests and biocompatibility assessments.

• Sample Size: The document does not specify the exact number of samples (e.g., number of specimens for flexural strength, number of animals for biocompatibility tests). It simply states that "Performance testing includes" and "A biocompatibility assessment was completed."
• Data Provenance: The data provenance is internal to the manufacturer (GC America, Inc.) and derived from laboratory testing of the material according to international ISO standards and FDA guidance documents. There is no indication of "country of origin of the data" in the sense of patient data, nor is it a retrospective or prospective study in the clinical trial sense. These are laboratory-based material characterization tests.

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

This question is not applicable to a dental material submission. The "ground truth" for material properties is established by the standardized test methods themselves (e.g., ISO 4049 defines how depth of cure is measured). There are no "experts" establishing ground truth in the sense of clinical interpretations or diagnoses. The expertise lies in adhering to the established test protocols and analyzing results accurately by qualified laboratory personnel.

4. Adjudication Method for the Test Set

This concept is not applicable for dental material performance testing. Adjudication methods (like 2+1, 3+1 consensus) are used in studies involving human interpretation of images or clinical outcomes, typically for AI/ML device validation. Here, tests are quantitative measurements of physical/chemical properties or biological responses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improving with AI vs Without AI Assistance

This question is not applicable. G-ænial Universal Injectable II is a dental restorative material, not an AI-assisted diagnostic or therapeutic device. There are no "human readers" involved in interpreting its performance, nor does it assist human readers. Therefore, no MRMC study was performed, and no effect size on human reader improvement with AI assistance can be reported.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable. G-ænial Universal Injectable II is a physical dental material, not an algorithm. There is no "standalone performance" of an algorithm. Its performance is measured directly through laboratory tests of its inherent material properties.

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

For dental materials, the "ground truth" is based on:

• Standardized Test Methods: Adherence to established ISO standards (e.g., ISO 4049, ISO 6874, ISO 10993) defines the "truth" for material properties like flexural strength, depth of cure, water sorption, and biocompatibility.
• Predicate Device Comparison: Performance is also evaluated in comparison to predicate devices, where "equivalence" often serves as a benchmark for acceptance.

There is no "expert consensus," "pathology," or "outcomes data" in the sense of human diagnostic performance or clinical trial results, as this is a pre-market notification for a material.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" for a dental material in the context of machine learning. The material itself is manufactured, and specific properties are tested for quality control and regulatory submission.

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

This question is not applicable, as there is no training set.

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1. Furcation or root perforation treatment via canal
2. Furcation or root perforation treatment via surgical
3. Internal reabsorption treatment via canal or surgical
4. External reabsorption treatment
5. Retrofilling in parendodontic surgery
6. Direct and Indirect pulp capping
7. Apexification
8. Apexogenesis and Pulpotomy

One-Fil Putty Injectable is a premixed material intended for permanent root canal filling. It is based on a tricalcium silicate composition, which undergoes setting and hardening in the presence of moisture.
The product is packaged in a paper box with four syringes in a vinyl packaging, and the contents in the glass syringe are white paste type.

This FDA 510(k) clearance letter and summary are for a dental material, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, ground truth establishment, training set details, and expert qualifications) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study proving it meets them.

Acceptance Criteria and Device Performance for One-Fil Putty Injectable (K251884)

The "One-Fil Putty Injectable" is a dental root canal filling material. Its acceptance criteria are based on conformance to international standards for dental materials, specifically ISO 6876, and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by conformance to ISO 6876 and the performance of the predicate device (One-Fil Putty, K243353). The reported performance of the subject device is directly compared to the predicate device in the 510(k) summary.

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• Temporary inlay and onlay treatments of the cavity.
• Sealing of openings for implant screws.
• Relining material for temporary crowns and bridges.
• Covering of the gingival margin
• Fixing of resin matrix during filling placement.
• Block-out material for retentive ares in the dental arch, e.g. before taking impressions.

Once-Fil Flow is a light-curing filling material designed for temporary restorations. It serves as an interim solution before the placement of a final prosthesis, providing functions such as pulp protection and maintaining tooth position. The material is suitable for temporary fillings in prepared cavities and inlay/onlay cases.

To accommodate different clinical needs, Once-Fil Flow is available in two shades. The Yellow shade is ideal for anterior teeth, where esthetics are a priority, while the Blue shade provides clear visual contrast, making it easier to identify and remove before permanent restoration.

The application process involves preparing the tooth surface, applying an appropriate amount of material, and light-curing it. Once cured, the material can be finished and polished using conventional instruments.

The provided FDA 510(k) clearance letter and summary for "Once-Fil Flow" does not describe an AI medical device or an AI/ML software. Instead, it pertains to a dental resin material. Therefore, the request to describe the acceptance criteria and study proving the device meets those criteria for an AI device cannot be fulfilled from the provided text.

The information in the provided text focuses on the material characteristics and biocompatibility of a dental flowable resin. The regulatory context described is for a Class II medical device, product code EBF (Tooth Shade Resin Material), regulated under 21 CFR 872.3690.

The document highlights the basis for substantial equivalence to a predicate device (Clip Flow by VOCO GmbH, K153493) through:

• Identical Indications for Use: Temporary inlay/onlay, sealing implant screw openings, relining temporary crowns/bridges, covering gingival margin, fixing resin matrix, and block-out material.
• Similar Technological Characteristics: Light curing type, similar materials (with minor differences confirmed by performance and biocompatibility), same intended user, similar delivery method, same period of use and shelf-life.
• Performance Testing (Non-Clinical): Appearance, Weight, Packaging, Sensitivity to Ambient Light, Curing Depth, Water Sorption/Solubility, Color and Color Stability, and Shore D Hardness, all tested in accordance with ISO 4049 and ISO 868.
• Biocompatibility Testing: ISO 10993 series tests including cytotoxicity, irritation, systemic toxicity, and skin sensitization.

No information regarding AI, machine learning, clinical image analysis, or human reader studies is present in the provided text. The request for details on sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone AI performance, ground truth types, and training set information is not applicable to this specific device (a dental resin material) based on the supplied documentation.

Therefore, since the input document describes a physical dental material and not an AI/ML medical device, I cannot extract the requested information regarding AI acceptance criteria and study details.

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• Direct restorations
• Base and Liner
• Block out undercut
• Repair of (in)direct aesthetic restorations
• Core build-up

EsFlow PLUS is a light-cured radiopaque flowable composite resin used for direct restoration. It has a smooth surface, so it is applied smoothly to the teeth, and has good gloss and aesthetics. In addition, it has high mechanical strength, so it can sufficiently withstand the occlusal force. EsFlow PLUS has two types of viscosities, so it can be applied to various clinical cases. The inorganic filler of EsFlow PLUS has a particle size range of 0.01 to 0.5 μm, and a volume ratio of about 42 to 47% depending on the model.

I apologize, but the provided text from the FDA 510(k) Clearance Letter for "EsFlow PLUS" does not contain the information requested about acceptance criteria and the study proving the device meets those criteria, especially not in the context of an AI/ML medical device.

The document is for a "Tooth Shade Resin Material" (a dental composite material), which is a physical material, not an AI/ML software device. The clinical studies mentioned (depth of cure, flexural strength, compressive strength) are material performance tests, comparing the new dental resin to a legally marketed predicate dental resin, and ensuring both meet ISO standards.

Therefore, I cannot extract the following information from the provided text as it is not present for this type of device and study:

• A table of acceptance criteria and the reported device performance (for an AI/ML device)
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on the physical and mechanical properties of a dental composite material, comparing it to an existing material to demonstrate substantial equivalence, as required for a 510(k) clearance for this type of Class II device.

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• Anterior and posterior restorations
• Repair of restorations and prostheses
• Core-build up
• Direct laminate veneer

Not Found

The provided text is a standard FDA 510(k) clearance letter for a dental resin material, "Beautifil II." This document confirms that the device has been cleared for marketing based on its substantial equivalence to previously marketed devices.

*Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-based medical device. The product, "Beautifil II," is a physical dental material (tooth shade resin), not an AI/ML software device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance
• Sample sizes for test sets or data provenance
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• MRMC study details or effect sizes
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size or how its ground truth was established

The 510(k) clearance process for a material like Beautifil II typically involves different types of testing (e.g., biocompatibility, physical properties, mechanical strength, chemical composition) to demonstrate safety and effectiveness, rather than a clinical study with image-based ground truth and human reader performance evaluation as would be done for an AI/ML diagnostic aid.

If you have a document describing the testing for an AI/ML device, please provide that, and I would be happy to analyze it against your request.

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Sil-Flow is indicated for
[A] Temporary inlay and onlay treatments of the cavity
[B] Sealing of openings for implant screws
[C] Relining material for temporary crowns and bridges
[D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions
[E] Covering of the gingival margin
[F] Fixing of resin matrix during filling placement
[G] Temporary filling of cavities

Sil-Flow is a flowable light-cured temporary filling material used for filling and sealing.

The provided FDA Premarket Notification (510(k)) for the Sil-Flow device is for a Tooth Shade Resin Material and NOT an AI/Software as a Medical Device (SaMD) product. Therefore, the information typically found in such a submission regarding AI device performance, such as:

• Acceptance Criteria for AI performance metrics (e.g., sensitivity, specificity, AUC)
• Study design for AI performance evaluation (e.g., standalone, human-in-the-loop, MRMC)
• Sample size and data provenance for AI test sets
• Ground truth establishment (number/qualifications of experts, adjudication methods)
• Training set details for AI models
• Effect size of AI assistance for human readers

are not present in this document.

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Clip Flow) based on physical and chemical properties, biocompatibility, and intended use for a dental material.

Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is absent from the perspective of an AI/SaMD device:

Acceptance Criteria and Study Proving Device Meets Criteria (for Dental Material)

The acceptance criteria and supporting study for Sil-Flow relate to its physical, chemical, and biological properties as a tooth shade resin material, demonstrating its safety and performance for its indicated uses.

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

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• class I to V restorations
• reconstruction of traumatically damaged anteriors
• facetting of discolored anteriors
• correction of shape and shade for improved aesthetic appearance
• locking, splinting of loose teeth
• repairing veneers
• restoration of deciduous teeth
• core-build-up under crowns
• composite inlays

Not Found

The provided FDA 510(k) Clearance Letter for "GrandioSO Unlimited" indicates that the device has been cleared as a "Tooth Shade Resin Material" (Product Code: EBF). This means it is a dental filling material, and the information provided in the document pertains to its substantial equivalence to predicate devices, its intended uses, and regulatory compliance.

Crucially, this document is a regulatory clearance for a physical dental material, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/SaMD performance (e.g., accuracy, sensitivity, specificity for diagnostic or assistive AI) are not applicable to this specific dental material clearance letter.

The clearance for a dental material like GrandioSO Unlimited is based on demonstrating substantial equivalence to a legally marketed predicate device, typically through:

• Material properties testing: Demonstrating that the physical, chemical, and mechanical properties (e.g., flexural strength, wear resistance, color stability, biocompatibility) are comparable to the predicate device.
• Biocompatibility testing: Ensuring the material is safe for use in the body.
• Clinical use claims: Showing that the material can be used for the stated indications (e.g., Class I to V restorations) effectively and safely, often supported by existing literature or non-clinical data if the material formulation is similar to established products.

Therefore, I cannot extract the requested information (1-9) from the provided text because these elements are specific to the validation of AI/SaMD performance, not the regulatory clearance of a dental restorative material.

The document states:

• Device Name: GrandioSO Unlimited
• Regulation Name: Tooth Shade Resin Material
• Product Code: EBF
• Indications for Use: Class I to V restorations, reconstruction of traumatically damaged anteriors, facetting of discolored anteriors, correction of shape and shade for improved aesthetic appearance, locking, splinting of loose teeth, repairing veneers, restoration of deciduous teeth, core-build-up under crowns, composite inlays.

These are typical uses for a dental composite material. The "study" proving it meets "acceptance criteria" would be a battery of standard dental material tests and biocompatibility assessments, demonstrating its equivalence to existing, legally marketed tooth shade resin materials. This letter does not contain the specifics of those material tests or any AI/SaMD-related performance metrics.

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Reon is a 3D printing resin used in dentistry for the fabrication of both temporary and permanent dental restorations, specifically crowns, bridges, inlays, onlays, and veneers.

Reon is a photopolymerizable, methacrylate-based composite resin used in dental CAD/CAM technology for the fabrication of dental prostheses. This resin is specifically designed for both temporary and permanent dental restorations, such as crowns, bridges, inlays, onlays, and veneers, utilizing 3D printing processes.

Reon is a light-curing methacrylate-based polymer resin used in the production of dental restorations through CAD/CAM technology at dental clinics. This resin is suitable for the 3D printing process of temporary and permanent dental restorations, especially crowns, bridges, inlays, onlays, and veneers.

Reon is made from a methacrylate-based resin and is stored in liquid form in Aluminum 1050A or 1070A bottles, with two different volumes (500 g/1,000 g) for each shade. To support a variety of shades, it offers four different options: Clear, A1, A2 and A3. This resin is cured using a UV (ultraviolet) laser with a wavelength of 405nm, activated by a specific photoinitiator at 405nm.

Reon is suitable for creating custom dental restorations using UV-curing 3D printers. It can be used under the following printing and curing conditions:

• Layer Thickness: 50 μm
• Resolution: X, Y axis resolution of 40-90 μm
• Printing Process: Compatible with DLP (Digital Light Processing) based 3D printers
• Post-Curing: Final polymerization is completed by additional UV curing after printing

Reon is compatible with UV-curing 3D printers and is primarily used with the following devices:

• 3D Printer: DLP-based 3D printers
• Software: CAD files (.stl) generated from dental software for printing
• Scanner Compatibility: Intraoral Scanner and 3D design software (e.g., 3Shape)

The clinical workflow for Reon is as follows:

1. The dentist uses an intraoral scanner to scan the patient's mouth and create a CAD file.
2. Based on the scan data, the restoration is designed using software.
3. The designed STL file is used to print custom crowns, bridges, etc., with a 3D printer.
4. The printed restoration undergoes additional UV curing in a post-curing device to complete the hardening process.
5. The final restoration is then trimmed and polished to fit the patient's teeth before being provided to the patient.

Reon has passed biocompatibility testing and meets the necessary physical, chemical, and mechanical properties, making it suitable for use in dental restorations.

Please note that this product must be used in conjunction with a scanner, design software, and a 3D printer, which are not included with the product. Additionally, to achieve optimal performance, the UV curing process after printing is essential.

The provided text describes a 510(k) clearance for "Reon Dental Resin," a 3D printing resin for dental restorations. The information below focuses on the acceptance criteria and the study used to demonstrate substantial equivalence, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance:

The device's performance was evaluated against the standards outlined in ISO 10477:2020, "Dentistry – Polymer-based crown and veneering materials." The reported performance of the Reon device is compared to these acceptance criteria and the predicate device (Tera Harz II).

Table: Acceptance Criteria and Reported Device Performance for Reon Dental Resin

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

The document does not explicitly state the sample size for the test set used for performance testing (Depth of Cure, Flexural Strength, Water Sorption, Solubility, Shade Consistency, Color Stability). However, it mentions that for "Manufacturing Validation," "the evaluation criteria of all the specimens were more than 50 MPa," implying multiple specimens were tested. The provenance of this data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory testing conducted by the manufacturer, C.E.I.B.med.

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

This information is not applicable and not provided in the document. The "ground truth" for material performance studies like those described (e.g., flexural strength in MPa, water sorption in μg/mm³) is established through standardized laboratory testing methods and measurements, not through expert consensus on qualitative observations.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., image reading) where multiple experts assess the same case and discrepancies need resolution. For physical and chemical property tests of a dental resin, objective measurements are taken, and adjudication by experts is not a standard practice.

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

No MRMC comparative effectiveness study was done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure the impact of AI on reader performance. The Reon device is a dental resin, not an AI software, and therefore such a study is not relevant.

6. Standalone (Algorithm Only) Performance:

No standalone (algorithm-only) performance was done. As Reon is a material (dental resin) and not an algorithm/software, this concept does not apply. The performance evaluated was the physical and chemical properties of the material itself.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing of the Reon dental resin was established through standardized laboratory testing and objective measurements against established material standards (specifically ISO 10477:2020). For example, Flexural Strength is measured by breaking specimens and calculating force per unit area, and Water Sorption is determined by measuring weight changes of specimens after water immersion.

8. Sample Size for the Training Set:

This information is not applicable and not provided in the document. Training sets are relevant for machine learning algorithms. Reon is a physical material, and its development and validation process would involve formulation, experimental testing, and optimization, not a "training set" in the context of AI.

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

This information is not applicable as there is no "training set" for a dental resin product in the AI context. The development of the resin would involve scientific and engineering principles, quality control, and adherence to established material science methodologies.

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Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-cured resin indicated for the fabrication of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges.

Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-curing, hybrid dental material, composed of methacrylic acid esters, inorganic filler, photoinitiator, organic pigments, inorganic pigments and additives. It is Liquid resin for dental 3D printing of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. For use in Digital Light Processing (DLP)- 3D printers utilizing wavelengths at 385nm or 405nm.

The Subject device is packaged in black plastic bottles made of high density polyethylene (HDPE) according to the weight of the resin liquid.

There are different shades A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, BL1, BL2, BL3, BL4, and the different shades are reflected in the different colors of finished restorations.

The provided FDA 510(k) clearance letter and summary describe a dental resin, not an AI/software as a medical device (SaMD). Therefore, the information required for explaining AI/SaMD acceptance criteria and studies (such as diagnostic performance metrics, reader studies, ground truth establishment, training/test set details, etc.) is not present in this document.

The document focuses on the physical, mechanical, and biocompatibility properties of a dental manufacturing resin. As such, I cannot extract the requested information regarding AI/SaMD performance studies from this provided text.

Here's a breakdown of why the requested information cannot be provided based on the input:

• Device Type: The device, "Additive Manufacturing (Light Curing) Crown Bridge Resin," is a material used for 3D printing dental restorations. It is not an AI algorithm or software.
• Study Type: The studies performed are bench tests (Non-clinical Test Conclusion) evaluating material properties (e.g., flexural strength, water sorption, biocompatibility) against established ISO standards, and shelf-life testing. These are not studies to prove the performance of an AI model.
• Acceptance Criteria & Performance: The acceptance criteria are explicitly tied to physical and mechanical properties (e.g., Flexural Strength ≥ 50 MPa as per ISO 10477:2020), not diagnostic accuracy or other AI-related metrics.
• Missing Information Related to AI/SaMD: All specific points requested in your prompt (sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, effect size) are entirely absent because they are not applicable to the clearance of a dental resin material.

In summary, the provided document does not contain the information necessary to describe the acceptance criteria and study that proves an AI/SaMD device meets its acceptance criteria. The document pertains to a physical dental material, not an artificial intelligence product.

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• Anterior and posterior restorations.
• Indirect restorations for Inlays, onlays and veneers.

Any-Com Flow is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth.
The product offers a wide range of options with a total of 9 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and darkness that match the patient's natural teeth.
After the appropriate tooth pretreatment process for the selected shade, Any-Com Flow is applied to the teeth using enclosed tip and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.

This document is a 510(k) clearance letter for a dental composite resin called "Any-Com Flow". It establishes substantial equivalence to a predicate device, "Any-Com". The information provided primarily focuses on the device's technical specifications and a comparison to its predicate, rather than a clinical study evaluating its real-world performance against specific acceptance criteria in a human population.

Therefore, it is impossible to fully answer all aspects of your request as this document does not contain information about:

• A study that proves the device meets specific acceptance criteria in a clinical setting with human subjects.
• Clinical test set sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, or specific efficacy criteria that would be relevant for devices that provide diagnostic or prognostic outputs.
• Training set sample sizes or how their ground truth was established, as this is not an AI/ML device relying on such training.

However, I can extract the acceptance criteria and reported performance based on the non-clinical testing conducted to demonstrate substantial equivalence, which is the focus of this 510(k) application. This non-clinical testing adheres to international standards (ISO 4049 and ISO 10993).

Here's the information extracted and formatted to answer your request as much as possible given the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document states that the performance tests were conducted "in accordance with ISO 4049" and biocompatibility tests "in accordance with ISO 10993." For a 510(k) submission, the "acceptance criteria" are implied to be that the device successfully meets all relevant requirements and limits defined by these international standards for dental restorative materials and biocompatibility, respectively, and that its performance is substantially equivalent to the predicate device. The exact numerical limits from the ISO standards are not provided in this 510(k) summary.

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

• Sample Size: The document does not specify the exact sample sizes used for each non-clinical performance test (e.g., how many specimens were tested for flexural strength). These details would typically be found in the full test reports referenced in the submission, not the summary.
• Data Provenance: The tests were conducted by MEDICLUS Co., Ltd., which is based in the Republic of Korea. The testing is non-clinical (laboratory-based) rather than patient-derived data, so there is no "country of origin of the data" in the sense of patient demographics. The tests are "retrospective" in the sense that they were conducted for this specific 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. The "test set" here refers to physical samples of the dental material, and the "ground truth" is established by direct measurement against known ISO standards and methods, not by expert consensus (e.g., no radiologists or other medical professionals are involved in interpreting results for material properties like flexural strength).

4. Adjudication method for the test set

• This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for interpreting complex clinical data or images by multiple experts. For material property testing, results are quantitative measurements against an established standard, not subjective interpretations 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening devices that assist human readers (e.g., radiologists interpreting images). Any-Com Flow is a dental restorative material, not an AI device.

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

• No, a standalone algorithm performance study was not done. Any-Com Flow is not an algorithm or an AI device. The "performance" refers to the physical and chemical properties of the material itself.

7. The type of ground truth used

• The "ground truth" for the non-clinical performance tests is based on direct physical and chemical measurements against the specified methodologies and requirements of ISO 4049 (for dental polymer-based restorative materials) and ISO 10993 (for biological evaluation of medical devices). This is akin to established scientific and engineering standards for material properties.

8. The sample size for the training set

• This information is not applicable. Any-Com Flow is a dental material, not a machine learning model. Therefore, there is no "training set."

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

• This information is not applicable, as there is no training set for this device.

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