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ACTIVA PRESTO PACK is intended to be used by dental professionals as a dental filling material for pits, root surface cavities, and Class I, II, III, IV and V restorations include, but are not limited to, direct anterior and posterior restorations (including occlusal surfaces), core build-ups, splinting, and indirect restorations including crowns, inlays, onlays and veneers.

ACTIVA PRESTO™ PACK is an aesthetic, light cure material that contains calcium, phosphate, and fluoride in a durable, wear-resistant resin matrix indicated for all restorative procedures. The material is packable, highly polishable and contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in various shades, has low solubility, low water sorption, high physical properties, and is bioactive as demonstrated within this 510(k) submission.

The document provided is a 510(k) Premarket Notification from Pulpdent Corporation to the FDA for their device, ACTIVA PRESTO PACK. This submission focuses on demonstrating substantial equivalence to a predicate device, ACTIVA Presto (K153249), rather than presenting a study where a device's performance is measured against acceptance criteria in the format typically used for AI/ML devices.

Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to the information contained in this document, as it describes a physical dental material, not an AI/ML diagnostic or assistive device.

However, I can extract the comparative performance data between the proposed device and its predicate, which serves a similar function to "acceptance criteria" in that the new device must perform comparably to the predicate.

Here's the information extracted in a modified format to fit the request where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are implied by the performance of the legally marketed predicate device. The new device "ACTIVA™ PRESTO™ PACK" is compared against "Pulpdent ACTIVA™ PRESTO™ (K153249)". Substantial equivalence is demonstrated by comparable physical properties and intended use.

Study Conclusion: The submission concludes that ACTIVA™ PRESTO™ PACK is substantially equivalent to ACTIVA™ Presto™ (K153249) based on comparable design, composition, performance, and intended use. While some physical properties show variation, the overall performance profile is considered acceptable for substantial equivalence for a dental restorative material. The key difference noted is the change from a "flowable" to a "packable/sculptable" composite.

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

This information is not applicable as the document describes a physical medical device (dental filling material), not software or an AI/ML diagnostic. The performance data presented are physical and chemical properties measured in a lab setting, not clinical data from a test set of patients.

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

This information is not applicable. Ground truth, in the context of AI/ML, refers to definitively established diagnoses or classifications. For a dental material, "ground truth" would be established by standardized laboratory testing methods, not expert consensus on diagnostic images.

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

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of images or data, which is not the case for material property testing.

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

This information is not applicable as the device is a dental material, not an AI/ML assistive device for human readers.

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

This information is not applicable as the device is a dental material, not an algorithm.

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

The "ground truth" for the performance data in this submission is derived from standardized laboratory testing protocols as per international standards like ISO 4049:2019 for Polymer-based restorative materials. These tests define how to rigorously measure properties like flexural strength, depth of cure, water sorption, etc., ensuring reproducible and objective results.

8. The sample size for the training set

This information is not applicable as the device is a physical material, not an AI/ML device that undergoes "training."

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

This information is not applicable as the device is a physical material, not an AI/ML device.

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PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite for the direct bonding of orthodontic brackets. For dental professional use only.

PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite containing modified calcium phosphate that releases fluoride, calcium, and phosphate ions into the oral environment. OBA-MCP is not formulated with Bisphenol A. BisGMA, or BPA derivatives.

The provided text is a 510(k) summary for the PULPDENT OBA-MCP (Orthodontic Bracket Adhesive with MCP). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for an AI/ML medical device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI/ML device is not available in the provided text.

The document primarily addresses:

• Device Description: A light-cure orthodontic adhesive composite containing modified calcium phosphate that releases fluoride, calcium, and phosphate ions.
• Indications for Use: Light cure orthodontic adhesive composite for the direct and indirect bonding of orthodontic brackets. For dental professional use only.
• Predicate Device: PULPDENT OBA - Orthodontic Bracket Adhesive (K911286).
• Reference Device: PULPDENT Solo Flowable Composite with MCP (K153249).
• Biocompatibility Evaluation: Stated that PULPDENT OBA-MCP is substantially equivalent to the predicate (Pulpdent OBA) which has an established history of safe and effective use. It also mentions that the reference device (Pulpdent Solo Flowable Composite with MCP) was tested with a Cytotoxicity Test (ISO 10993-5 2009) and an Implantation Test (ANSI/ADA Specification 41 and ISO 7405) and found to be biocompatible.
• Device Comparison: A table comparing the subject device with the predicate and reference devices on aspects like description, technology/mechanism of action, indications for use, composition, and physical properties (appearance, specific gravity, water absorption, fluoride release, phosphate release, calcium release, compressive strength, flexural strength, diametral tensile strength, light cure set times).
• Discussion of Differences: The key difference is the addition of Modified Calcium Phosphate (MCP) and the removal of BisGMA from the original OBA formulation. The document argues that MCP is biocompatible and that the enamel bond strength of materials with calcium phosphate is comparable to those without it, referencing a study by "Zhang, et.al." (details not provided).

Since this is a submission for an adhesive material, the "performance" discussed is related to its physical and chemical properties and biocompatibility, not diagnostic or predictive accuracy in the context of AI/ML.

To directly answer your request based on the provided text, I must state that the information requested for AI/ML device evaluation is not present.

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Pulpdent's Activa Pit and Fissure Sealant with MCP is intended to seal pit and fissure depressions/faults in the enamel, in the biting surfaces of teeth. For dental professional use only.

Activa Pit and Fissure Sealant is a light cured, flowable dental sealant material, available in a single barrel syringe. This sealant is designed with MCP (Modified Calcium Phosphate); it releases calcium, phosphate, and fluoride ions into the oral environment. It contains no Bisphenol A, no BisGMA, and no BPA derivatives.

This document is a 510(k) premarket notification for a dental pit and fissure sealant. It does not describe an AI/ML-driven medical device, and therefore the requested information regarding acceptance criteria and study data for an AI/ML device is not present in the provided text.

The document discusses substantial equivalence to a predicate device based on material composition, intended use, and physical properties, not on performance metrics of an AI algorithm.

Therefore, I cannot extract the information required by your prompt from the provided text.

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Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner.

Pulpdent Solo Flowable Composite with MCP is a light-cured, radiopaque, glass-filled resin with MCP (modified calcium phosphate filler) that releases calcium and phosphate ions into the oral environment and which may be formulated to release fluoride ions. Solo Flowable Composite with MCP contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in tooth shades, has low solubility, low water sorption and high physical properties.

This document is a 510(k) summary for a dental product, Pulpdent Solo Flowable Composite with MCP. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria for a new AI/software device.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size, etc.) is not available in the provided text as it pertains to a medical device's premarket notification, not an AI/software study.

The document describes the device, its intended use, and compares its physical and chemical properties to two predicate devices to demonstrate that it is substantially equivalent and safe for market introduction. There is no mention of an algorithm, AI, or software development.

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Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation used by dental professionals as filling material in dental restorations.

Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation with both a bioactive resin matrix and bioactive glass fillers. In this context 'bioactive' refers to the release of beneficial ions from the resin and glass fillers into the oral environment. As a resin-modified glass ionomer, Pulpdent RMG/ Fill has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It contains no Bisphenol A, no BisGMA and no BPA derivatives. Pulpdent RMG/ Fill is a paste-paste formulation provided in an automix syringe that is used by dental professionals as filling material in dental restorations.

The provided document describes the "Pulpdent RMGI Fill" device, a resin-modified glass ionomer preparation used as a restorative filling material in dentistry. The submission aims to demonstrate substantial equivalence to predicate devices, primarily through bench testing of physical properties.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for each performance metric. Instead, it presents the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. For this table, I will use the reported performance values for "Pulpdent RMGI Fill" as the "reported device performance." The "acceptance criteria" can be inferred as being at least comparable to or better than the predicate devices to demonstrate substantial equivalence, though specific numerical targets beyond the observed values are not given.

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" for the physical properties. Details regarding the exact sample sizes (e.g., number of specimens tested for flexural strength) for each test are not provided. The data provenance is not explicitly stated beyond "Pulpdent Corporation" as the owner/manufacturer, implying the testing was conducted or sponsored by them. There is no information to indicate if the data is retrospective or prospective; it is bench test data conducted for this submission.

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

This inquiry is not applicable to this submission. The device is a dental restorative material, and the performance evaluation relies on objective physical and chemical bench tests, not on expert interpretation of images or clinical outcomes that typically require "ground truth" establishment by medical experts.

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

This inquiry is not applicable to this submission. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints that require consensus or independent review. The reported data are from objective bench 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

This inquiry is not applicable to this submission. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. The "Pulpdent RMGI Fill" is a material, not an AI-powered diagnostic device.

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

This inquiry is not applicable to this submission. This refers to the performance of an AI algorithm alone, which is irrelevant for a dental material product. The "standalone" performance here refers to the material's properties as measured in a laboratory setting. The presented data is essentially a standalone performance evaluation of the material.

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

The "ground truth" for the reported performance metrics (flexural strength, compressive strength, etc.) are the objective measurements derived from standardized material testing methods (implied by the nature of such tests for dental materials). There is no "expert consensus," "pathology," or "outcomes data" specifically mentioned as ground truth for these physical properties. The values obtained from the bench tests are considered the factual measurements of the material's properties.

8. The sample size for the training set

This inquiry is not applicable to this submission. The "Pulpdent RMGI Fill" is a material, not an algorithm that requires a training set. The term "training set" is used in the context of machine learning and AI development.

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

This inquiry is not applicable to this submission, as there is no "training set" for this material.

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Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation used by dental professionals as a liner, base or luting material in dental restorations.

Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation with both a bioactive resin matrix and bioactive glass fillers. In this context, 'bioactive' refers to the release of beneficial ions from the resin and glass fillers into the oral environment. As a resin-modified glass ionomer, RMG/ Low Viscosity has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It contains no Bisphenol A, no Bis-GMA and no BPA derivatives. RMGI Low Viscosity is a paste-paste formulation provided in an automix syringe.

This looks like a 510(k) summary for a dental cement. The provided information is related to the performance of a medical device (dental material) and its comparison to predicate devices, rather than an AI/ML device that would typically involve acceptance criteria, various types of studies (MRMC, standalone), and ground truth establishment with expert consensus on a test set.

Therefore, many of the requested fields are not applicable in this context. However, I can extract the relevant information regarding the performance testing and comparison for the Pulpdent RMGI Low Viscosity dental cement.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in the format typically seen for a new AI/ML device seeking regulatory approval. Instead, it presents performance testing results for the device and compares them to predicate devices to demonstrate substantial equivalence. The implication is that meeting or exceeding the performance of existing legally marketed predicate devices demonstrates acceptability.

Table 1: Performance Testing Summary for Pulpdent RMGI Low Viscosity

Table 2: Comparison of Performance with Predicate Products

Study Proving Device Meets "Acceptance Criteria":

The study primarily involves bench performance testing as summarized in the tables above, and a comparison to predicate devices. The "acceptance criteria" are implied to be that the device's performance aligns with or is superior to that of the already legally marketed predicate devices. The conclusion states that "Pulpdent RMGI Low Viscosity is substantially equivalent in design, composition, performance and intended use to the predicate products listed above," based on these comparisons and bench testing.

Non-Applicable Fields (for AI/ML device context):

The following fields are not relevant for this 510(k) submission for a non-AI/ML dental material. The document describes physical and chemical properties testing, not diagnostic or predictive performance of an algorithm.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test sets" would be material samples tested for physical properties in a lab setting. The document does not specify sample sizes for these bench tests, but this is standard practice for material testing, not clinical data.
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. Bench testing does not involve expert-established ground truth in this sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI/ML image analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the "ground truth" would be the measured physical properties based on standardized test methods.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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Pulpdent Tuff-Temp 2.0 is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.

Pulpdent Tuff-Temp 2.0 is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.
Dual-cure, glass-filled composite material in two parts. Blended dimethacrylate resins Chemical and Photo-initiators Barium glass and submicron silica fillers.

Below is a summary of the acceptance criteria and the study proving the device meets it, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria (e.g., "must be greater than X MPa"). Instead, it presents the reported performance values as evidence that "Tuff-Temp 2.0 performs as intended" and supports substantial equivalence to predicate devices.

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

The provided text does not specify the sample size used for the bench tests (flexural strength, compressive strength, etc.).

For biocompatibility, the text mentions "Pre-production clinical evaluations of Tuff-Temp 2.0 by dentists in the field and by dentist consultants were positive." However, no specific sample size (number of dentists or patients) is given. It also states, "Tuff-Temp 2.0 has been sold in Europe as a CE marked medical device for the past four months," implying real-world usage data.

The data provenance for the bench tests is not explicitly stated (e.g., country of origin), but it is implied to be from internal testing by Pulpdent Corporation. The clinical evaluation data appears to be from Europe (CE marked medical device) and general "field" evaluations. The study appears to be a prospective evaluation for Tuff-Temp 2.0 (pre-production clinical evaluations and 4 months of sales in Europe), while references to the original Tuff-Temp's performance ("ten years of problem-free use" and "two years on the market") are retrospective observations.

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

The text mentions "Pre-production clinical evaluations of Tuff-Temp 2.0 by dentists in the field and by dentist consultants were positive." It does not specify the exact number of dentists or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method for the clinical evaluations. The statement "Pre-production clinical evaluations... were positive" suggests a general consensus or positive feedback rather than a structured adjudication process.

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

An MRMC study was not conducted. The provided information focuses on bench testing and general clinical feedback, not a comparative effectiveness study involving human readers with and without AI assistance. This device is a material, not an AI or imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a dental material (temporary crown and bridge resin), not an algorithm or AI system. The performance metrics are physical/material properties.

7. Type of Ground Truth Used

For the bench tests (flexural strength, compressive strength, etc.), the "ground truth" is derived from objective laboratory measurements based on established testing standards (though the specific standards are not cited).

For biocompatibility and clinical performance, the ground truth is based on dentist and patient feedback/observations during pre-production clinical evaluations and post-market use in Europe. It also relies on the "problem-free use" history of similar predicate devices and the original Tuff-Temp.

8. Sample Size for the Training Set

This is not applicable as the device is a material and not an AI or machine learning model that requires a training set.

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

This is not applicable as the device is a material and not an AI or machine learning model.

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NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste used as a cavity liner and as a temporary root canal dressing.

NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste that has a pH > 12, is easily removed from the root canal with water, has been designed for ease of handling and will flow through a 27 gauge applicator tip.

The provided text describes a 510(k) premarket notification for a dental device called NuCal. This submission focuses on establishing substantial equivalence to predicate devices based on design, composition, performance, and intended use, rather than presenting a study of a novel AI/ML device. Therefore, much of the requested information about AI model performance is not applicable.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance for NuCal

The acceptance criteria are established through bench testing to demonstrate that NuCal performs as intended and is substantially equivalent to predicate devices.

Regarding the other requested information, it is not applicable or not provided in the document for the following reasons:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not relevant as no AI/ML model was being tested. The "test set" here refers to the samples of NuCal undergoing bench testing. The document does not specify the number of samples used for each bench test, nor their provenance beyond being manufactured by Pulpdent Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product's bench tests is typically established through standardized laboratory procedures and measurements, not expert consensus in the way it's used for AI diagnostic tasks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI models, not for bench testing of a physical substance.

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 document is for a dental material (calcium hydroxide paste), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. NuCal is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance characteristics in the table, the ground truth is based on physical and chemical measurements performed in a laboratory setting (e.g., pH meter for pH, specific gravity meter, visual inspection for appearance/consistency, radiographic assessment for radiopacity, accelerated aging for shelf life).

8. The sample size for the training set: Not applicable. There is no AI model or "training set" in this context.

9. How the ground truth for the training set was established: Not applicable, as there is no AI model or training set.

In summary: The provided document is a 510(k) summary for a conventional medical device (a dental material), not an AI/ML powered device. The "study" described is a series of bench tests to demonstrate the physical and chemical properties of the NuCal product, and its substantial equivalence to previously cleared predicate devices.

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Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.

Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in a soft gel that does not dry out quickly, that flows through small applicator tips and that washes off readily. Etch-Rite Supreme is colored dark purple for contrast with tooth enamel and easy visualization.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Pulpdent Etch-Rite™ Supreme device.

It's important to note that this document is a 510(k) summary for a dental etchant, which is a medical device, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions related to AI device performance evaluation (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of product and are not present in the document. The evaluation of this device is based on bench testing and substantial equivalence to predicate devices.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This is a physical dental etchant, not a software device. The "test set" described in the context of AI/SaMD for ground truth and performance validation is not relevant here. The performance testing refers to bench tests on the product itself. The document does not specify the number of samples used for each bench test, but it is implied that standard laboratory practices for material testing were followed.
• Data Provenance: The bench testing was conducted by Pulpdent Corporation, presumably at their facilities. No country of origin for data (in the sense of patient data) is relevant here, as it's a material science evaluation.

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

• Not applicable. "Ground truth" in the context of clinical expert consensus for imaging or diagnostic algorithms is not relevant for a chemical etchant. The "truth" for the bench tests (e.g., pH value, specific gravity) is determined by objective scientific measurement.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used to establish ground truth from multiple expert opinions, which is not relevant for the bench testing of a chemical product.

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 physical dental material, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant.

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

• Not applicable. This device is a chemical etchant, not an algorithm. Standalone algorithm performance is not a concept applied here.

7. The type of ground truth used:

• For the bench tests, the "ground truth" is defined by objective physical and chemical measurements (e.g., specific gravity, pH, solubility, observation of appearance/odor, and stability testing for shelf-life). These are intrinsic properties of the material and are measured directly.

8. The sample size for the training set:

• Not applicable. This device is a chemical product, not a machine learning model. The concept of a "training set" for an algorithm that learns patterns from data is not relevant.

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

• Not applicable. (As per point 8).

Study Proving the Device Meets Acceptance Criteria

The document describes the "Summary of Performance Testing - Bench" as the study proving the device meets the acceptance criteria.

The study concludes that "Etch Supreme performs as intended" based on the tabulated bench test results. The primary strategy for regulatory approval and demonstrating safety and effectiveness is substantial equivalence to predicate devices, rather than extensive clinical efficacy trials directly for this type of product.

The statement "From the above comparisons, the bench testing, a search of the relevant scientific literature and the organizational experience with the Etch-Rite line of etchants, it can be concluded that Etch-Rite Supreme is substantially equivalent in design, composition, performance and intended use to the predicate products." highlights the approach.

Predicate Devices for Comparison:

• Pulpdent Etch-Rite™ 38% Phosphoric Acid Etching Gel (K882576)
• Pulpdent Etch Royale™ 37% Phosphoric Acid Etching Gel (K031915)

The comparison table (in section {0}) shows the new device's chemical composition (36% Phosphoric Acid, Silica gel, Propylene glycol), consistency (Soft gel), applicator tip (25 gauge, pre-bent), color (Dark purple), and intended use (Etch dentin, enamel and glass ionomer cements) are substantially equivalent to the predicates, with minor variations (e.g., 36% vs. 38% and 37% phosphoric acid, dark purple vs. blue color) that are deemed not to raise new questions of safety or effectiveness. The bench test results then confirm that these minor compositional differences still result in a product that performs functionally as expected for an etchant.

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Embrace Pit and Fissure Sealant, Low Fill is a professional dental material, designed with no Bisphenol A, that contains fluoride releasing, light cured, glass-filled acrylate resins and is less than 10% filled. Embrace Pit and Fissure Sealant, Low Fill is available in two shades (tooth-colored and off-white) and is used to seal the pits and fissures in teeth.

Embrace Pit and Fissure Sealant, Low Fill is a fluoride releasing, light-cured acrylate resin, with no Bisphenol A, that is less than 10% filled and is available in two shades, tooth-colored and off-white.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Embrace™ WetBond™ Pit and Fissure Sealant, Low Fill" device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes performance testing (bench testing) for the device. It does not explicitly state "acceptance criteria" in a pass/fail sense, but rather lists measured performance characteristics which are presumably considered acceptable given the conclusion of substantial equivalence.

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

The document describes bench testing. It does not specify the sample sizes used for each of the performance metrics. The data provenance is from bench laboratory testing conducted by PULPDENT CORPORATION. It is not clinical data, so terms like "retrospective" or "prospective" for human subjects do not apply here.

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

This information is not applicable as the study described is bench testing of physical/chemical properties, not a study involving human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the study described is bench testing of physical/chemical properties.

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 conducted or described in the provided document. The study focuses on bench testing of material properties.

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

No, a standalone study in the context of an algorithm's performance was not conducted or described. This device is a dental material, not an AI or software device.

7. The Type of Ground Truth Used:

The "ground truth" for the bench tests would have been established by standard scientific measurement techniques and established protocols for each material property (e.g., using a universal testing machine for compressive strength, a light meter for cure time, etc.). It's based on objective physical and chemical measurements, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a physical product undergoing bench testing, not a machine learning model.

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

This information is not applicable as there is no training set.

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