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The product is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers.

TempFIT Temporary Crown and Bridge Resin is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers. The mixing ratio, based on volume, base paste: catalyst paste =1:1 or 10:1. TempFIT Temporary Crown and Bridge Resin is delivered in a bio-cartridge. The curing mechanism between methacrylates is self-curing, which fundamentally belongs to free radical polymerization in reaction principle. Free radical polymerization typically occurs in unsaturated molecules containing double bonds. Both methacrylate resins in TempFIT Temporary Crown and Bridge Resin and silane coupling agents on filler surfaces contain numerous carbon-carbon unsaturated double bonds. When the two-component system is mixed, a redox reaction generates abundant free radicals that initiate the polymerization of these double bonds.

This FDA 510(k) clearance letter is for TempFIT Temporary Crown and Bridge Resin. It addresses the substantial equivalence of this device to a legally marketed predicate device (Luxatemp Ultra/Star, K101710).

However, this document does not describe the kind of AI/ML device study that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, and the use of expert readers for ground truth establishment. Instead, it focuses on the equivalence of a dental biomaterial product based on its physical, chemical, and biological properties.

Therefore, I cannot directly extract the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document describes a non-clinical testing approach for a dental material.

Here's how I can address your request based on the provided text, while highlighting the limitations:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Dental Material):

Study Details (Non-Clinical for a Dental Material):

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

   • The document mentions "test results demonstrated the qualification and substantial equivalence." However, it does not specify the sample sizes of the materials tested for each physical property.
   • Data Provenance: The tests were performed according to ISO 10477 and Internal standard SOP of the company (HUGE SOP). Given the submitter's location (Rizhao City, China), the testing was likely conducted in China. The study is a non-clinical, laboratory-based performance test, not involving patient data.

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

   • Not applicable in this context. The "ground truth" for chemical and physical properties are established through standardized laboratory measurement techniques as per ISO standards and the company's internal SOPs, not through expert human interpretation in the way AI/ML ground truth is established.

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

   • Not applicable. This is a non-clinical material test, not a subjective human-reading assessment.

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

   • No. This type of study is relevant for AI-assisted diagnostic devices. This submission concerns a dental biomaterial.

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

   • Not applicable. This is not an algorithm-based device.

6. The type of ground truth used:

   • The "ground truth" for the physical and chemical properties of the temporary crown and bridge resin are the established measurement protocols and thresholds defined by ISO 10477 and the company's internal SOPs. These are objective, quantitative measurements (e.g., MPa for flexural strength, µm/mm³ for water sorption).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "development" of the material would involve chemical formulation and iterative testing, but not a "training set" in the computational sense.

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

   • Not applicable, as there is no training set for this type of device.

In summary, the provided FDA clearance letter demonstrates a material's safety and effectiveness through adherence to established material standards and comparison to a predicate device, rather than through an AI/ML performance study.

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TopCEM-Try in Veneer Try-in Gel is used to evaluate the shade and the matching of the restoration prior to permanent cementation.

TopCEM-Try in Veneer Try-in Gel is primarily made of polyethylene glycol, inorganic fillers and pigments. It is used to indicate the color of the Light Cure Veneer Cement before use, so as to select the right color to achieve the best aesthetic effect. The polyethylene glycol and inorganic filler in the Veneer Try-in Gel component are hydrophilic and can be rinsed off with a water gun nozzle after the color test operation. The principal organic components of TopCEM-Try in Veneer Try-in Gel are mixtures of polyethylene glycol, and the inorganic fillers loading is about 50% by volume.

The provided document is a 510(k) premarket notification for a dental product, TopCEM-Try in Veneer Try-in Gel. It concerns the substantial equivalence determination for this device, which means proving it is as safe and effective as a legally marketed predicate device.

The document does not describe an AI medical device or a study involving AI, machine learning, or human readers. Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance are not applicable to this document.

However, I can extract the information that is provided regarding the device's performance based on the general format and content of the filing:

1. A table of acceptance criteria and the 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)

The document refers to "Bench testing" performed on the subject device and the primary predicate device. It also states that biological evaluation (biocompatibility tests) was performed.

• Sample size: Not specified.
• Data provenance: Not specified, but the tests were performed by Rizhao HuGe Biomaterials Company, Ltd. in China. The nature of these tests (bench testing, biocompatibility) implies they are prospective tests conducted on manufactured samples.

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. The "ground truth" for the physical and chemical properties as well as biocompatibility tests would be the established scientific and regulatory standards (e.g., ISO 10993 for biocompatibility, and the company's internal standards for physical properties). These do not typically involve human expert consensus in the same way an AI diagnostic device's ground truth would.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing a consensus ground truth in studies involving human interpretation or subjective assessments, which is not the case for the type of bench testing and biocompatibility reported here.

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 medical device.

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

Not applicable. This is not an AI medical device.

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

• For physical and chemical properties: "HuGe internal inspection standard" for parameters like appearance, shade, liquidity, and consistence.
• For biocompatibility: International Standard ISO 10993-1 and FDA guidance for biological evaluation of medical devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

Not applicable. There is no training set mentioned as this is not an AI/ML device.

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Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.

HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast. HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.

Here's a breakdown of the requested information, based on the provided FDA 510(k) summary for the HF-Etchant Hydrofluoric Acid Etching Gel.

Important Note: The provided document is a 510(k) summary for a medical device (HF-Etchant Hydrofluoric Acid Etching Gel), not an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML studies (like expert adjudication, MRMC studies, training/test set sample sizes, and ground truth establishment for AI) are not applicable to this type of submission and will be marked as such. The device described is a chemical etching gel, not a software algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified for formal "test sets" as would be done for an AI/ML algorithm. The performance was determined through internal testing of the device itself.
• Data Provenance: Not explicitly stated, but the testing was "according to Internal standard SOP of the company." This implies in-house testing by Rizhao HuGe Biomaterials Company, Ltd. (China).
• Retrospective or Prospective: Not applicable in the context of an AI/ML algorithm. The performance testing appears to be prospective (i.e., conducted on the manufactured device).

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

• Not Applicable. This is a chemical device, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for its properties (like pH, viscosity) is determined by standard chemical and physical measurement techniques.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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 not an AI/ML device. An MRMC study is not relevant.

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

• Not Applicable. This is not an algorithm.

7. The Type of Ground Truth Used

• For physical and chemical properties (Thermostability, Hydrofluoric acid content, Rotational viscosity value, pH value): The ground truth is established by quantitative measurements against the company's internal standard operating procedures (SOPs).
• For shelf life: The ground truth is established through real-time stability testing over a 2-year period.

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. See point 8.

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TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.

TopCEM Ceramic Primer Ceramic Coupling Agent is common oral cementation repair auxiliary materials. In the process of using the product, TopCEM Ceramic Primer Ceramic Coupling Agent is placed between the prosthesis and resin adhesives, which can form the bonding layer of tooth tissue - light cure dental adhesive layer - resin cement layer - ceramic coupling agent - prosthesis, so as to achieve better bonding effect. TopCEM Ceramic Primer Ceramic Coupling Agent does not have direct contact with tooth tissue during use. TopCEM Ceramic Primer Ceramic Coupling Agent is mainly composed of silane coupling agent, acid acrylate and volatile organic solvent.

The provided document is a 510(k) Premarket Notification from the FDA for a dental bonding agent. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain any information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy, as would be expected for an AI/ML medical device. The device described is a "Ceramic Primer Ceramic Coupling Agent," which is a chemical product used in dentistry, not an AI/ML-driven diagnostic or prognostic device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test sets or data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing of physical properties and biocompatibility for a chemical product. It states:

• "Summary of Non-clinical testing": "The physical properties of the subject device, including Appearance, Solid Content, Bond Strength (MPa), Whether there are traces left on the glass panel surface, Packing Amount Tolerance and Detection of Infrared Characteristic Peaks, were determined and tested according to Internal standard SOP of the company, and the test results demonstrated the qualification and substantial equivalence when compared to the predicate device."
• "Summary of Clinical testing": "Clinical test is not applicable."

This indicates that the "acceptance criteria" and "proof" in this context relate to chemical and physical properties, and biocompatibility, as evaluated through internal SOPs and comparison to a predicate device, rather than the performance metrics typically associated with AI/ML diagnostic tools.

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TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.

TopCEM-Veneer Light Cure Veneer Cement is a visible light curing cementation system that is designed for use with porcelain/ceramic and composite veneer restorations. The simple and versatile shade selections allow this material to be used with a wide range of veneer cases. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBP ADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. Light Cure Veneer Cement is radiopaque, allowing for easy identification on radiographs. It is classified as Type 2 Class 2 Group 1 in accordance with ISO 4049:2019, which belongs to materials whose use requires the energy to be applied intro-orally.

The provided text is an FDA 510(k) summary for a dental cement (TopCEM-Veneer Light Cure Veneer Cement). It describes the device, its intended use, and bench testing performed to demonstrate substantial equivalence to predicate devices.

However, the request asks for information about acceptance criteria and a study proving a device meets these criteria, specifically in the context of an AI/ML-enabled medical device performance study. The document supplied does not describe an AI/ML-enabled device or any studies involving human readers, AI assistance, or ground truth establishment by experts. Instead, it describes a conventional material science device (dental cement) and its testing against physical and chemical properties standards (ISO 4049, ISO 29022).

Therefore, I cannot extract the requested information (such as AI/ML specific acceptance criteria, sample size for test/training sets in an AI context, expert qualifications, MRMC studies, standalone algorithm performance, or ground truth establishment for AI models) from the provided text. The document refers only to "bench testings" of physical and chemical properties.

Response based on the provided document:

The provided document describes the acceptance criteria and study for a dental cement, not an AI/ML-enabled medical device. Therefore, many of the requested categories related to AI/ML device performance studies (e.g., number of experts, adjudication methods, MRMC studies, standalone AI performance, training/test set details for AI) are not applicable and are not present in the text.

Here's an attempt to answer the relevant parts based only on the provided text, while explicitly stating when information is not applicable or not provided for an AI/ML context.

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 for Test Set: Not explicitly stated in terms of specific number of samples tested for each criterion. The document states "Bench testings were performed on the subject device and the predicate devices."
• Data Provenance: Not specified in terms of country of origin for the testing data. The submitter is Rizhao HuGe Biomaterials Company, Ltd., China. The tests refer to international standards (ISO).
• Retrospective or Prospective: Not applicable for this type of material bench testing.

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

• This is not applicable as the study is not based on expert interpretation of medical images or data requiring "ground truth" establishment by human experts in the context of an AI/ML device. The "ground truth" here is determined by compliance with material properties standards (e.g., a film thickness measurement must be ≤ 50 µm).

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

• Not applicable. This concept typically applies to human reader studies or expert consensus for AI/ML ground truth, which is not described here.

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 was not done. The device is a dental cement, not an AI/ML diagnostic or assistive device.

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

• Not applicable. This device is a physical material, not an algorithm.

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

• The "ground truth" or reference for the physical and chemical properties tests is established by international standards (ISO 4049, ISO 29022) and FDA guidance for dental composite resin devices. The "ground truth" is adherence to predefined physical/chemical limits.

8. The sample size for the training set

• Not applicable. This device is a physical material, not an AI/ML model that requires a training set.

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

• Not applicable. As stated above, this is a physical material tested against standards, not an AI/ML model with a training set.

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· Permanent cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
· Permanent cementation for all types of root canal posts.
· Core build-ups.

TopCEM Dual Cure Resin Cement is a versatile and ultimate dental dual cure (chemical and/or light cure) luting cement containing paste-paste of Base and Catalyst. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. It is also a core build up material in syringes. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBPADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 3 microns. TopCEM Dual Cure Resin Cement is delivered in either two separated single syringes for Hand-mix or double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A1 (Light), A2 (Medium), A3 (Dark), White Opaque) and Opaque (Universal Opaque). TopCEM Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs. It belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The curing mechanism of the predicate devices and subject device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.

The provided text describes the 510(k) premarket notification for a dental product called "TopCEM Dual Cure Resin Cement" and its substantial equivalence to predicate devices. This document refers to the safety and efficacy of a material (dental cement), not a device in the context of an AI/ML-based diagnostic or imaging device.

Therefore, the requested information regarding acceptance criteria and studies that prove a device meets criteria (such as sample sizes, expert-established ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable to this document.

The document focuses on the physical, chemical, and biocompatibility properties of the dental cement, demonstrating its similarity to existing, legally marketed predicate devices through bench testing and adherence to international standards (ISO 4049, ISO 29022) and FDA guidance for dental composite resin devices.

Key points from the document relevant to its acceptance:

• Acceptance Criteria for the Dental Cement: The acceptance criteria for this dental cement are based on adherence to specific physical and chemical property standards outlined in ISO 4049 and ISO 29022, as well as FDA guidance for dental composite resin devices.
  • ISO 4049: This standard specifies requirements for resin-based dental restorative materials.
  • ISO 29022: This standard specifies test methods for the evaluation of bond strength of dental adhesive systems.
  • FDA Guidance: "Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005."
• Demonstration of Performance: The device's performance was demonstrated through bench testing against these established standards and internal company standards.
• Substantial Equivalence: The primary method of acceptance is demonstrating "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective as a legally marketed device. This is primarily established by comparing:
  • Indications for Use
  • Technological Characteristics (monomer matrix, fillers, physical form, curing method, delivery form, radiographic appearance)
  • Physical/Chemical Properties (conformance to ISO standards)
  • Biocompatibility (conformance to ISO 10993 standards)

Table of Acceptance Criteria and Reported Device Performance (as presented in the document for TopCEM Dual Cure Resin Cement):

Regarding the specific questions about device performance as if it were an AI/ML device:

1. AI/ML Acceptance Criteria/Performance Table: Not applicable. The device is a dental cement, evaluated by material properties, not AI/ML metrics like sensitivity, specificity, or AUC.
2. Sample sizes for test set and data provenance: Not applicable. No test set of medical images or patient data was used. Performance was based on bench tests of material samples.
3. Number of experts and qualifications for ground truth: Not applicable. Ground truth was established by physical, chemical, and biocompatibility testing according to ISO standards, not expert clinical interpretation.
4. Adjudication method: Not applicable. Material properties are objectively measured, not subject to adjudication.
5. MRMC comparative effectiveness study: Not applicable. No human readers or AI assistance in a diagnostic context.
6. Standalone (algorithm only) performance: Not applicable. The device is a material, not an algorithm.
7. Type of ground truth used: Bench test results from standardized physical, chemical, and biocompatibility tests.
8. Sample size for training set: Not applicable. There is no software or AI model to train.
9. How ground truth for training set was established: Not applicable.

In conclusion, the provided document clearly details the regulatory submission and acceptance of a dental material based on its chemical, physical, and biocompatibility properties, demonstrating substantial equivalence to predicate devices through standardized bench testing. It does not relate to the performance of an AI/ML-based medical device.

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Proseal Enamel Coating Resin is a light curing material for sealing the enamel pits and fissures of teeth.

Proseal Enamel Coating Resin is a light-curing fissure sealant and is mainly composed of methacrylate resin, photo initiator system and inorganic fillers. It is packaged in syringes or bottles.

This document is a 510(k) Summary for the Proseal Enamel Coating Resin. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance in a diagnostic or clinical setting.

Therefore, many of the requested fields cannot be filled from the provided text as they relate to the performance of an AI/diagnostic device, which is not what this document describes.

Here's an analysis based on the available information:

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

The document states that in-vitro bench tests were performed and that the "test results indicated that the Proseal Enamel Coating Resin meets the pass/fail criteria and supports substantial equivalence when compared to the predicate device on physical properties." It also notes that the device is classified as Class 2 sealant in accordance with ISO 6874:2015.

The specific acceptance criteria (pass/fail criteria) are implied to be derived from ISO 6874:2015 and FDA guidance "Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005". However, the document does not list the specific numerical acceptance criteria.

The reported device performance is only described qualitatively as "meets the pass/fail criteria." Specific numeric performance values for each test (depth of cure, flexural strength, shear bonding strength, compressive strength, water sorption, solubility, film thickness, and elastic modulus) are not provided in this summary.

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 mentions "in-vitro bench tests" for physical properties and "Biocompatibility tests" but does not specify the sample size for these tests. Data provenance (country of origin, retrospective/prospective) is not mentioned for the testing.

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

Not applicable. This is a material science study, not a study evaluating human expert performance or diagnostic accuracy.

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

Not applicable. This is a 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

Not applicable. This is a material science product, not an AI or diagnostic device that would involve human readers.

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

Not applicable. This is a material science product.

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

For the physical property tests, the "ground truth" would be the scientifically established and standardized measurement protocols and evaluation criteria defined by ISO 6874:2015 and FDA guidance for dental composite resin devices. For biocompatibility tests, the ground truth would be established by ISO 10993 standards.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained.

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

Not applicable. There is no AI algorithm being trained.

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TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material indicated for:

• Class III and V restorations
• Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
• Base/liner under direct restorations
• Repair of small defects in indirect restorations
• Pit and fissure sealant
• Undercut blockout
• Repair of resin and acrylic temporary materials

TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material intended to restore carious lesions or structural defects in teeth in combination of a bonding agent and with or without other materials such as luting, etching agents, cavity liners, universal composites and others commonly used in a tooth restoration. The principal organic components are mixtures of dental methacrylate resins (Bis-GMA, TEGDMA, EBPADMA). The inorganic filler loading is about 46% by volume having particle size range of about 0.01 to 3 microns. It is packaged in syringes and single-dose capsules. Single-dose delivery is intended for single patient (single use) only to prevent cross-contamination between patients.
Available shades include opaque dentin shades and regular body shades. All shades are radiopaque.

The provided document is a 510(k) premarket notification for a dental restorative material, TrusFIL-Flow Flowable Composite Restorative. It aims to demonstrate substantial equivalence to a predicate device, not to prove the device meets acceptance criteria for an AI/algorithmic medical device, as implied by the user's request.

Therefore, the document does not contain the information needed to answer the user's questions about acceptance criteria and study details for an AI/algorithmic device. The document primarily focuses on physical and chemical properties, biocompatibility, and intended use for a conventional dental material.

Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance for an AI/algorithmic device. The "acceptance criteria" presented are pass/fail criteria for physical properties of a dental material according to ISO standards and FDA guidance, not for an AI.
• Sample size used for a test set or data provenance for an AI.
• Number of experts or their qualifications for establishing ground truth for an AI test set.
• Adjudication method for an AI test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Standalone performance for an algorithm only.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI.
• Sample size for a training set for an AI.
• How ground truth for a training set was established for an AI.

The document explicitly states under "10. Clinical Performance Data": "Not applicable. Clinical performance testing has not been performed on the subject device." This further confirms that no clinical studies or AI performance evaluations, as requested, were conducted or reported here.

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Used for etching of tooth enamel and/or dentin prior to the applications of bonding direct filling, repairing or enamel surface coating materials, as well as cementations such as crowns, bridges, inlays/onlays, veneers, posts, splints, orthodontic brackets, etc. made of resin composites, porcelains/ceramics, metals and their combinations. Can also be used for cleaning of restoration surfaces prior to repairing or cementation.

Phosphoric Acid Etching Gel is a flowable gel with excellent water solubility and miscibility. Using a disposable dispensing tip, Phosphoric Acid Etching Gel can be directly applied onto the tooth surface. Its color is blue, which can be identified easily on tooth or a repairing surface with contrast. Phosphoric Acid Etching Gel is used as an auxiliary material in the dental bonding procedure followed by the use of Light Cure Dental Adhesive.

The provided text is a 510(k) summary for the Phosphoric Acid Etching Gel. This document describes the device and its equivalence to a predicate device based on physical and chemical properties and technological characteristics, not on a study proving a diagnostic device meets acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods cannot be extracted from this document.

This document focuses on regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study for a diagnostic AI/ML device.

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TrusFIL Universal Composite Restorative is a visible light curing dental restorative material indicated for:

• Direct anterior and posterior restorations (including occlusal surfaces);
• Core Build-ups;
• Splinting:
• Indirect restorations including inlays, onlays and veneers.

TrusFIL Universal Composite Restorative is a visible-light activated, restorative composite designed for use in anterior and posterior restorations. The principal organic components are mixtures of dental methacrylate resins (Bis-GMA, EBPADMA). The inorganic filler loading is about 54% by volume having particle size range of about 0.01 to 2 microns. It is packaged in syringes and single-dose capsules. Single-dose delivery is intended for single patient (single use) only to prevent cross-contamination between patients.

Available shades include opaque dentin shades, regular body shades and enamel shades. All shades are radiopaque.

The provided document is a 510(k) summary for a dental composite restorative device (TrusFIL Universal Composite Restorative). It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain information about an AI/ML medical device. Therefore, it is not possible to describe acceptance criteria and a study proving an AI/ML device meets them, as requested in your prompt. The questions in your prompt (e.g., sample size for test set, number of experts, MRMC study, ground truth) are relevant to the evaluation of AI/ML devices, but this document pertains to a traditional dental material.

The data presented is primarily in-vitro bench testing of physical and chemical properties of the dental composite, not clinical performance for an AI/ML algorithm.

Therefore, I cannot fulfill your request as the provided text does not contain the necessary information about an AI/ML device and its performance study.

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