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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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Ormco™ EtchFree Bonding Primer is a bonding primer intended to bond orthodontic appliances such as metal brackets, ceramic brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement without etching.

Ormco™ EtchFree Adhesive is a light-curing adhesive that is intended to be used for the attachment of orthodontic appliances to teeth such as metal bracket, ceramic brackets, and aligner attachments.

The Ormco™ Bonding System consists of a primer, a sealant, an adhesive, and bonding accessories.

· Ormco™ Bonding Primer is intended to bond orthodontic appliances such as metal brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement. The primer is a clear liquid that conditions the surface of the application of a bonding sealant/enhancer. Ormco Bonding Primer is designed to be used as a system along with Ortho Solo and Ormco" Bonding Adhesive. The primer is offered in single-use vials which will be sold in kits and separately.

· Ormco™ Adhesive is a light-curing composite that is intended to be used with metal and ceramic brackets for orthodontic treatment and can also be used as aligner attachment. It is a convenient off-white paste providing aesthetics when used as aligner attachments or beneath a bracket. The adhesive is designed to be used as a system along with Ormco Bonding Primer and Ortho Solo. The adhesive is offered in syringes for multi-patient use, which will be sold in kits and separately.

This document describes the Ormco™ EtchFree Bonding System, comprising the Ormco™ EtchFree Bonding Primer and Ormco™ EtchFree Adhesive, and its substantial equivalence to predicate devices. The information provided focuses on non-clinical performance bench testing rather than clinical studies related to human reader performance or detailed AI-specific metrics.

Here's an analysis of the provided text in relation to your questions:

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

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance values. It lists the international and FDA-recognized consensus standards against which non-clinical performance bench testing was conducted. It generally states that "All results were deemed acceptable."

However, based on the mentioned tests, we can infer the areas of performance evaluated:

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

The document primarily discusses non-clinical performance bench testing. It does not mention clinical studies or human test sets. Therefore, details regarding sample size for test sets, country of origin, or retrospective/prospective data are not applicable in this context. The "test set" refers to materials or samples used in laboratory bench tests. The specific number of samples for each bench test (e.g., how many specimens for shear bond strength) is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical bench testing of a dental adhesive system. There is no mention of experts or ground truth establishment in the context of human assessment or interpretation of results for a test set. The "ground truth" for these tests would be the measurement results against established scientific standards.

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

This is not applicable as there is no mention of a human-centric test set requiring adjudication in the provided text.

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 described is a dental adhesive system, not an AI-powered diagnostic tool or image analysis system. There is no mention of AI assistance or human reader studies.

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 dental product, not an algorithm.

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

For the non-clinical bench tests, the ground truth is established by the scientific and engineering principles and methodologies outlined in the referenced international and FDA-recognized consensus standards (e.g., ISO 29022 for shear bond strength, ISO 11405 for adhesion, ISO 10993 series for biocompatibility). The "truth" is whether the material properties or biological responses meet the specifications or thresholds defined by these validated tests.

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI model or algorithm 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 (physical product, not AI).

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BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel.

BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

American Orthodontics' BracePaste Fluoride Sealant is a light-curing primer that is intended for use in orthodontic treatment as diagnosed by a trained dental professional or orthodontist. The primer prepares the enamel during orthodontic treatment to increase adhesion to the bonding surface by wetting the bonding surface of the object to be bonded.

The provided document describes the FDA 510(k) clearance for the BracePaste Fluoride Sealant. It is a submission for a dental device, specifically a light-cure primer/sealant for orthodontic bonding. As such, it does not involve AI/ML technology or image processing. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

The acceptance criteria and study information provided in the document are primarily for demonstrating substantial equivalence to a predicate device (Opal Seal) through non-clinical performance and biocompatibility testing.

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

The document does not explicitly present a table of acceptance criteria with numerical targets for each performance test. Instead, it states that "Results of all conducted testing was found acceptable and does not raise any new issues of safety or effectiveness." and "Results of bench testing indicate that BracePaste Fluoride Sealant performs as well as the predicate Opal Seal." This implies that the acceptance criteria are met if the new device's performance is comparable to or performs as well as the predicate device or meets established standards (e.g., ISO 29022:2013 for Shear Bond Strength).

However, based on the non-clinical performance tests listed, here's a conceptual table:

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

The document does not specify the exact sample sizes for each non-clinical test conducted (e.g., how many samples were tested for Shear Bond Strength). It only lists the types of tests.

Given the nature of the device and studies (non-clinical bench testing), data provenance typically refers to the testing being performed in an accredited lab, often in the country of the manufacturer. However, this specific detail (country of origin for the data) is not provided in the document. All testing described is prospective, as it was conducted specifically for this submission.

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 a non-clinical bench testing submission for a dental material, not an AI/ML device requiring expert ground truth for interpretation.

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

Not applicable. This is a non-clinical bench testing submission for a dental material.

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

Not applicable. This is a non-clinical bench testing submission for a dental material, not an AI-assisted diagnostic or treatment planning device.

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

Not applicable. This is a non-clinical bench testing submission for a dental material, not an algorithm.

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

The "ground truth" for non-clinical performance testing typically refers to:

• Established physical and chemical standards: For tests like depth of cure, water sorption, water solubility, and fluoride measurements, the ground truth is often defined by industry standards or specifications for dental materials.
• Predicate device performance: For comparative tests like shear bond strength, the "ground truth" or benchmark is the performance of the legally marketed predicate device (Opal Seal).
• Biocompatibility standards: For biocompatibility, the ground truth is defined by international standards like ISO 10993 series and ISO 7405, which specify acceptable limits for various biological responses.

8. The sample size for the training set

Not applicable. This is a non-clinical bench testing submission for a dental material; there is no "training set" as it does not involve AI/ML.

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

Not applicable. There is no training set for this type of device submission.

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3M Transbond Orthodontic Adhesive is indicated for the following uses:

• · Creating attachments for orthodontic tray aliqners.
• · Bonding orthodontic brackets to teeth.

3M Transbond Orthodontic Adhesive is a thixotropic, visible-light activated, radiopaque orthodontic adhesive. The product is stored in a multi-use syringe which is used with single-use dispensing tips.
3M Transbond Orthodontic Adhesive contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20 nm silica filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).

This document is a 510(k) Premarket Notification for a dental adhesive, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and study designs typically associated with AI/ML device performance (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) is not available in the provided text.

The document discusses the substantial equivalence of the 3M™ Transbond™ Orthodontic Adhesive to legally marketed predicate devices. The acceptance criteria and testing described pertain to the physical and chemical properties of the adhesive.

Here's a breakdown of the relevant information provided:

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

The document mentions the following performance parameters were tested:

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

• Sample Size: Not specified in this 510(k) summary. These details would typically be found in the full test reports, which are not included in this document.
• Data Provenance: Not specified. These are bench studies, not patient data studies, so geographical origin or retrospective/prospective nature isn't typically relevant in the same way it would be for clinical AI/ML studies.

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 a material science and engineering evaluation, not an AI/ML medical imaging device requiring human expert consensus for ground truth. The "ground truth" for these tests are objective measurements based on established dental material testing standards (e.g., ISO 4049).

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

• Not applicable. This is not an AI/ML device requiring human adjudication of results.

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

• Not applicable. This is a dental adhesive, 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 a physical device, not an algorithm. The "performance" is inherent to the material itself, measured in laboratory settings without human interpretation assistance in the way an AI would be.

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

• The "ground truth" for the performance tests (Shear Bond Strength, Depth of Cure, Three-Body Wear Resistance, Rheology) would be the objective measurements derived from standardized laboratory testing methods against established mechanical and chemical benchmarks for dental adhesives. This is not subjective expert consensus or patient outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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• Retention of aligners e.g. by fabrication of aligner attachments
• Bonding of lingual retainers
• Occlusal build-ups

Not Found

The provided text is an FDA 510(k) clearance letter for the AlignerFlow LC device. It indicates that the device has been found substantially equivalent to predicate devices for its stated indications for use (retention of aligners, bonding of lingual retainers, and occlusal build-ups).

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies. The letter is a regulatory clearance document, not a clinical study report or a technical performance evaluation.

Therefore, I cannot provide the requested table and study details based on the input text.

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TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface.

TP Orthodontics Pre-Applied Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.

TP Orthodontics Echant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive are light cure orthodontic adhesive used for bonding the orthodontic brackets, molar tubes, and buccal tubes to the surface of teeth for orthodontic treatment. The variations available are:

• . TP Orthodontics Light Cure Adhesive System, which consists of an adhesive paste (will be available in a pre-loaded syringe), and sealant.
• . TP Orthodontics Pre-Applied Adhesive, consisting of bracket adhesive pre-applied to the bracket pad.

The adhesives prevent bracket drift during placement, and is easy to clean-up excess (flash') prior to curing. The adhesive is polymerized ('cured') by exposure to a dental curing light, and once cured it creates a bond, attaching the orthodontic appliance to the teeth.

TP Orthodontics Etchant is a phosphoric acid etchant used on tooth enamel or dentin in preparation for orthodontic bonding. It is a blue gel and will be contained in a syringe, which will use disposable dispensing tips for its controlled application.

The provided text is a 510(k) summary for dental adhesive products and an etchant, not an AI/ML medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information for an AI/ML device.

The document explicitly states:

• "No clinical performance testing was conducted on TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, and TP Orthodontics Etchant."
• "TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive and TP Orthodontics Etchant bench testing was performed. The proposed device passed testing and performed similar to its predicate devices (test reports are attached to this submission)."

This means the submission relies on bench testing demonstrating similarity to predicate devices, rather than clinical studies or AI/ML performance evaluations.

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FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.

The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.

The provided text describes the 510(k) summary for the FiteBac® CC OrthoSeal device. Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format for the device's performance characteristics. Instead, it categorizes performance testing, and the reported performance is described as being "acceptable" and not raising "any new issues of safety or effectiveness" in comparison to predicate devices. The primary performance characteristic mentioned is "Bond Strength Testing."

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A light cure orthodontic band cement intended to bond orthodontic bands to teeth.

American Orthodontics' BracePaste Band and Build LC is a light-cure band cement that is intended to bond orthodontic bands to teeth.

When an orthodontic band is required for orthodontic treatment, band cement is applied to the inside of the orthodontic band and then the band is seated onto the tooth. Once the band is seated properly, excess adhesive is cleaned up from the proximity of the band and tooth and the adhesive is cured via curing light. The polymerization of the adhesive forms a bond between the orthodontic band and / or the tooth enamel. Upon completion of orthodontic treatment, the orthodontic band is removed and any adhesive remaining on tooth enamel is cleaned up and removed from the tooth.

The provided document describes the 510(k) submission for "BracePaste Band and Build LC," an orthodontic band cement. The document states that no clinical performance testing has been conducted. The submission relies on non-clinical performance testing and a comparison to a predicate device to establish substantial equivalence.

Therefore, the following information regarding acceptance criteria, study details, and ground truth cannot be extracted as they are not present in the provided text.

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

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

• Sample Size (Test Set): Not applicable (no clinical testing).
• Data Provenance: Not applicable (no clinical testing).

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

• Not applicable (no clinical testing).

4. Adjudication method for the test set:

• Not applicable (no clinical testing).

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

• No MRMC study was done. This device is an orthodontic band cement, not an AI device for diagnostic reading.

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

• Not applicable, as this is not an AI algorithm.

7. The type of ground truth used:

• Not applicable (no clinical testing). For non-clinical testing, relevant benchmarks were likely derived from material science standards.

8. The sample size for the training set:

• Not applicable (no machine learning model to train).

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

• Not applicable (no machine learning model to train).

Non-Clinical Performance Testing Details (as provided):

The document states that the following non-clinical performance tests were conducted:

• Shear Bond Strength Test (ISO 29022:2013)
• Accelerated Aging Stability Test
• Interaction with Accessories

The conclusion states that the "combination of in-house testing and side-by-side comparison performed by the original manufacturer has demonstrated the efficacy or suitability to the intended purpose of the BracePaste Band and Build LC." It also states, "Results of bench testing indicate that BracePaste Band and Build LC performs as well as the predicate Light-Cured Orthodontic Band Cement." However, specific numerical acceptance criteria or reported performance values for these tests are not provided in the document.

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Orthocem: Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface.
Ortho bite: The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment.

Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product's removal from teeth, after removing brackets.
Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. Its composition includes dimethacrylate monomers, HEMA Phosphate, traditional Camphorquinone/DABE system as photoinitiator and silica as load particle. The combination of silica load fillers with the dimethacrylate monomer composition results in a viscosity that allows it to be handled and applied without running off the application area. The presence of HEMA Phosphate allows adhesion to the enamel surface, which is a known feature of composite cements indicated for bracket bonding. The thixotropy allows the product to have self-levelling capability, known as a shear thinning property that makes the composite settle correctly on the occlusal surface. The product is colored in order to facilitate its identification during application and removal.

The provided document is a 510(k) Premarket Notification from the FDA for two dental adhesive devices, "Orthocem" and "Ortho Bite". It details the equivalence to predicate devices based on non-clinical testing of material properties, not a study involving AI or human readers for diagnostic performance. Therefore, many of the questions related to AI-specific evaluation metrics, human expert involvement, and clinical study design (like MRMC, effect size, training/test sets for AI, and adjudication) are not applicable to this submission.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based only on the information available in the provided text:

Key Takeaway: This 510(k) submission focuses on demonstrating substantial equivalence of dental materials based on physical, chemical, and mechanical properties, not on AI-driven diagnostic performance or human reader studies. The "study" mentioned refers to non-clinical laboratory tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally derived from recognized international standards like ISO 4049, ISO 10993, and ISO 29022. The reported device performance is compared against these standards.

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

• Sample Size: The document does not specify the numerical sample sizes for each non-clinical test (e.g., how many specimens were used for flexural strength tests). It refers to the tests performed "according to the table below" for performance studies.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured product samples, not on patient data. The manufacturer, DENTSCARE LTDA, is based in Brazil (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL). The tests generated prospective data (i.e., designed experiments to evaluate product properties).

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

• This is not applicable as the "test set" consists of non-clinical material samples, not patient data requiring expert interpretation (e.g., radiology images). The ground truth is established by the physical and chemical properties of the materials themselves, measured by standardized laboratory methods.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., radiologist reads) in clinical studies. For physical material tests, results are objectively measured.

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 submission is for dental adhesive materials, not an AI-assisted diagnostic device. No MRMC study was performed, and human reader performance with or without AI assistance is not relevant to this device's evaluation.

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

• Not applicable. This device is a material, not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by physical, chemical, and mechanical measurements of the material properties according to recognized international standards (e.g., ISO 4049, ISO 29022, ISO 10993). This is typically performed through controlled laboratory testing.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in the context of demonstrating substantial equivalence for dental materials based on physical properties. The "training" for the device's formulation would occur during its research and development phase, but not as part of a formal "training set" for regulatory evaluation in the way AI models are trained.

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

• Not applicable, as there is no "training set" in the context of this device's regulatory evaluation. The development of the dental adhesive formulation (the "training" of the product itself) would rely on material science principles and iterative laboratory testing to achieve desired properties, rather than a "ground truth" derived from patient data or expert consensus.

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GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. GlassLok can be used to bond molar bands to an enamel or metal substrate in a wet or dry field due to its hydrophilic properties. GlassLok is available in natural or blue shade (for easy disclosure at removal).

GlassLok is dispensed in a 2 part (powder and liquid) format with bottle dispensing. A 15cc and 25 cc liquid (in blue or natural shade) along with a 15gm or 100gm powder component will be available as separate components. A convenience kit will also be available in Blue or Natural shade in a starter or economy volume.

GlassLok powder is dispensed to a mixing pad using a measuring scoop and mixed with GlassLok liquid in a ratio of 2:1. The mixed GlassLok composite is then applied to the inside of an orthodontic band and applied to a properly prepared tooth structure. Working Time is 2 minutes and setting time is 5 minutes once the working time has expired. GlassLok can also be cured with a curing light for 20 seconds, if required for polymerization.

Associated accessories include a measuring scoop. Spatula and mixing pad.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Met?": The document states that GlassLok demonstrated "similar or better performance" for shear bond strength and "similar results" for ISO 9917-2:2017 testing when compared to the predicate. For biocompatibility, it states the device "did not directly or through the release of material constituents produce adverse local or systemic effects; it is not carcinogenic or mutagenic, and will not produce adverse reproductive or developmental effects." This indicates the acceptance criteria were met.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the shear bond strength testing or the ISO 9917-2:2017 testing.
• Data Provenance: The document does not specify the country of origin of the data. It also does not state whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, it would most likely be prospective, newly generated data for the purpose of the submission.

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

• The document describes laboratory performance testing (shear bond strength, ISO 9917-2:2017) and biocompatibility evaluations, not a study involving human interpretation where "ground truth" would be established by experts in the clinical sense (e.g., radiologists interpreting images).
• Therefore, this question is not applicable in the context of this device's evaluation as described. The "ground truth" here is objective physical and chemical measurements.

4. Adjudication Method for the Test Set

• As mentioned above, the primary evaluations were laboratory-based performance tests and biocompatibility assessments, not studies requiring expert adjudication of results.
• Therefore, this question is not applicable in the context of this device's evaluation as described.

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

• No, an MRMC comparative effectiveness study was not done.
• This device, GlassLok, is a dental cement, not an AI-powered diagnostic or decision support tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant.

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.
• GlassLok is a physical dental material, not an algorithm or software.

7. The Type of Ground Truth Used

• For performance testing (shear bond strength, ISO 9917-2:2017): The ground truth was based on objective physical and mechanical measurements obtained through standardized laboratory test methods. The predicate device served as the comparative benchmark.
• For biocompatibility: The ground truth was established through biological evaluations and chemical characterization against established international standards (ISO 10993 and ISO 7405:2018), determining whether the material caused adverse biological reactions.

8. The Sample Size for the Training Set

• This is a medical device (dental cement), not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI development is not applicable. The device's performance is inherent to its material properties and manufacturing, not learned from data.

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

• As mentioned above, the concept of a "training set" is not applicable for this type of device. The characteristics and performance of GlassLok are determined through its chemical composition and physical properties, which are then verified through the performance data described.

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