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The Parkell Pit and Fissure Sealant is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations.

The Device is a light-cured, flowable, resin-based sealant for prophylactic sealing of pits and fissures as well as for micro-restorative procedures. The Device is light-curable under standard power (600 mW/cm²) and contains filling agents which cause the Device to release and recharge beneficial ions (fluoride and calcium).

The provided text describes the 510(k) clearance for the "Parkell Pit and Fissure Sealant." However, the clearance letter and accompanying 510(k) summary pertain to a physical dental device (a sealant), not an AI/software medical device.

Therefore, many of the requested criteria regarding AI/software performance studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and are not mentioned in this document.

The document focuses on the physical and chemical properties of the sealant and compares them to a predicate device. The performance data is based on non-clinical, in-vitro testing of these physical properties.

Below is the information that can be extracted from the provided text, adapted as best as possible to the requested format, with clear indications where information is not applicable (N/A) due to the nature of the device.

Acceptance Criteria and Device Performance for Parkell Pit and Fissure Sealant

This device is a physical dental sealant, not an AI/software medical device. Therefore, the performance evaluation focuses on physical and chemical properties and biocompatibility, not algorithmic performance on image data.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The testing was non-clinical (in-vitro).
• Data Provenance: Non-clinical physical property testing. Not applicable for geographical or retrospective/prospective distinctions.

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

• N/A. This is a physical dental material. "Ground truth" in this context typically refers to objective measurements from laboratory testing equipment (e.g., universal testing machines for strength, viscometers for viscosity, etc.), not expert interpretation of data like in AI/imaging studies.

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

• N/A. As above, this is laboratory-based physical property testing, not subjective assessment requiring adjudication.

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

• N/A. This is not an AI-assisted device. No MRMC study was performed.

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

• N/A. This is not an algorithm. Standalone performance is not applicable.

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

• Laboratory Standard Measurements / In-vitro physical property testing. The performance criteria (e.g., strength in MPa, shrinkage in %, viscosity in Pa.s) are based on standardized tests for dental materials.

8. The sample size for the training set

• N/A. This is not an AI/machine learning device. No training set was used.

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

• N/A. As above, no training set was used.

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Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.

Parkell Self-Adhesive Cement is a two-component, dual-cured, self-adhesive resin cement. It is designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia. The material also exhibits high bond strength and is radiopaque to allow visibility of excess in sub-gingival areas. Parkell Self-Adhesive Cement will cure in 10 seconds with a dental curing light emitting blue light at 430 - 480 nm and a minimum intensity of 600 mW/cm². The product will self-cure in 3-4 minutes at mouth temperature. Parkell Self-Adhesive Cement will be provided in 5 mL auto-mix syringes. The device comprises catalyst and base components, which are combined just prior to use via a static (1:1) mixing tip which is affixed to the dual chamber syringe.

The provided document is a 510(k) summary for a dental cement (Parkell Self-Adhesive Cement). It aims to demonstrate substantial equivalence to a predicate device. This type of submission relies heavily on bench testing and biocompatibility studies, rather than clinical performance (human trials) for its primary evidence.

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context pertains to the non-clinical performance and physical properties of the dental cement, as well as its biocompatibility, when compared to the established standards and the predicate device.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

The document implicitly defines acceptance criteria by comparing the subject device's performance to the predicate device's performance, or to generally accepted values for dental cements (e.g., "Pass/Fail Criteria"). The performance listed is for the standalone (algorithm only without human-in-the-loop performance) of the material itself.

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of specimens tested for each property). It only indicates that "Performance and Physical Properties" tests were performed.
• Data Provenance: The data is generated from non-clinical (bench) testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA by a company based in New York. The testing would be considered prospective in the sense that it was conducted specifically for this submission.

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

• Number of Experts: This is not applicable to this type of submission. The "ground truth" for the performance and physical properties of the dental cement is established through standardized laboratory test methods (e.g., ISO standards like ISO 4049, ISO 11405, etc.) and direct object measurement, not expert consensus or interpretation.
• Qualifications of Experts: Not applicable, as expert interpretation is not the primary means of establishing "ground truth" for material properties.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies involving human readers/interpreters to resolve discrepancies. For bench testing of material properties, 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:

• Not applicable. This is a submission for a medical device (dental cement), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Quantitative measurements against established international standards and defined criteria. For physical properties, the ground truth is derived from the reproducible results of standardized laboratory tests. For biocompatibility, the ground truth is assessed against the requirements of ISO 10993 series of standards.

8. The Sample Size for the Training Set:

• Not applicable. This is a medical device submission based on bench testing of material properties, not an AI/machine learning model that requires a training set.

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

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

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Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments:

• · treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion;
• · treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning;
• · treatment of tooth hypersensitivity associated with bleaching: and
• · treatment of prepared dentin for fillings and/or prosthetic restorations.

Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment sites. It is a gel which requires no mixing prior to use and which is applied to treatment sites using a standard applicator brush. Parkell® Desensitizer releases calcium and phosphate ions at the treatment site and stimulates hydroxyapatite formation on the surface of treated dentin and in dentinal tubules. In this manner, the Device hardens following application and forms a layer of mineral hydroxyapatite as well as hydroxyapatite plugs which occlude dentinal tubules, which results in the treatment of dental hypersensitivity.
Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.

This document is a 510(k) Summary for the Parkell® Desensitizer Gel, which is a medical device. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study results that explicitly define and prove acceptance criteria in the format requested.

Therefore, the requested information categories related to acceptance criteria, specific studies proving them, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details are not applicable (N/A) in the context of this 510(k) summary for a desensitizer gel.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance (from "6. Comparison of Technological Characteristics" and "Table 5-A")

The acceptance criteria for the Parkell® Desensitizer Gel are predominantly comparative, demonstrating that its performance is equivalent to or better than the predicate device (Teethmate Desensitizer). The key performance criteria evaluated are:

The document states that the "technological differences do not raise issues with respect to substantial equivalence and are addressed by comparative performance data provided within this submission." This indicates that the reported performance for Parkell® Desensitizer Gel met or exceeded the performance of the predicate device for these comparative criteria.

The following questions are not applicable or cannot be determined from the provided 510(k) summary, as it describes a non-AI medical device submission based on substantial equivalence, not a study evaluating AI performance with detailed statistical rigor as implied by the questions:

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

N/A. This document describes in vitro (bench) testing, not a clinical "test set" in the context of an AI/algorithm study. The specific sample sizes for the bench tests (e.g., number of samples for microshear bond strength) are not provided. Data provenance is not described for a biological context.

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

N/A. Ground truth in the context of expert consensus is not relevant for this type of device and testing. The "ground truth" for the performance criteria listed (like chemical composition or bond strength) would be established by validated analytical and mechanical testing methods, not expert consensus.

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

N/A. Adjudication methods like 2+1 or 3+1 are used for human reader studies, typically in diagnostic imaging or similar fields where interpretation is subjective and consensus is needed. This is not applicable to the bench testing described for a dental desensitizer.

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

N/A. No MRMC study was conducted. This device is a treatment product, not an AI diagnostic tool, and involves no human readers or AI assistance.

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

N/A. Not an AI algorithm.

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

The "ground truth" for the bench data (e.g., chemical composition, surface coverage, dentinal tubule occlusion, microshear bond strength) is established through objective, validated laboratory testing methods following relevant ISO standards and material science principles, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set

N/A. Not an AI algorithm.

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

N/A. Not an AI algorithm.

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SmarTemp® X I is a self-curing composite for the fabrication of temporary crowns and bridges, inlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, long-term temporaries, and temporary veneers.

SmarTemp® X1 is a self-curing, resin-based composite, suitable for the fabrication of temporary crowns, bridges, inlays, onlays, and veneers. It is a bis-acryl resin-based material comprising a 10:1 ratio of base to catalyst components, which when expressed by the user from dual-chamber syringes or cartridges mix through standard snap-in accessory mixing tips. SmarTemp® X1 self-cures in approximately 6 minutes at mouth temperature.

SmarTemp® X1 is packaged in any standard, opaque, dual-chamber syringe or cartridge suitable for containing a 10:1 ratio of base and catalyst components, respectively. The syringe or cartridge is accompanied by standard snap-in automix tips.

The provided text describes the regulatory clearance of a dental material, SmarTemp X1, as substantially equivalent to a predicate device, Luxatemp Ultra/Star. It does not contain information about a clinical study or acceptance criteria related to an AI/ML powered medical device.

However, based on the provided document, I can extract information related to the acceptance criteria and testing for the SmarTemp X1 dental material, which serves as a substitute for the requested AI/ML device information.

Here's the breakdown of the acceptance criteria and the study (bench performance testing) for SmarTemp® X1:

SmarTemp® X1 Acceptance Criteria and Bench Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SmarTemp® X1 appear to be based on demonstrating equivalence or meeting certain thresholds compared to the predicate device, Luxatemp® Ultra/Star, for critical physical properties.

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HyperFil®-LV is a dual-cure, tooth shade, resin composite which is indicated for Class I, II, III, IV, and V restorations, including root surface cavities, post cementing, and core build-ups.

HyperFil®-LV is a dual-cure, highly radiopaque, flowable, bulk-fill composite restorative material suitable for direct and indirect restorations. HyperFil®-LV is light-curable to a depth of about 3-4 mm in 40 seconds with a dental curing light emitting at 430 - 480 nm with an intensity of >600 mW/cm². It will also self-cure to any depth in about 4-5 minutes at mouth temperature. HyperFil®-LV contains a combination of filling agents which give restorations constructed with HyperFil®-LV high compressive, tensile, and flexural strength. HyperFil®-LV will be packaged in single dual-chamber 5 mL syringes. The device comprises catalyst and base components, which are combined just prior to use via a mixing tip which is affixed to the dual chamber syringe.

This document, a 510(k) summary for the medical device HyperFil-LV, does not contain information related to an AI/ML device study. Instead, it describes a dental resin composite and its equivalence to a predicate device based on physical and chemical properties. Therefore, I cannot provide details on acceptance criteria, test sets, expert ground truth establishment, or clinical performance related to AI/ML as these are not present in the provided text.

The document discusses the following non-AI related aspects:

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

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1. Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers).
2. Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia).
3. Desensitization of dentin.
4. Sealing of dentin, cementum or enamel.

The Parkell® Universal Adhesive is a single-component, one-bottle, light-cured universal bonding agent which utilizes proven 4-META and 10-MDP chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct and indirect dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.

The Parkell® Universal Adhesive will be provided in a single bottle, with standard applicator brushes for applying the adhesive to treatment surfaces.

The provided document is a 510(k) premarket notification for the "Parkell® Universal Adhesive" and primarily focuses on demonstrating substantial equivalence to a predicate device, the "Scotchbond® Universal Adhesive."

Here's an analysis of the acceptance criteria and study information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the acceptance criterion for Shear Bond Strength is "at least about 6MPa" (denoted as "= 6 MPa | >= 6 MPa | >= 6 MPa |
| Dentin | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Silver alloy | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Cobalt-chrome alloy | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Porcelain, following acid etching | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Porcelain, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Lithium disilicate, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Lithium disilicate, following HF acid etching | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Zirconia, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Composite Resin (self-cure) | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Composite Resin (light-cure) | >= 6 MPa | >= 6 MPa | >= 6 MPa |

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

The document does not explicitly state the sample size used for each shear bond strength test. It mentions that tests were performed "on a variety of dental substrates." The data provenance is not specified (e.g., country of origin, retrospective or prospective), but it's implied to be laboratory testing as part of a premarket notification for a dental adhesive.

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 study described is a laboratory performance test (shear bond strength) for a dental adhesive, not a study involving expert-derived ground truth. The "ground truth" here is the physical measurement of bond strength.

4. Adjudication method for the test set:

This information is not applicable for the same reason as 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:

This is not applicable. The device is a dental adhesive, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical product (dental adhesive), not an algorithm. The shear bond strength tests are a form of standalone performance evaluation for the physical properties of the adhesive.

7. The type of ground truth used:

The "ground truth" for the performance evaluation of the dental adhesive is based on physical measurement of shear bond strength in a laboratory setting, in accordance with ISO standards.

8. The sample size for the training set:

This is not applicable. The device is a physical product (dental adhesive), not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

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BRUSH&BOND® PLUS is indicated for:

1. Direct Dental Restorations (e.g., resin-modified glass ionomer, resin core build-ups, compomers).
2. Indirect Dental Restorations (e.g., metal, resin-based composite, dental ceramics (e.g., porcelain, pressed ceramic, lithium disilicate, zirconia).
3. Desensitization of dentin.
4. Sealing of dentin, cementum or enamel.

BRUSH&BOND® PLUS is a self-etching. self-priming. light-cured bonding system which utilizes proven 4-META chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium, disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.
The BRUSH&BOND® PLUS device is essentially a single-bottle, two-component system, comprising: a liquid resin which comprises monomers and 4-META chemistry, and an activator brush which comprises a bonding promoter to ensure complete activation and polymerization when contacted with the liquid resin. After activation, the activated resin can be applied directly onto restorative surfaces (except dental ceramic surfaces) using the activator brush or any appropriate dental instrument. For ceramic surfaces, the surface must first be coated with a ceramic primer (such as EaZy Primer'M,510K no. 142848) before the activated resin is applied.
BRUSH&BOND® PLUS is packaged as a single 3 mL bottle of liguid resin, an accompanying canister containing 100 activator brushes (either standard size or mini/endo size), and accompanying bottles of Parkell's ceramic rimer Ea Primer'M 5mL "A" and "B" bottles).

The provided text does not contain the acceptance criteria or a study proving that the "Brush & Bond® Plus" device meets such criteria.

This document is a 510(k) premarket notification for a dental bonding agent. It aims to demonstrate substantial equivalence to previously cleared devices, rather than presenting a study where specific acceptance criteria are defined and then met by the device's performance.

Here's a breakdown of why the requested information is largely absent given the input:

• Acceptance Criteria and Reported Device Performance: The document doesn't provide a table of acceptance criteria or specific performance metrics that "Brush & Bond® Plus" is required to meet as a standalone device against a pre-defined standard in real-world or simulated clinical scenarios. Instead, it compares its properties (like bond strength and biocompatibility) to predicate devices to establish substantial equivalence.

  • What is reported: The document states, "The Shear and Tensile Bond Strength tests were performed in accordance with ISO/TS 11405. The shear and tensile strength tests were compared to the Predicates and were determined to be equivalent." This indicates comparative testing, not testing against independent acceptance criteria.

• Sample size used for the test set and data provenance: Not explicitly mentioned for the bond strength tests. The document only states that "The shear and tensile strength tests were compared to the Predicates," without detailing the number of samples or whether the data was prospective or retrospective, or its country of origin.

• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The testing seems to be laboratory-based (shear and tensile bond strength tests), not dependent on expert interpretation of clinical data in the way a diagnostic AI device would be.

• Adjudication method: Not applicable for this type of test.

• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices where human readers interpret images or data. This document is for a dental bonding agent, and the evaluation focuses on physical and chemical properties.

• Standalone performance: The document describes "non-clinical testing" including "Shear and Tensile Bond Strength tests" performed in accordance with ISO/TS 11405. This refers to laboratory testing of the material's properties, which could be considered a form of standalone performance evaluation for the material itself, but not in the context of an "algorithm only without human-in-the-loop performance" typical for AI devices.

• Type of ground truth used: For the bond strength tests, the "ground truth" would be the measured physical properties (e.g., force required to break the bond) obtained through standardized testing methods (ISO/TS 11405), rather than expert consensus, pathology, or outcomes data.

• Sample size for the training set: Not applicable, as this is not an AI/machine learning device.

• How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence of a dental bonding agent to existing predicate devices based on technological characteristics and non-clinical performance (like bond strength and biocompatibility), rather than presenting a study of a diagnostic AI device against pre-defined acceptance criteria.

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EAZY PRIMER™ is indicated for use in enhancing bonding between dental ceramics (such as porcelain, lithium disilicate, zirconia or hybrid ceramics) and methacrylate resin-based materials. In addition, EAZY PRIMER™ is indicated for use in enhancing bonding between fractured dental ceramics and methacrylate resin-based materials during intra-oral repair of damaged restorations.

EAZY PRIMER™ is a two-part, self-cured dental primer which is used for enhancing the bond between dental ceramics (such as porcelain, lithium disilicate, zirconia, or hybrid ceramics) and methacrylate resin-based materials. The device is intended to be used to prepare surface treatments of restorations and repairs. The device comprises both a silane-coupling agent and a phosphate-coupling agent which generate significant bond strengths between dental ceramic surfaces and methacrylate resin-based materials. The device is packaged in two 5-milliliter bottles ("bottle A" and "bottle B"), which will be mixed in a 1:1 ratio just prior to use.

The document discusses the EAZY PRIMER™, a two-part, self-cured dental primer. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices rather than describing a study with acceptance criteria and device performance in the context of diagnostic accuracy, which is common for AI-driven medical devices.

However, based on the information provided, I can extract and infer details related to the device's performance through Shear Bond Strength tests, which serve as a measure of its effectiveness in enhancing bonding.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

The acceptance criteria for the EAZY PRIMER™ are the Shear Bond Strengths, which are set at ">10MPa" for bonding to various dental ceramics. The reported performance of the device meets these criteria.

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

The document explicitly states that "Shear Bond Strength tests were performed in accordance with ISO/TS 11405." However, it does not specify the sample size used for these tests nor does it mention the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document. For a physical materials test like Shear Bond Strength, the "ground truth" is typically established by the standardized testing methodology itself, rather than expert consensus on interpretive data.

4. Adjudication method for the test set:

This information is not applicable as the tests are objective physical measurements rather than subjective interpretations requiring adjudication.

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

This is not applicable. The device is a dental primer used for enhancing bonding, not an AI-driven diagnostic or interpretative tool that would involve human readers.

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

This is not applicable as the device is a chemical dental product, not an algorithm. The "standalone" performance here refers to the physical properties of the primer itself, which were tested according to ISO/TS 11405.

7. The type of ground truth used:

The ground truth used for evaluating the EAZY PRIMER™ is based on standardized physical property measurements, specifically "Shear Bond Strength" tests performed in accordance with ISO/TS 11405. This is an objective measurement of a material's adhesive strength, not an expert consensus, pathology, or outcomes data in the typical sense of medical device evaluations.

8. The sample size for the training set:

The concept of a "training set" is not applicable to this type of medical device (a chemical primer) evaluation. Training sets are relevant for machine learning algorithms.

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

This is not applicable for the same reason as point 8.

In summary:

The provided document describes the regulatory approval of a dental primer based on its physical properties (Shear Bond Strength) meeting established criteria. The evaluation framework is specific to material science rather than diagnostic imaging or AI-driven tools, hence many of the requested categories (like "experts," "adjudication," "MRMC," "training set") are not relevant or not detailed in this context.

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A dual-cure, composite resin core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated.

A dual-cure, composite resin, core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated. It is substantially equivalent to many predicate materials that include self-, light-, and dual-cure types. This material incorporates fluoride-containing (trace amounts) glass filler particles. No Bisphenol-A or its precursors are used in the manufacturing process. The material is supplied in light-safe dual-barrel cartridges.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Parkell, Inc. Absolute Dentin II device:

Based on the provided 510(k) summary (K132115) for Absolute Dentin II, this document pertains to a dental material, specifically a composite resin core build-up material, and not an AI/ML-driven medical device. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The "acceptance criteria" for this type of device are primarily based on demonstrating substantial equivalence to predicate devices through biocompatibility testing and non-clinical performance testing of mechanical properties.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (as demonstrated by testing) and Reported Device Performance:

Since this is a material rather than a diagnostic or therapeutic AI device, "acceptance criteria" are typically defined by meeting established ISO standards for biocompatibility and demonstrating comparable physical properties to predicate devices. The document lists the tests conducted and states that all tests were passed.

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

• Sample size: Not specified. Standard biocompatibility tests and material property tests typically use a predefined number of samples as per the relevant ISO or ASTM standards, but the exact count is not given in this summary.
• Data provenance: Not explicitly stated but assumed to be from laboratory testing as per the ISO standards mentioned.

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 testing conformity rather than a diagnostic device requiring expert interpretation of results for ground truth. Biocompatibility and mechanical property tests have objective readouts.

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

• Not Applicable. Adjudication methods are relevant for subjective interpretations, which are not involved in these types of material tests.

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-driven device.

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

• Not Applicable. This is not an AI-driven device.

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

• For biocompatibility: Ground truth is established by the specific, objective criteria defined within each ISO standard (e.g., cell viability percentages, absence of specific reactions).
• For non-clinical performance (mechanical properties): Ground truth is established by physical measurement against established material science parameters and comparison to predicate device performance.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

• Not Applicable. As above, no training set for an AI/ML model.

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RETRACT is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

RETRACT is a dental product capable of controlling gingival bleeding, temporarily displacing the marginal gingiva and temporarily drying the gingival sulcus around a tooth. The paste allows the dental clinician to perform operative procedures without interference from moisture or excess soft tissue. RETRACT is supplied in 0.5 ml syringes with a hand plunger, intra-oral tips, Instructions for Use & MSDS.

This Preamarket Notification (510(k)) is for the RETRACT Gingival Retraction/Hemostatic Paste.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct performance study to meet those criteria. Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that the device is deemed acceptable if it has similar indications, principles of operation, and technological characteristics to legally marketed devices, and the minor differences do not raise new questions of safety or effectiveness.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence):

2. Sample Size and Data Provenance

The document does not describe a specific clinical or performance study with a defined sample size for a test set. The evaluation is based on comparing the device's characteristics and ingredients to existing predicate devices already on the market. Therefore, there is no mention of a "test set" in the traditional sense, or data provenance.

3. Number of Experts and Qualifications for Ground Truth

Since no independent study with a test set was conducted to establish ground truth, there is no information provided on the number or qualifications of experts used for this purpose.

4. Adjudication Method

As there was no specific test set requiring ground truth establishment, there is no adjudication method mentioned.

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

An MRMC study was not conducted, as the device approval pathway was based on substantial equivalence and not a comparative effectiveness study involving human readers or AI assistance. The device is a paste, not an imaging or diagnostic AI system.

6. Standalone Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not conducted. This device is a dental material, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is implicitly the established safety and effectiveness profile of the predicate devices. The new device is deemed acceptable because its characteristics align with or are similar to those already proven safe and effective in the market. It's an expert judgment based on prior approvals and material science, rather than a new "ground truth" derived from patient outcomes or pathology for this specific device.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an algorithm or machine learning. The "training" for this type of device development would involve research and development to formulate the paste and ensure its chemical and physical properties are suitable, often based on existing knowledge of similar materials.

9. How Ground Truth for the Training Set Was Established

Since there is no explicit "training set" as understood in algorithm development, there's no information on how its "ground truth" was established. The development of the device would rely on established scientific principles for material formulation, chemical compatibility, and efficacy of known hemostatic and gingival retraction agents, guided by regulatory requirements and industry standards.

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