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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.

Ask a specific question about this device

Biodentine™ is indicated to be used: In the crown: - 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 radicular lesions. - Pulp capping. - Pulpotomy. In the root: - Repair of root perforations. - Repair of furcation perforations. - Repair of perforating internal resorptions. - Repair of external resorption - Apexification. - Root-end filling in endodontic surgery (retrograde filling).

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Septodont regarding their device Biodentine. This document primarily focuses on the FDA's "substantial equivalence" determination for the device, its regulatory classification, and general compliance requirements.

It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. Therefore, I cannot extract the specific details you're asking for from this document.

Ask a specific question about this device

When used in the crown:

• Temporary enamel restorative material.
• Permanent dentine restorative material.
• Restoration of deep and/or large coronal carious lesions (sandwich technique).
• Restoration of deep cervical and/or radicular lesions.
• Pulp capping.
• Pulpotomy.

When used in the root:

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

Biodentine is not to be used for permanent obturation or sealing of the root canal

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and a study proving a device meets them. The text is a 510(k) premarket notification letter from the FDA to Septodont regarding their device Biodentine™. It discusses the regulatory approval of the device and its indications for use, but it does not detail any specific studies, acceptance criteria, or performance metrics.

Therefore, I cannot extract the requested information to fill in the table and answer the subsequent questions.

Ask a specific question about this device