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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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Use TheraCem to cement the following:

• 1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
• 2. Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
• 3. Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
• 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
• 5. Implant supported restorations
• 6. Orthodontic Appliances (brackets, bands)

TheraCem is a self-etching, self-adhesive, dual-cured resin luting cement that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and nonmetal/fiber posts, as well as cast posts). TheraCem is a paste/paste, fluoride- and calciumreleasing, luting cement which requires no etching, no priming or bonding of the prepared surfaces. It is easy-to use, requires only a short chair time, and produces a good bond to most dental materials. The cement is available in a Natural shade. It is radiopaque, allowing for easy identification on radiographs.

The provided text is a 510(k) summary for the dental cement TheraCem. It describes the device, its indications for use, technological characteristics, and performance data, but it does not contain the information you're looking for regarding acceptance criteria and study details for an AI/CADe device.

Specifically, the document focuses on demonstrating substantial equivalence to predicate dental cements based on physical and mechanical properties, not on AI-assisted diagnostic or decision-making capabilities. Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: The document provides a table of physical/mechanical properties tested for TheraCem and states its equivalence to predicates or compliance with ISO standards, but these are not "acceptance criteria" in the context of an AI device's diagnostic performance (e.g., sensitivity, specificity, AUC).
2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
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: For a dental cement, "ground truth" would relate to its physical properties (e.g., bond strength, setting time), which are measured according to established standards (e.g., ISO).
8. The sample size for the training set: Not applicable, as there's no AI model being trained.
9. How the ground truth for the training set was established: Not applicable.

The document is for a medical device (dental cement) that does not involve AI or diagnostic imaging. The performance data presented is about the product's physical and chemical characteristics, which are compared to predicate devices for substantial equivalence.

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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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