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3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping.

3M VitCal liner/base is a two-part paste/paste, light-cured system. The paste/paste materials are contained in a Micro-Mix Syringe Dispensing System. This dispensing system provides simultaneous dispensing and mixing of each component for a consistent mix and direct application into the mouth. The composition is a combination of a resin-modified glass ionomer and calcium-based material. The first paste contains a radiopaque fluoro-aluminosilicate glass and calcium filler. The second paste contains a modified polyalkenoic acid. VitCal liner/base provides the major benefits of glass ionomer cements including adhesion to the tooth structure and sustained fluoride release. Additionally, VitCal linerbase offers a high pH environment and a combination of a prolonged working time with an on-demand set time achieved by light curing.

The provided text is a 510(k) Premarket Notification for a dental product, 3M™ VitCal Liner/Base. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

It is important to note that this document is for a DENTAL LINER/BASE material, NOT an AI-powered medical device for diagnosis or image analysis. Therefore, the requested information regarding AI study design, such as MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets in an AI context, and effect sizes of human readers with AI assistance, is not applicable to this submission.

The acceptance criteria and "study" proving the device meets them, in this context, refer to bench testing of physical, chemical, and biological properties (biocompatibility) to demonstrate that the new dental material performs comparably or acceptably to existing predicate devices.

Here's the relevant information extracted from the document, tailored to the type of device:

1. Table of Acceptance Criteria and the Reported Device Performance (Bench Test Results):

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

• Sample Size for Bench Tests: The specific number of samples (e.g., n=5, n=10) for each individual bench test (e.g., compressive strength, flexural strength) is not explicitly detailed in this summary. However, standard deviations are provided for most quantitative measurements (e.g., 103 ± 10), implying multiple replicates were used for testing. For "Dentin Tubule Occlusion," it states "Only 1 lot of 3M VitCal was tested."
• Data Provenance: The data is generated from laboratory bench testing of the dental material. The document does not specify a country of origin for the testing, but the submitting company (3M ESPE Dental Products) is based in St. Paul, MN, USA. The testing is prospective in the sense that it's performed specifically to characterize the device for this submission.

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

• This question is not applicable as the "test set" here refers to physical and chemical properties measured in a lab, not clinical images or patient data analyzed by experts.
• For biocompatibility assessment, it states: "A Diplomate of the American Board of Toxicology has assessed the safety of this product and has determined that it is safe for its intended use." This is an expert opinion on the safety, but not "ground truth" derived from patient data.

4. Adjudication Method for the Test Set:

• This question is not applicable as there is no expert reading or interpretation of "cases" involved. Performance is based on direct physical and chemical measurements.

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

• No, an MRMC study was NOT done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation, which is not the function of this dental liner/base material.

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

• No, this is not an algorithm. This is a physical dental material. The "standalone performance" is represented by the bench test results of the material itself.

7. The Type of Ground Truth Used:

• The "ground truth" for this device is based on established industry standards and physical/chemical measurements (e.g., ISO 9917-2 standards for dental cements, ASTM/ISO standards for mechanical properties, and analytical chemistry methods for ion release). For biocompatibility, it's based on toxicological assessments against established biological safety standards (e.g., ISO 10993).

8. The Sample Size for the Training Set:

• Not applicable. This device is a material, not an AI model requiring a training set.

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

• Not applicable. This device is a material, not an AI model, and therefore has no "training set."

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Apacal ART and is suitable for several indications including:

• · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials.
• · Indirect pulp capping or management of deep caries lesions, or
• · Direct pulp capping

CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled.

Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including;

• · Indirect pulp capping or management of deep caries lesions, or
  · Direct pulp capping

CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.

Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips.

CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips.

Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips.

CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.

The provided text describes the substantial equivalence of Prevest Denpro Cavity Liners to predicate devices, focusing on physical parameters and material composition rather than AI performance. Therefore, many of the requested categories related to AI studies and expert review are not applicable to this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests results met the criteria in standards." The acceptance criteria are implicit in the ISO and USP standards referenced for each test. The performance is reported as meeting these standards.

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

The document does not specify the sample sizes used for the testing of these physical and chemical properties. The data provenance is presumed to be from the manufacturer's testing conducted in India (Prevest Denpro Limited, Jammu, India). The testing is described as being performed "according to protocols based on" relevant ISO and USP standards, indicating manufacturer-conducted in vitro/bench testing.

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 medical device clearance based on material properties and performance against established international standards, not an AI or diagnostic device requiring expert ground truth for image interpretation or similar tasks.

4. Adjudication method for the test set

Not applicable. This type of adjudication is typically used in clinical or image-based studies. The "adjudication" here is the assessment against specified ISO/USP standard requirements.

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. The device is a dental material, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on the objective measurements against established international and national standards (ISO and USP) for material properties (e.g., flexural strength, depth of cure, water sorption/solubility, pH, setting time, radio-opacity).

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.

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

Not applicable, as there is no training set.

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Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp. Permanent root canal filling in combination with gutta-percha points following a retreatment procedure.

BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is hydrophilic mineral root canal sealer presented as a ready-to-use paste in a syringe. BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is based on a tricalcium silicate reaction with in situ water to seal the root canal. The sealer ensures a good adaptation to the root canal, tight interface with gutta-percha point and an adequate radiopacity. It is an implantable medical device intended to be used in dentistry. It is part of endodontic cements used as permanent root canal sealer. BioRoot™ Flow 0.5g. BioRoot™ Flow 2g is used in combination with gutta-percha points to fill the root canal.

This document, K212283, is a 510(k) summary for a medical device called "BioRoot™ Flow 0.5g, BioRoot™ Flow 2g" manufactured by Septodont. It describes a root canal filling resin. The document establishes substantial equivalence to predicate devices based on non-clinical and clinical testing, primarily focusing on physical-chemical properties and functional characteristics.

Here's an analysis based on the provided text, addressing your questions:

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

The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that were tested for the new device. Instead, it presents a side-by-side comparison of the subject device (BioRoot™ Flow) with its predicate devices (BioRoot™ RCS and iRoot SP) and claims "substantial equivalence" based on various characteristics. The performance reported is essentially the successful demonstration of this equivalence through bench testing and by leveraging clinical data from the predicate.

Here's a table based on the provided "Side-by-Side Comparison" section, highlighting where performance is discussed implicitly:

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

The document primarily relies on non-clinical bench testing for the new device and equivalence to a predicate that likely had clinical data.

• Test Set Sample Size: The document does not specify the sample sizes for the bench tests conducted on BioRoot™ Flow. It states "extensive bench testing" and that results demonstrated "substantial equivalence" for physical-chemical properties, setting time, sealing, and adhesion.
• Data Provenance: The document does not specify the country of origin of the data nor whether the studies were retrospective or prospective. Given it's a 510(k), regulatory submissions typically rely on a mix of existing data and new testing. The reference to "existing data" for biocompatibility suggests some retrospective component, but the bench testing would be prospective for the new device.

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

The document does not mention using experts to establish ground truth for a test set. This device is a dental material, and its equivalence is based on physical, chemical, and biological properties, not interpretative tasks (like image reading) that would require expert consensus for ground truth.

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

Not Applicable. Since there is no mention of expert review or interpretation of data in a way that would require adjudication (e.g., in an image-based diagnostic study), no adjudication method is specified.

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 done. This is a root canal filling material, not an AI-assisted diagnostic device. The "clinical testing" mentioned (Section 8) refers to demonstrating clinical equivalence to the primary predicate based on the predicate's existing clinical data, rather than performing new clinical trials for the subject device. It states, "Clinical evaluation data obtained using the equivalent device, BioRoot™ RCS, was used to support clinical evidence of BioRoot™ Flow 0.5g, BioRoot™ Flow 2g and can be extended to BioRoot™ Flow 0.5g, BioRoot™ Flow 2g in terms of clinical performance and clinical safety."

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

Not Applicable. This is a physical medical device (root canal sealer), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm does not apply.

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

For the non-clinical bench testing of the subject device (BioRoot™ Flow), the "ground truth" would be established by standardized laboratory testing procedures and predefined specifications for material properties (e.g., setting time measurement according to ISO standards, or specific measurements for sealing and adhesion). For biocompatibility, it's based on chemical characterization and toxicological risk assessment, and biological data (likely in vitro and/or in vivo animal studies as per ISO 10993).

For the claim of clinical equivalence, the "ground truth" for the predicate device's clinical performance would have been established through its own clinical studies and outcomes data, which are then leveraged for the new device by demonstrating substantial equivalence in technology and intended use.

8. The sample size for the training set

Not Applicable. This document describes a traditional medical device (dental material), not an AI/ML product that would have a "training set."

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

Not Applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process for that purpose.

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CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including:

• Temporary disinfectant dressings in the obturation of root canals;
• Indirect pulp capping or management of deep caries lesions; or
• Direct pulp capping.

CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.

This document describes the premarket notification (510(k)) for CleaniCal, a Calcium Hydroxide Cavity Liner. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and comparison of characteristics, rather than a clinical study evaluating diagnostic accuracy or reader performance of an AI-powered device.

Therefore, many of the typical elements used to describe the acceptance criteria and the study proving an AI-powered device meets those criteria are not directly applicable or available in this type of submission. This premarket notification is for a dental material (calcium hydroxide paste), not an AI device.

Let's break down what can be extracted and what cannot, based on the provided text, in the context of your request for an AI device.

Observation: The provided document describes a medical device (a dental calcium hydroxide paste called "CleaniCal"), not an AI-powered device. Therefore, many of the questions related to AI-specific study designs (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size) will not be addressed in this document.

However, I will interpret the request as best as possible using the available information, mapping it to your bullet points where applicable, and highlighting where information is not present for this type of device.

Acceptance Criteria and Device Performance for CleaniCal (a Dental Material)

The acceptance criteria for "CleaniCal" are primarily defined by its ability to meet established ISO standards for dental root canal filling materials and its biocompatibility. The study proving the device meets these criteria is a series of non-clinical (bench and biocompatibility) tests.

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

The document states: "All the test results met the preset test criteria." The "preset test criteria" are the specific requirements within the referenced ISO standards. The table below summarizes the types of tests performed and the general outcome as stated in the document. Specific numerical acceptance values or reported performance metrics for each test (e.g., exact flow rate, specific radio-opacity value) are not provided in this 510(k) summary, only that the device "met" them.

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

• Sample Size for Test Set: Not explicitly stated in the document. For non-clinical bench testing, sample sizes are typically determined by relevant ISO standards or internal quality procedures.
• Data Provenance: The testing institution is MARUCHI itself (the manufacturer) or external labs contracted by MARUCHI, as implied by "Testing institution's method." The country of origin for the testing would likely be Republic of Korea as that is where MARUCHI is located. These are non-clinical, pre-market tests, so the retrospective/prospective distinction for clinical data doesn't apply here.

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

• Not Applicable. For this type of dental material, "ground truth" is established by adherence to specified physical, chemical, and biological properties as defined by international standards (e.g., ISO 6876, ISO 10993). This does not involve clinical "experts" in the sense of radiologists reading images to establish ground truth for diagnostic AI. The tests are laboratory-based measurements.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy assessments where human readers interpret data that AI might also interpret. The tests performed for CleaniCal are objective laboratory measurements, not subjective evaluations 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:

• Not Applicable. This is not an AI-powered device. Therefore, no MRMC study, AI assistance comparison, or effect size calculation with human readers was performed or is relevant.

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

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

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

• For CleaniCal, the "ground truth" is based on objective measurements of material properties and biological responses as defined by international standards (ISO 6876, ISO 10993 series). This includes properties like pH, flow, radio-opacity, and results of various biocompatibility tests (cytotoxicity, systemic toxicity, genotoxicity, implantation). It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not Applicable. This is not an AI-powered device. There is no "training set" in the context of machine learning.

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

• Not Applicable. This is not an AI-powered device. There is no "training set" or "ground truth establishment" for a training set.

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1. Pulp capping agent
2. Liner

Resin modified light cure pulp capping material / liner (indications from labeling).

This document is a 510(k) Pre-Market Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to a previously cleared predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the requested information (1-9) about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided directly from the given text. The document describes a comparison to a predicate, not a performance study against predefined acceptance metrics for the new device.

However, I can extract information related to the device comparison and the basis of the substantial equivalence claim.

Here's what can be inferred or directly stated from the provided text, while acknowledging the limitations regarding a "study that proves the device meets the acceptance criteria" in the traditional sense of a performance study:

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

• Acceptance Criteria (Implicitly based on Predicate Equivalence): The document implies that the "acceptance criteria" for the new device, LC ResinCal PC, are that its performance and characteristics are "substantially equivalent" to the predicate device, TheraCal LC (Bisco). While explicit numerical acceptance criteria for a new performance study are not given, the goal is to match or be comparable to the predicate.
• Reported Device Performance (Comparative): The performance is reported in terms of similarities to the predicate across various attributes.

• Liner | - Pulp capping agent
• Liner | Same |
  | Ingredients (General) | - Portland cement
• Photo initiators
• Resins (e.g. BIS-GMA*) | - Portland cement
• Photo initiators
• Resins (e.g. BIS-GMA*) | Very similar (stated as "general chemical composition... very similar") |
  | Working Properties | (Not explicitly detailed, but implied to be similar) | (Not explicitly detailed, but implied to be similar) | Very similar (intensity, wavelength, curing time) |
  | Physical Properties | (Not explicitly detailed, but implied to be similar) | (Not explicitly detailed, but implied to be similar) | Very similar (working time, depth of cure, barcol hardness, calcium release) |
  | Form of Delivery | black syringe | black syringe | Same |

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

• This document does not describe a clinical or lab "test set" in the context of performance testing for the new device with a specific sample size. The "test" here is a comparison to a predicate device based on its known characteristics and regulatory clearance.
• Data Provenance: The data provenance for the comparison is based on the characteristics of the predicate device (TheraCal LC, K063237, introduced to the US market in 2006) and the detailed chemical composition and properties of the subject device (LC ResinCal PC). No information on country of origin for specific "test data" is provided, nor whether it's retrospective or prospective.

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

• Not applicable in the context of this 510(k) summary. "Ground truth" in this document is effectively the established performance and safety profile of the predicate device, and the detailed specifications of the new device being compared. No experts were used to establish a "ground truth" for a test set in a diagnostic or clinical performance study.

4. Adjudication method for the test set

• Not applicable. There was no "test set" requiring adjudication in the context of a performance study. The "adjudication" is essentially the FDA's review and determination of substantial equivalence based on the provided comparative data.

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/imaging device, nor does the document describe any MRMC or comparative effectiveness study.

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

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

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

• The "ground truth" for the comparison is the established characteristics and regulatory clearance of the predicate device (TheraCal LC) as known and accepted by the FDA when it was cleared under K063237. For the new device, the "ground truth" of its properties is based on the manufacturer's internal testing and documentation of its chemical composition and physical properties.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device.

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Aqueous ointment material that temporarily fills the root canal for the following indications:

• Apexification
• Temporary root filling
• Root canal filling for primary teeth
• Vital pulpotomy
• Temporary pulp capping

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.

The provided text is an FDA 510(k) summary for a dental device called "Diapaste." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the information provided does not contain any data or discussion regarding the acceptance criteria and study proving a device meets performance criteria related to AI/ML or human-in-the-loop performance, as implied by the original question's structure. The document is a regulatory submission for a dental material (root canal filling resin), not an AI/ML powered medical device.

Therefore, I cannot extract the requested information (table of acceptance criteria with reported performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) because it is not present in the provided text.

The closest relevant sections in the document are about non-clinical performance data for the dental material itself, which are physical properties and biocompatibility tests, not AI/ML performance.

Here's an analysis of what is present in the document regarding performance:

1. A table of acceptance criteria and the reported device performance (for physical properties, not AI/ML):

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

• The document does not specify sample sizes for these performance tests.
• Data provenance is not mentioned (e.g., country of origin, retrospective/prospective). These are typical lab tests for material properties.

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

• Not applicable. These are physical property measurements, not data requiring expert interpretation or ground truth establishment in the context of diagnostic AI.

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

• Not applicable for physical property measurements.

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 device is a dental material, not an AI-powered diagnostic tool.

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

• Not applicable. This is not an algorithm.

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

• For physical properties, the "ground truth" is established by direct measurement against a standard (ISO 6876).
• For biocompatibility, the "ground truth" is established by laboratory tests against ISO standards (ISO 7405, ISO 10993 series).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

In summary, the provided document does not contain the information requested about AI/ML device performance. It is a regulatory clearance for a traditional medical device (a dental filling material), primarily demonstrating substantial equivalence through comparison of indications for use, composition, and conformance to relevant material-specific performance and biocompatibility standards.

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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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TheraCal DC is indicated for use for:

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

Not applicable. This is not an AI diagnostic device.

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

Not applicable. This is not an AI diagnostic device.

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

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

8. The sample size for the training set

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

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

Not applicable.

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TheraCal DC is indicated for use for:

• 1. Pulpotomy
• 2. Temporary filling material
• 3. Repair of root perforations
• Repair of furcation perforations 4.
• 5. Repair of perforating internal and external resorptions
• 6. Root-end filling in endodontic surgery
• 7. Pulp exposures (direct pulp capping)
• 8. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates

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

Here's a breakdown of the acceptance criteria and study information for the TheraCal DC device, extracted from the provided text:

Important Note: The provided document is a 510(k) summary for a dental material (TheraCal DC), not a software or AI-driven medical device. Therefore, many of the requested categories like "test set size," "ground truth experts," "adjudication method," "MRMC study," and "standalone performance" are not applicable in the context of this device and its regulatory submission. The information below reflects what is available in the document for a physical material.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. This document summarizes and compares physical/mechanical properties and biocompatibility, which typically involve laboratory tests on material samples rather than a "test set" in the sense of patient data.
• Data Provenance: Not specified. The tests are "in-house test method" or reference ISO/ANSI/ADA standards, suggesting laboratory testing. No information on country of origin or retrospective/prospective nature is relevant for this type of device.

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

• Number of Experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing methods, not expert consensus on interpretations.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Material property testing does not typically involve 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

• MRMC Study: No, this is not an AI-driven device.

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

• Standalone Study: No, this is not an AI-driven device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the performance data mentioned is established through standardized laboratory test methods (e.g., ISO, ANSI/ADA standards) and direct comparison to legally marketed predicate devices. For biocompatibility, it's defined by compliance with ISO standards (ISO 7405:2008 and ISO 10993-1:2009).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of a physical dental material. The material is developed and formulated based on scientific principles and then tested against established standards and predicate devices.

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

• How Ground Truth for Training Set Was Established: Not applicable.

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Life Fast Set/ Life Regular Set is a hard-setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.

Life Regular Set/Life Fast Set are hard setting Calcium Hydroxide cavity liners and pulp capping agents to be used in conjunction with all permanent restorative techniques. Life is a two-part, base/catalyst- paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Fast Set and Regular Set.

The provided document is a 510(k) premarket notification for a medical device called "Life Regular Set and Life Fast Set," which are calcium hydroxide cavity liners and pulp capping agents. It seeks to demonstrate substantial equivalence to a predicate device, "Life 2 (K012717)."

The document does not include the detailed information requested regarding specific acceptance criteria for device performance (e.g., accuracy metrics, thresholds), a study comparing the device against these criteria, or information on human reader studies, ground truth establishment with experts, or training set details for an AI/CAD system.

Instead, the document focuses on demonstrating substantial equivalence based on:

• Similarity in intended use and technological characteristics: The new device has the same intended use and a very similar formulation to the predicate. The primary difference in formulation is a change in the type of fumed silica, which is stated to be insignificant as it does not participate in the reaction.
• Manufacturing and packaging changes: The manufacturing location has changed, and the packaging material has been updated. These changes were validated internally.
• Non-clinical performance data: Verification and validation activities were performed according to design control requirements (21 CFR 820.30 and ISO 13485:2012) and risk analysis (ISO 14971:2012). The conclusion states these activities demonstrated substantial equivalence and that no new hazards were identified based on post-market data from the internationally sold product.

Therefore, I cannot provide the requested table or detailed information because the provided text does not describe a study that establishes acceptance criteria in terms of quantitative reported device performance for an AI/CAD system, nor does it detail a study proving the device meets distinct performance thresholds. The document's purpose is to demonstrate substantial equivalence to an existing device based on material, manufacturing, and packaging changes, supported by non-clinical validation and risk analysis, rather than a clinical performance study with specific metrics.

If this were an AI/CAD device, the requested information would be crucial. However, for this type of dental material, the FDA's review focuses more on the safety and efficacy of the formulation and manufacturing process, and its equivalence to a device already on the market.

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