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BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the biting surfaces of teeth. For dental professional use only.

Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear resistant material, ultimately preserving natural tooth structure.

BA Pit & Fissure Sealant is a light activated / photopolymerizable, glass filled, urethane dimethacrylate material that is placed onto an etched enamel surface and light activated for 20 seconds. The result after application is a tooth that has been sealed with a tough, wear resistant material.

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

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

The document does not explicitly state "acceptance criteria" with numerical targets for each test. Instead, it presents the results of various non-clinical performance tests for the subject device (BA Pit & Fissure Sealant) and then compares them to a predicate device (Pulpdent (Activa) Pit & Fissure Sealant with MCP) and sometimes a reference device (Prevent Seal) to establish substantial equivalence. The "acceptance criterion" in this context is generally that the subject device's performance is "similar" or "equivalent" to the predicate device, or that any differences do not raise additional concerns regarding safety or efficacy.

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

The document describes non-clinical benchtop testing. For these types of tests, sample sizes are typically specified within the referenced ISO or ADA standards. However, the exact sample sizes for each specific test conducted for K190998 are not explicitly mentioned in the provided text.

The data provenance is retrospective, as the tests were conducted prior to the 510(k) submission to demonstrate substantial equivalence. The country of origin of the data is not specified, but given the applicant is Apex Dental Materials, Inc. with an address in Lake Zurich, Illinois, it is likely the studies were conducted in the USA or by contract labs.

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

This section is not applicable as the document describes non-clinical benchtop performance testing, not studies involving human interpretation or expert-established ground truth. The "ground truth" for these tests would be the measurement obtained from the laboratory instruments according to the specified standards.

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

This section is not applicable as the document describes non-clinical benchtop performance testing, not studies involving human reading or adjudication.

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

This section is not applicable. The device is "BA Pit & Fissure Sealant," which is a material used for dental sealing, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI component is mentioned.

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

This section is not applicable. The device is a physical material (dental sealant), not an algorithm or software device.

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

The "ground truth" for the non-clinical tests is based on measurements obtained following standardized test methods (e.g., ISO, ADA standards). For example, for compressive strength, the ground truth is the force at which the material fractures, as measured by a testing machine according to the specified standard.

8. The sample size for the training set

This section is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set."

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

This section is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set" or ground truth relevant to AI model training.

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RnD TE and RnD SE is indicated for

• · Desensitizing
• · Rewetting
• · Preventing Bond Degradation

RnD TE and RnD SE is an aqueous primer used to rewet and desensitize a tooth prior to bonding. Bonding to tooth structure presents many challenges including the determination of the proper conditions for starting the bonding protocol. The tooth can be left too wet or too dry which could lead to debonding or post-operative sensitivity. RnD TE and R&D SE have been designed to aid in reaching the appropriate moisture level to provide an initial surface that allows an adhesive to reach its full potential.

The subject device formulations also work to ensure the long term bond integrity by limiting the development of matrix metalloproteinases (MMP's) that have been cited as a contributor to bond degradation over time.

RnD TE and RnD SE will be sold as a kit contain a 3ml bottle of RnD along with a single cavity well and Mircobrush® applicators. RnD has been designed as a single use material and is non-sterile. The material is a single component material that is applied directly to the tooth with no other components added prior to use.

This document describes a 510(k) submission for new dental materials, RnD TE and RnD SE, which are resin tooth bonding agents. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

Although the document is a 510(k) summary and not a detailed study report, we can extract information regarding acceptance criteria and performance data for these dental materials.

Here's an attempt to answer your questions based on the provided text, recognizing that this is a summary and likely doesn't contain all the granular detail of a full study report:

1. Table of acceptance criteria and the reported device performance

   The document does not explicitly state pre-defined "acceptance criteria" as pass/fail thresholds for specific performance metrics. Instead, it compares the performance of the subject devices (RnD TE and RnD SE) against predicate devices to demonstrate "substantial equivalence." The implication is that if the subject devices perform comparably to or better than the predicate devices, they meet the criteria for substantial equivalence.

   Acceptance Criteria (Implied: Comparable to Predicate)	Reported Device Performance (Mean (sd) [n])	Predicate Device Performance (Mean (sd) [n])
   Indications for Use:
   Desensitizing	Yes	Yes
   Rewetting	Yes	Yes
   Preventing/Improve Bond Degradation/Strength	Yes	Yes (Aqua Prep F does not explicitly mention bond degradation)
   Bond Strengths to Dentin (MPa)	RnD TE: 36.2 (5.7) [5]	HEMA GLU: 31.7 (2.0) [5]
   	RnD SE: 33.4 (4.7) [5]	Aqua Prep F: 29.1 (3.1) [5]
   		Hemaseal & Cide: 36.9 (3.1) [5]
   Bond Strengths to Enamel (MPa)	RnD TE: 32.1 (2.9) [5]	HEMA GLU: 32.3 (2.8) [5]
   	RnD SE: 27.8 (3.9) [5]	Aqua Prep F: 27.2 (3.5) [5]
   		Hemaseal & Cide: 37.1 (3.0) [5]
   Film Thickness (microns)	4	HEMA GLU: 5
   		Aqua Prep F: 4
   		Hemaseal & Cide: 5
   pH	Neutral	Neutral
   Components	Aqueous primer with Glutaraldehyde, NaF, HEMA	Various combinations of these components and Chlorhexidine Gluconate

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

   • Sample Size (Test Set): For bond strength tests to dentin and enamel, the sample size was n=5 for each subject device (RnD TE and RnD SE) and each predicate device.
   • Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It is a non-clinical in vitro test, so "retrospective" or "prospective" as typically applied to human studies is not directly applicable.

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

   This non-clinical study involves material property testing (bond strength, film thickness, pH). Ground truth is established by the measurement methodology (ISO 29022:2013 - Dentistry - notched edge shear bond strength test), not by expert consensus on interpretations of images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the way it's used for AI or diagnostic studies does not apply here. The measurements are objective physical properties.

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

   There was no adjudication method as this was a non-clinical, in vitro measurement of physical properties.

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 study was performed. This is a non-clinical laboratory test of dental materials, not a diagnostic device involving human readers or AI.

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

   Not applicable. This is a material science study, not an AI or algorithm-based device.

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

   The ground truth for the performance metrics (bond strength, film thickness, pH) was established through standardized, objective in vitro laboratory measurements based on the ISO 29022:2013 standard.

8. The sample size for the training set

   Not applicable. There is no machine learning or AI component to this device or its evaluation that would require a "training set."

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

   Not applicable, as there is no training set.

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Apex Universal Adhesive is a single component bonding system for:

• Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure . composite material
• Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or . glass ionomer or resin-modified glass ionomer cements
• Bonding CEREC® restorations .
• Desensitization: to treat hypersensitive and / or exposed root surfaces .
• Desensitizing crown preparations .
• Sealing preparations before placing amalgams ●
• Bonding crowns and bridges .
• Bonding in posts and cores .
• Bonding veneers .

Not Found

The provided document is a 510(k) summary for a dental adhesive (Apex Universal Adhesive) and does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

This document is primarily an FDA clearance letter and an "Indications for Use" statement. It confirms that the device has been found substantially equivalent to a legally marketed predicate device, but it does not detail the specific performance studies or acceptance criteria typically associated with medical device validation. Such information would usually be found in the performance data section of the full 510(k) submission, which is not provided here.

Therefore, I cannot provide the requested information.

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ZrP is an ethanol based primer that improve the bond strengths of zirconia oxide restorations to restorative cements and bonding agents.

ZrP is an ethanol based primer

This is an FDA 510(k) clearance letter for a dental product, ZrP, a resin tooth bonding agent. This document does not contain information about acceptance criteria or a study demonstrating the device meets such criteria because it's a clearance letter, not a full submission or study report.

The letter confirms that the FDA has reviewed Apex Dental Materials' 510(k) premarket notification for ZrP and determined it is "substantially equivalent" to legally marketed predicate devices. This means that ZrP is considered as safe and effective as existing devices on the market, but the letter itself does not provide the detailed study results or acceptance criteria that led to this determination. Such information would typically be found within the 510(k) submission itself (which is often extensive and includes bench testing, biocompatibility, and sometimes clinical data).

Therefore, I cannot populate the requested table and details based on the provided text. The document is merely the FDA's decision letter.

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Clean and Boost is an acidic, aqueous cleanser that has been designed to help remove contaminants from the surface of a tooth prior to bonding. These contaminants can be hand piece oil, tooth debris, or imaging powder (used to create digital impressions for CAD/CAM restorations).

Clean and Boost is an acidic, aqueous cleanser that has been designed to help remove contaminants from the surface of a tooth prior to bonding.

The provided text is a 510(k) premarket notification letter from the FDA for a dental product called "Clean and Boost." This document confirms the regulatory approval of the device but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the manufacturer demonstrated substantial equivalence to a predicate device, which is a different type of submission than one requiring detailed performance studies against specific acceptance criteria. The FDA often relies on substantial equivalence for Class II devices like this resin tooth bonding agent.

Therefore, I cannot provide the requested information from the given text because it is not present.

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Metal Opaquer is a light activated (photo initiated via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations.

Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.

Metal Opaquer is a light activated (photo initiated via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations.

Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.

The provided text is a 510(k) premarket notification letter from the FDA to Apex Dental Materials, Inc. for a device named "Metal Opaquer." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or adjudication methods. It is an administrative letter confirming substantial equivalence to a predicate device and outlining regulatory responsibilities.

Therefore, I cannot provide the requested information based on the input text. The document does not describe a study proving the device meets acceptance criteria.

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Seamfree" is intended to be used to lubricate restorative instruments and materials. It can be used in all dental restorations and with any methylmethacrylate based material.

Seamfree™ is a methylmethacrylate based resin material used as a lubricant for dental instruments and composites. The elimination of "tackiness" from dental materials makes the delivery and handling of dental composite materials faster and more consistent. Seamfree™ is activated via free radical polymerization. Seamfree is compatible with all methylmethacrylate based materials.

The provided text is a 510(k) summary for a dental device application and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a study design to prove the device meets them.

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

The document states:

• "Seamfree™ has similar performance to the Bisco Sculpting Resin (510K number K030585, Bisco, Inc.). From the testing observations and analysis, including film thickness, we suggest that Seamfree™ is substantially equivalent to Bisco Sculpting Resin (510K number K030585, Bisco, Inc.)."

This indicates that the device was evaluated against a predicate device based on "testing observations and analysis, including film thickness," to demonstrate substantial equivalence, which is a regulatory pathway, not a performance study against specific acceptance criteria in the way medical AI or diagnostic devices typically undergo.

Without further information from additional documents, it's impossible to provide the requested details.

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Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.

Injectafil™ is a composite material which, when utilized properly, provides a material fordirect dental restorations. Injectafil™ can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. Injectafil™ is compatible with all other methactylate based dental materials.

Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.

The provided document is a 510(k) premarket notification letter from the FDA to Apex Dental Materials, Inc. for their device, Injectafil™. This letter determines substantial equivalence and outlines regulatory requirements. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on the device's substantial equivalence to predicate devices, rather than a detailed report of clinical or performance study results.

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CONFORM™ is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations.

CONFORM™ is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORM™ can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORM™ is compatible with all other methacrylate based dental materials.

CONFORM™ is a light activate (photo initiated, free radical polymerization), flowable hybrid composite material designed to act as a filling material in small restorations or as a liner material for larger restorations. CONFORM™ has been designed to provide a flowable material with a high level of thixotropic behavior. The material also contains fillers to optimize the cured strength and radiopacity properties.

CONFORM™ is a methacrylate (BisGMA) based material that has been designed to work effectively with methacrylate based adhesives and composites currently sold into the dental market.

The provided text is a 510(k) summary for a dental material called CONFORM™ and a letter from the FDA regarding its clearance. It describes the device, its intended uses, and claims substantial equivalence to predicate devices based on "physical testing observations and analysis, including diametric tensile strength and compressive strength." However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets them, as these would typically involve specific metric thresholds, detailed study designs, and human reader performance data, none of which are present here.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or clinical study methods like MRMC or standalone performance.

The submission focuses on chemical composition similarities and basic physical properties to establish substantial equivalence, not on clinical performance metrics typically associated with AI/device acceptance criteria regarding diagnostic accuracy.

Here's what can be extracted based on the provided document, addressing the structure of your request where possible, but highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria with specific quantitative thresholds. The "Performance Characteristics and Concepts" section states: "CONFORM™ has similar handling to the AELITEFLO® (510K number K955292, Bisco, Inc.) composite. From the physical testing observations and analysis, including diametric tensile strength and compressive strength, we suggest that CONFORM™ is substantially equivalent to AELITEFLO® (510K number K955292, Bisco, Inc.)."

This narrative indicates that the acceptance criteria revolved around demonstrating similar physical properties (handling, diametric tensile strength, and compressive strength) to the predicate device, AELITEFLO®. However, specific numeric ranges or targets for these properties are not disclosed in this summary.

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

• Sample size for test set: Not reported in this document. The submission references "physical testing observations and analysis" but does not specify the number of samples or specimens tested.
• Data provenance: Not specified. It can be inferred that the testing was conducted by Apex Dental Materials, Inc. (the manufacturer) as part of their submission process. The country of origin and whether it was retrospective or prospective is not stated.

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

• Not applicable/Not reported. This type of information is typically relevant for diagnostic devices where human experts establish ground truth for clinical cases. For a dental material, the "ground truth" would be established through standardized physical property testing, not expert consensus on diagnostic images.

4. Adjudication method for the test set:

• Not applicable/Not reported. As this pertains to physical properties, not clinical adjudication of cases.

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-powered diagnostic device; it is a dental filling material. Therefore, MRMC studies are not relevant in this context.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• For physical property testing (diametric tensile strength, compressive strength), the "ground truth" is typically established by standardized laboratory measurement protocols using calibrated equipment.

8. The sample size for the training set:

• Not applicable. The concept of "training set" is for machine learning models. For a physical material, there isn't a training set in the same sense. The material formulation itself is developed based on chemical and material science principles, not machine learning.

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

• Not applicable, as there is no "training set" in the context of this traditional medical device. The "ground truth" for the material's properties would be established through the initial R&D and quality control processes based on established material science standards.

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SURPASS™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light-cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resinmodified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.

Indications For Use:

• Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
• Indirect Restorations: to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resin-modified glass ionomer cement.
• Desensitization: to treat hypersensitive and/or exposed root surfaces.
• To bond in a post and core.

SURPASS™ is a light cured (free radical polymerization), self-etching dental adhesive system. designed to provide a dentist with an increased ease of use that is less technique sensitive. The bonding system combines both the etchant and primer applications into one simple step followed by a thin layer of unfilled bonding resin. Thus, allowing for more predictable clinical results without sacrificing bond strength integrity.

SURPASS™ 2 is an ethanol-based adhesive that is dependent on the prepared surface of its conditioner (SURPASS™ 1). This acidic conditioner application is a procedure that is very similar to the phosphoric acid etching process of dentin/enamel substrate in the ECLIPTOMER (510K number K945604, Bisco, Inc.) system. Applying the SURPASS™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol. Once SURPASS™ 2 has been dried a thin layer of SURPASS™ 3 is applied to the SURPASS™ 2 surface and light cured for 20 seconds. The SURPASS™ 3 acts as a superior tie layer between SURPASS™2 and the filling material of choice.

Here's a breakdown of the acceptance criteria and study information for the SURPASS™ Dental Bonding Adhesive Resin, based on the provided document:

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria in the manner one might find for a novel, high-risk device. The primary "acceptance criteria" here relate to the device's physical properties being comparable to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the "physical testing observations and analysis, including shear bond strength to dentin and enamel." It only mentions that this testing was performed to support the substantial equivalence claim.

The data provenance is not specified beyond indicating it was performed by Apex Dental Materials, Inc. It's typical for such tests to be conducted in a laboratory setting, and the nature of the tests (physical properties) suggests a prospective experimental study rather than retrospective clinical data. The country of origin for the data is implicitly the United States, where the manufacturer is located.

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

This information is not provided in the document. For physical property tests of dental bonding agents, "ground truth" is typically established through standardized laboratory measurement protocols and material science principles, rather than expert clinical consensus as might be seen for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes, which is not the primary focus of this submission. The evaluation is based on objective physical property measurements.

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 for evaluating human performance, often in diagnostic imaging, and is not relevant for the physical properties validation of a dental bonding agent.

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

This question is not applicable in the context of this device. A dental bonding adhesive is a material, not a "device" in the sense of a software algorithm or an automated diagnostic tool that would have a standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the SURPASS™ device is based on objective measurements of physical properties, specifically focusing on shear bond strength to dentin and enamel. This is compared against the known properties of the predicate device (ECLIPTOMER).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This device is a material, not an AI/ML algorithm that requires a training set. The submission describes the development of the adhesive system, but not a data-driven model training process.

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

As the concept of a training set is not applicable, this information is also not provided.

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