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Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement:

1. Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays
2. Endodontic posts
3. Cement-retained implant restorations/abutments (i.e. screws and crowns)
4. Veneers

Choice 2 DC is a color stable dual-cured, resin luting/veneering cement that is specially formulated for the cementation of indirect restorations made from Glass Ceramic, Lithium Disilicate, Porcelain, Composite, Metal, or Zirconia.

The provided FDA 510(k) clearance letter for Choice 2 DC, a dental cement, does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or similar diagnostic device. The document explicitly states:

"Clinical testing is Not Applicable."

Instead, the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate and reference devices. The acceptance criteria for this device are based on performance metrics defined by ISO standards for dental cements, rather than diagnostic accuracy metrics.

Therefore, many of the requested elements for describing an acceptance criteria study related to AI/ML or diagnostic performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific 510(k) clearance.

However, I can still extract details about the non-clinical testing and the "acceptance criteria" as implied by the standards chosen for comparison:

Non-Clinical Performance Study Details for Choice 2 DC Dental Cement

The provided FDA 510(k) summary for Choice 2 DC Dental Cement describes non-clinical testing performed to demonstrate substantial equivalence to predicate and reference devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this dental cement, "acceptance criteria" are implied by adherence to established ISO standards and performance at least equal to predicate devices. The document does not provide specific numerical "reported device performance" values for each test, but states that the device met the requirements of the ISO standard and performed at least equal to predicate and reference devices.

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

• Sample Size: Not explicitly stated in the 510(k) summary. These details would typically be found in the full test reports referenced by the ISO standards.
• Data Provenance: The testing was non-clinical (laboratory testing of material properties). Therefore, concepts like country of origin or retrospective/prospective collection are not applicable.

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

• Not applicable. This was non-clinical material testing based on ISO standards, not a diagnostic study requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical material testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not applicable. This applies to diagnostic devices, not dental cements.

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

• Not applicable. This applies to diagnostic algorithms, not dental cements.

7. The Type of Ground Truth Used

• The "ground truth" (or reference standard) was defined by the methodologies and reference materials/procedures specified in the international standards ISO 4049:2019 (Dentistry — Polymer-based restorative materials) and ISO 29022:2013 (Dentistry — Adhesion — Notched-edge shear bond strength test). This involves standardized laboratory measurements of material properties.

8. The Sample Size for the Training Set

• Not applicable, as this is not an AI/ML device or a clinical study requiring training data.

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

• Not applicable, as there is no training set mentioned or implied.

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• Direct anterior and posterior restorations
• Core build ups
• Splinting
• Indirect restorations including inlays, onlays, and veneers

Quantium is a light-cured, radiopaque, universal composite. Quantium is designed to blend with the tooth structure when used alone or in the layering technique.

The provided FDA 510(k) summary for the Quantium device (K242816) does not contain information typically associated with AI/ML device evaluations, such as specific acceptance criteria related to accuracy, sensitivity, specificity, or studies involving human readers or ground truth established by experts.

Instead, this document focuses on the nonclinical testing of a dental composite resin material against a predicate device and relevant ISO standards. Therefore, many of the standard questions regarding AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

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

The document states that nonclinical testing of Quantium and the predicate device was selected from the "FDA Guidance Document, Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff, issued October 2005." The tests were conducted according to ISO 4049:2019.

Acceptance Criteria (Implied by adherence to ISO 4049:2019 and comparison to predicate):
The acceptance criteria are implicitly that Quantium must meet or exceed the requirements set forth in ISO 4049:2019 for the tested properties and perform equal to or better than the predicate device (TrusFIL Universal Composite Restorative, K202063).

Reported Device Performance:
"The nonclinical tests performed on Quantium and the predicate device showed Quantium performed equal to or better than the predicate. In addition, both devices meet the requirements set forth in ISO 4049:2019."

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 describes nonclinical testing of material properties, not a clinical study involving patients or human data. Therefore, the concept of a "test set" and "data provenance" in the context of patient data is not applicable here. The sample sizes for each specific material test (e.g., number of specimens for flexural strength) are not detailed in this summary document. These details would typically be found in the full test reports, which are 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)

Not applicable. This is a nonclinical material science study, not an AI/ML clinical study requiring expert ground truth for interpretation.

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

Not applicable, as this is a nonclinical material science study.

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 is a nonclinical material science study.

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

No. This is a nonclinical material science study, not an AI/ML device.

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

The "ground truth" for this device is established by physical and chemical measurements conforming to ISO 4049:2019 standards and direct comparison to a legally marketed predicate device. This is a material science "ground truth," not a clinical ground truth.

8. The sample size for the training set

Not applicable. This is a nonclinical material science device, not an AI/ML device that requires a training set.

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

Not applicable.

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• 1. Metal crowns, bridges, inlays (includes porcelain-fused -to- metal and composite-to-metal)
• 2. Porcelain, Ceramic Crowns, inlays, and onlays (includes alumina and zirconia)
• 3. Resin crowns, bridges, inlays, and onlays (resin-based composite-ceramic hybrid)
• 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
• 5. Implant supported restorations
• 6. Orthodontic Appliances (brackets, bands)
• 7. Lining and basing applications under restorations

TheraBase and TheraBase Ca are a self-etching, self-adhesive, dual-cured resin luting cement and base/liner that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and non-metal/fiber posts, as well as cast posts) and basing/lining under restorations. TheraBase is a paste/paste, fluoride- and calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. TheraBase Ca is a paste/paste, calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. They are easy-to use, require only a short chair time, and produce a good bond to most dental materials. The cements are available in a Natural shade. They are radiopaque, allowing for easy identification on radiographs.

The document you provided is a 510(k) summary for a dental device, TheraBase / TheraBase Ca. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or a comparative effectiveness study with human readers.

Instead, it presents performance data for the physical and mechanical properties of the dental cement, comparing them to established ISO standards or internal benchmarks.

Therefore, I cannot fulfill all parts of your request as it pertains to an AI/ML device with ground truth, expert adjudication, or MRMC studies. However, I can extract the relevant information regarding the device's physical and mechanical properties and present it in your requested format.

Here's the breakdown based on the provided document:

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

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1. Treats hypersensitive teeth
2. Treats exposed dentin and root sensitivity

FluoroCal is a fluoride & calcium releasing varnish with Tri-Calcium Phosphates (TCP) for application to enamel and dentin for the treatment of hypersensitive teeth. FluoroCal delivers targeted and sustained release of fluoride & calcium over 24 hours. This varnish penetrates and seals dentin tubules, providing immediate relief of sensitivity. Available in Spearmint; sweetened with Xylitol.

The provided document is a 510(k) summary for a dental product called "FluoroCal," a 5% Sodium Fluoride Varnish with Tri-Calcium Phosphate. This document primarily focuses on establishing substantial equivalence to predicate devices and does not describe a study to prove acceptance criteria in the typical sense of a clinical trial for a novel medical device.

FluoroCal is a dental varnish, not an AI/ML device, and therefore the acceptance criteria and study description provided in the document are for the physical/chemical properties and biocompatibility of the varnish, not for an algorithm's performance.

Based on the provided information, I can extract the following relevant details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "Performance Data" and "Technological Characteristics" that serve as the indirect acceptance criteria by demonstrating equivalence to predicate devices.

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

The document does not specify a "test set" in the context of an algorithm's performance evaluation. The performance data is based on laboratory testing of the FluoroCal varnish itself. Therefore, sample sizes for these material property tests, and their provenance, are not detailed in this summary.

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

Not applicable, as this is not an AI/ML device and no "ground truth" for a test set was established by experts in this context. The determination of "meets requirements" or "equivalent" is based on established ISO/ANS/ADA standards and laboratory measurements.

4. Adjudication method for the test set:

Not applicable. There was no "test set" requiring adjudication in the context of expert review for an algorithm.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" in this context refers to established material property standards and scientific measurements:

• ISO 17730:2014(E) for Fluoride Content
• ANS/ADA Spec #8 4.3.2 for Consistency
• Laboratory measurements for pH, Calcium Release, Fluoride Release, and SEM for Tubule Occlusion.
• ISO 7405:2008 and ISO 10993-1 for Biocompatibility.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device and no "training set" was used.

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

Not applicable, as this is not an AI/ML device and no "training set" was used.

In summary: The provided document is a regulatory submission demonstrating the substantial equivalence of a dental varnish (FluoroCal) to existing predicate devices based on its chemical composition, physical/mechanical properties, and biocompatibility, as measured against established scientific standards. It does not describe an AI/ML-driven medical device or a study involving human readers or algorithm performance metrics.

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TheraCal DC is indicated for use for:

1. Pulpotomy
2. Temporary Filling Material
3. Repair of Root Perforations
4. Repair of Furcation Perforations
5. Repair of Perforating Internal and External Resorptions
6. Root-End Filling in Endodontic Surgery
7. Pulp Exposures (Direct Pulp Capping)
8. Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates

TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.

This document is a 510(k) summary for TheraCal DC, a dental restorative material. The purpose of a 510(k) is to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. This document does not describe a study involving an AI-powered diagnostic device, but rather a dental material. Therefore, many of the requested categories for AI device studies are not applicable.

Here's an attempt to extract relevant information and note the inapplicable categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the "Modified TheraCal DC" (the subject device) to the "TheraCal DC (K143292)" (the predicate device). The acceptance criteria are essentially that the modified device performs equivalently to the predicate in key physical and mechanical properties.

• Resin Composition: Hydrophilic resin to facilitate calcium release (same as predicate)
• Method of polymerization: Dual-Cure (same as predicate)
• Method of Application: bonding agent not required (same as predicate)
• Ions Released: Calcium and hydroxide (same as predicate) |
  | Radiographic Appearance | Radiopaque (same as predicate - ISO 4049:2009 7.14) | Radiopaque |
  | Ions Released (Property) | Calcium releasing (same as predicate) | Calcium releasing |
  | pH | Basic (same as predicate) | Basic |
  | Shelf-Life | Improved shelf-life over predicate (predicate was 12 months) | 18 months (predicate was 12 months, this is an improvement) |
  | Physical/Mechanical Properties | Equivalent performance to predicate in: Flexural strength, Compressive strength, Dimetral tensile strength, Working time, Bond strength, Radiopacity, Water sorption and solubility, Calcium release, pH. | Direct comparison testing demonstrates that TheraCal DC is equivalent to the predicate device. (Specific values not provided in this summary, but implied to meet equivalence.) |
  | Biocompatibility | Meets requirements of ISO 7405:2008 and ISO 10993-1:2009 | An evaluation was conducted using these standards, and it is concluded that TheraCal DC meets the requirements of the testing. |

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

• Sample size: Not specified. The document states "direct comparison testing" and "evaluated" for physical/mechanical properties and biocompatibility, but the exact sample sizes for each test are not listed in this summary.
• Data provenance: Not specified, but standard ISO/ANSI/ADA test methods are referenced, implying laboratory testing. The company, Bisco, Inc., is based in Schaumburg, Illinois, USA. The testing would presumably have been conducted in a lab environment. The study is prospective in the sense that the testing was performed specifically to support this 510(k) application for the modified device.

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

Not applicable. This is a material science study, not a clinical study requiring expert interpretation of results. The "ground truth" is established by adherence to recognized international and national standards for material testing (e.g., ISO 4049, ANSI/ADA Spec. No. 27, ISO 7405, ISO 10993).

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI diagnostic device.

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

Not applicable. This is not an AI diagnostic device.

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

The "ground truth" for the material's properties is defined by objective physical and mechanical measurements according to established international and national standards (e.g., ISO 4049:2009 for flexural strength and radiopacity, ANSI/ADA Spec. No. 27:1993 for compressive strength, ISO 7405:2008 and ISO 10993-1:2009 for biocompatibility).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable.

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1. Direct anterior and posterior restorations (including occlusal surfaces)
2. Base/liner under direct restorations
3. Core build-ups
4. Splinting
5. Indirect restorations including inlays, onlays and veneers
6. Restorations of deciduous teeth
7. Extended fissure sealing in molars and premolars
8. Repair of defects in porcelain restorations, enamel, and temporaries

REVEAL Bulk is a light-activated restorative composite, optimized to allow for simpler and faster posterior restorations. REVEAL Bulk is intended to combine superior levels of handling, depth of cure, and polishability to perform as an optimum functional and aesthetic bulk fill composite.

The provided document is a 510(k) summary for a dental restorative material called REVEAL Bulk. It does not describe a study involving an AI device or a comparative effectiveness study with human readers. Instead, it focuses on demonstrating substantial equivalence of REVEAL Bulk to an existing predicate device based on physical, mechanical, and biocompatibility properties.

Therefore, many of the requested categories for AI device studies, such as sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and performance of the REVEAL Bulk device for its intended use as a dental restorative material.

Acceptance Criteria and Reported Device Performance for REVEAL Bulk

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample sizes (number of specimens) used for each physical/mechanical test.
• The data provenance is from laboratory testing conducted by Bisco, Inc. (the applicant) on their REVEAL Bulk device. The standards referenced (e.g., ISO 4049:2009, ISO 7405:2008, ISO 10993-1) are international standards for dental materials and biocompatibility.

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

• This question is not applicable as the "ground truth" for this medical device submission relies on established international standards (e.g., ISO for physical properties) and scientific principles for material characterization, rather than human expert consensus on diagnostic images or clinical outcomes. The performance is measured against these objective standards and comparison to a legally marketed predicate device.

4. Adjudication method for the test set:

• This question is not applicable as there is no human interpretation or adjudication involved in the objective physical and mechanical property testing of a dental restorative material. The results are quantitative measurements against defined criteria.

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

• This question is not applicable. The submission is for a dental restorative material, not an AI device. No MRMC study was conducted.

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

• This question is not applicable. The submission is for a dental restorative material, not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on established international standards and predicate device performance. For example:
  • ISO 4049:2009 for polymer-based restorative materials, specifying test methods and requirements for properties like flexural strength, radiopacity, water sorption, solubility, and depth of cure.
  • ISO 7405:2008 and ISO 10993-1 for biological evaluation of medical devices (biocompatibility).
  • Equivalence to a legally marketed predicate device (Filtek Bulk Fill K141081) for other properties like diametral tensile strength, volumetric shrinkage, compressive strength, wear, polish retention, surface hardness, and cusp deflection.

8. The sample size for the training set:

• This question is not applicable. This is not an AI device or a machine learning model, so there is no "training set."

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

• This question is not applicable. There is no training set for this type of device submission.

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Pit and fissure sealant

HAPI Seal is a light-cured, fluoride containing, resin-based pit & fissure sealant designed for sealing the enamel pits and fissures of teeth.

The provided text is a 510(k) summary for a dental device, HAPI Seal, and does not describe a study involving an AI algorithm or human readers. Therefore, several of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable.

Here's the information that can be extracted from the document:

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

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

• Oral Toxicity Study: 10 mice were used for a 14-day study.
• Other performance tests: The document mentions that HAPI Seal "meets" or is "equivalent" to the predicate for various physical/mechanical properties based on specific ISO or ANSI/ADA standards. However, it does not explicitly state the sample sizes used for these tests. The data provenance is not specified (e.g., country of origin, retrospective or prospective), but these are laboratory tests done to regulatory standards.

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 studies described are laboratory performance and biocompatibility tests, not studies requiring expert interpretation of data.

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

This information is 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:

This information is not applicable.

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

This information is not applicable.

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

The ground truth for the physical/mechanical properties and biocompatibility was established through adherence to recognized international and national standards (e.g., ISO 6874:2015, ISO 4049:2009, ISO 29022:2013, ANSI/ADA Spec No. 27, ISO 7405:2008, ISO 10993-1).

8. The sample size for the training set:

This information is not applicable as this is not an AI algorithm study.

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

This information is not applicable.

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CeraClean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.

CeraClean is used outside the mouth, as an extraoral cleaning gel suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. CeraClean is applied through a single-use tip or application to the prosthetic restorations and rinsed off prior to the application of a primer or cement for final placement of the restoration.

The provided text describes a 510(k) summary for the CeraClean device, which is an extraoral cleaner for dental restoration surfaces. The study presented aims to demonstrate substantial equivalence to a predicate device, Resolve 2.0.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a typical clinical study sense with quantitative thresholds for sensitivity, specificity, and so on. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data. The implicit acceptance criterion is that CeraClean's performance must be "substantially equivalent" to that of the predicate device, Resolve 2.0, across various relevant parameters.

Note on Differences: The document acknowledges differences in chemical composition (e.g., CeraClean is water-based gel with xanthum gum and potassium hydroxide vs. acrylate resin-based with silicate and chlorohexidine for Resolve 2.0; CeraClean is non-abrasive while Resolve 2.0 is abrasive). However, it argues these differences do not raise new questions of safety or effectiveness as both are water soluble, used outside the mouth, and rinsed off.

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

The document does not explicitly state the sample size for the test set. For the shear bond strength test based on modified ISO 29022:2013, it implies that the device was tested, but the number of samples or cases is not provided. Similarly, for water solubility, pH, and SEM EDX, specific sample sizes are not mentioned.

The data provenance is not specified. It's likely an in-house or contracted laboratory study, but the country of origin or whether it's retrospective or prospective data is not detailed. Given the nature of a 510(k) submission for a cleaning solution, this would typically involve laboratory testing rather than human subject data.

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

This information is not provided in the document. For a product like CeraClean, "ground truth" might refer to analytical chemistry results or physical property measurements rather than expert interpretations of images or clinical outcomes. The document relies on established ISO standards (ISO 29022:2013 for bond strength, ISO 7405:2008 and ISO 10993-1:2009 for biocompatibility) for its performance claims, implying that adherence to these standards constitutes the "ground truth" of performance evaluation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. Given that the tests are laboratory-based (shear bond strength, pH, water solubility, SEM EDX, biocompatibility), results would typically be quantitative and objectively measured, not requiring expert adjudication in the same way clinical imaging studies do.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is involved. CeraClean is an extraoral cleaning solution, and its performance is evaluated through material science and biocompatibility tests.

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

The performance tests conducted (Shear Bond Strength, Water Solubility, pH, SEM EDX, Biocompatibility) are standalone laboratory tests of the device's physical and chemical properties. There is no "human-in-the-loop" component to these performance measurements as they assess the intrinsic properties and effectiveness of the cleaning solution itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation appears to be based on:

• Established material science standards and measurements: e.g., modified ISO 29022:2013 for shear bond strength, direct measurements for pH and water solubility, SEM EDX for residue removal.
• Biocompatibility standards: ISO 7405:2008 and ISO 10993-1:2009.

This is not expert consensus, pathology, or outcomes data in the clinical sense, but rather objective, repeatable measurements under controlled laboratory conditions referencing international standards.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device or study design. Training sets are used in machine learning or AI algorithm development. CeraClean is a physical cleaning solution, not a software algorithm.

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

As there is no training set, this question is not applicable.

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ALL-BOND UNIVERSAL w/BAC adhesive is used for:

1. all direct restorations
2. all indirect restorations
3. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
4. desensitizing/sealing of tooth structure
5. protective varnish for glass ionomer fillings
6. priming of enamel for orthodontic use

BISCO's ALL-BOND UNIVERSAL w/BAC is a light-cured single-component dental bonding agent that combines etching, priming, and bonding with benzalkonium chloride (BAC) in one bottle. ALL-BOND UNIVERSAL w/BAC is an ethanol/water-based dental adhesive which bonds to dentin and cut and un-cut enamel. ALL-BOND UNIVERSAL w/BAC has been designed to be fully compatible with light-cured and dual-cured composite materials. ALL-BOND UNIVERSAL w/BAC can be used for the bonding of both direct and indirect restorations. ALL-BOND UNIVERSAL w/BAC may be used with or without phosphoric acid etchant.

The provided text describes the acceptance criteria and performance of the "All-Bond Universal w/BAC" dental adhesive.

Here's the information requested, extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • For Biocompatibility, an "Oral Toxicity Study" used 10 rats.
  • For other physical/mechanical properties (Bond Strength, Moisture Tolerance, Film Thickness, Water Sorption / Solubility, Immediate Bond Strength, Bond Strength Durability, Solvent Evaporation, pH), specific sample sizes are not explicitly stated in the provided text. The testing is described as occurring for "All-Bond Universal w/BAC".
• Data Provenance: The text does not explicitly state the country of origin or whether the studies were retrospective or prospective. It is implied these are laboratory-based studies conducted by or for the manufacturer (Bisco, Inc. in Schaumburg, IL, USA) for regulatory 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)

• The studies described are physical/mechanical property tests and biocompatibility tests, not studies requiring expert interpretation (like medical imaging). Therefore, there were no human experts establishing "ground truth" in the diagnostic sense. The "ground truth" is established by the standardized testing methodologies (e.g., ISO, ADA/ANSI standards) and measurements of physical properties.

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

• This concept is not applicable here as the studies are laboratory-based physical and mechanical property tests and animal biocompatibility studies, not studies requiring human adjudication of subjective data. Therefore, none was used.

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 MRMC comparative effectiveness study was done. This device is a dental adhesive, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

• This device is a dental adhesive, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance demonstrated is the standalone performance of the material itself.

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

• The "ground truth" for the performance of the dental adhesive is based on standardized laboratory testing methods (e.g., modified ISO 29022:2013 for bond strength, ISO 4049:2009 for film thickness, ADA/ANSI Specification No. 27 for water sorption/solubility, and ISO 7405:2008 and ISO 10993-1 for biocompatibility). For biocompatibility, it was specifically an "Oral Toxicity Study" with animal models.

8. The sample size for the training set

• There is no training set mentioned or implied, as this is a physical product (dental adhesive), not a machine learning model.

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

• As there is no training set, this question is not applicable.

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Use TheraCem to cement the following:

• 1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
• 2. Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
• 3. Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
• 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
• 5. Implant supported restorations
• 6. Orthodontic Appliances (brackets, bands)

TheraCem is a self-etching, self-adhesive, dual-cured resin luting cement that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and nonmetal/fiber posts, as well as cast posts). TheraCem is a paste/paste, fluoride- and calciumreleasing, luting cement which requires no etching, no priming or bonding of the prepared surfaces. It is easy-to use, requires only a short chair time, and produces a good bond to most dental materials. The cement is available in a Natural shade. It is radiopaque, allowing for easy identification on radiographs.

The provided text is a 510(k) summary for the dental cement TheraCem. It describes the device, its indications for use, technological characteristics, and performance data, but it does not contain the information you're looking for regarding acceptance criteria and study details for an AI/CADe device.

Specifically, the document focuses on demonstrating substantial equivalence to predicate dental cements based on physical and mechanical properties, not on AI-assisted diagnostic or decision-making capabilities. Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: The document provides a table of physical/mechanical properties tested for TheraCem and states its equivalence to predicates or compliance with ISO standards, but these are not "acceptance criteria" in the context of an AI device's diagnostic performance (e.g., sensitivity, specificity, AUC).
2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
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: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: 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: For a dental cement, "ground truth" would relate to its physical properties (e.g., bond strength, setting time), which are measured according to established standards (e.g., ISO).
8. The sample size for the training set: Not applicable, as there's no AI model being trained.
9. How the ground truth for the training set was established: Not applicable.

The document is for a medical device (dental cement) that does not involve AI or diagnostic imaging. The performance data presented is about the product's physical and chemical characteristics, which are compared to predicate devices for substantial equivalence.

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