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In the crown:

For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):

• Permanent dentine restoration under composites or Inlay/Onlay

• Temporary dentine-enamel restoration;

• Restoration of deep and/or large coronal carious lesions (sandwich technique);

• Restoration of cervical or radicular lesions.

On the pulp:

For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):

• Pulp capping (direct and indirect).
• Pulpotomy for diagnosed symptoms of reversible pulpitis where bleeding is controlled within 5 minutes.

In the root:

For permanent teeth (immature or mature):

• Repair of root perforations;
• Repair of furcation perforations;
• Repair of perforating internal resorptions;
• Repair of external resorption;
• Root-end filling in endodontic surgery (retrograde filling).

For immature permanent teeth

• Apexification;

Biodentine™ XP 500, Biodentine™ XP 200 is a bioactive dentin substitute. The product is prepared from a mixture of a Biodentine™ XP 500, Biodentine™ XP 200 powder and a liquid. The product is presented in all-in-one cartridge containing thepowder phase and the liquid phase, ready to be mixed.

The medical device is presented in two presentations, the Biodentine™ XP 500 for the extraction of 500mg of finished product and the Biodentine™ XP 200 for the extraction of 200mg of finished product. The subject device is to be used with 2 accessories, the Biodentine™ Mixer and the Biodentine™ Gun.

The provided FDA 510(k) summary for Biodentine™ XP 500, Biodentine™ XP 200 describes a non-clinical study to demonstrate substantial equivalence to a predicate device, Biodentine™ (K140132). This submission does not include information about an AI/ML powered device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets the criteria in the context of an AI/ML device. The document explicitly states:

"No clinical data was collected using Biodentine™ XP 500. Biodentine™ XP 200 to support substantial equivalence between the subject and the predicate devices."

Instead, the submission relies on non-clinical (bench) testing and biological equivalence to the predicate device to demonstrate substantial equivalence.

Here's a summary of the non-clinical performance as described:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or target value format for each characteristic as it's a comparison to a predicate device. Instead, it compares the subject device's performance to the predicate device's performance, aiming for "Same" or "Similar" results.

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

• Sample Size: Not specified in the provided text. The document refers to "extensive bench testing" and "biological equivalence demonstrated."
• Data Provenance: Not explicitly stated. The testing was conducted to compare the Biodentine™ XP 500/200 to the Biodentine™ predicate device, presumably by the manufacturer, Septodont.

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

This information is not applicable to this submission, as it's a non-clinical, bench testing-based equivalence study, not a clinical study involving expert interpretation for ground truth.

4. Adjudication method for the test set:

Not applicable, as this was not a clinical study with image interpretation 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/ML device, and no MRMC study was conducted. The document explicitly states "No clinical data was collected."

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" or reference was likely established through standardized physical, chemical, and biological testing methods (e.g., ISO standards for dental materials) to measure properties like working time, setting time, compressive strength, pH, porosity, hardness, radiopacity, and biocompatibility. The performance of the predicate device also served as a reference for comparison.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, and no training set was used.

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

Not applicable. No training set was used.

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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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