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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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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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Root canal sealers solvent when canal retreatment is required.

ENDOSOLV (new device, K172839/S001) is a solvent used for eugenate-type or phenolic resin-based endodontic cements in the context of endodontic retreatment. This solvent is able to soften conventional zinc oxide eugenol cements and phenolic resin type sealers in the context of endodontic retreatment. It is indicated for use as a root canal sealer solvent when canal retreatment is required. ENDOSOLV (new device, K172839/S001) composition consists of ethyl acetate, amyl acetate and thymol. Ethyl acetate and amyl acetate are the two main components of the formulation that are effective in dissolving zinc oxide-eugenol-based and resin based filling material.

The provided text describes the 510(k) premarket notification for ENDOSOLV (K172839) and compares it to a predicate device, ENDOSOLV E (K980633). The study focuses on demonstrating substantial equivalence, primarily through performance testing of the new device's ability to dissolve root canal sealers.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "must dissolve within X seconds"). Instead, the performance studies aim to show that the new device, ENDOSOLV, is "as effective as" or "comparable to" the predicate device, ENDOSOLV E, and a positive control (ENDOSOLV R) in softening root canal sealers.

Therefore, the reported device performance is framed as a comparison to the predicate and positive control.

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

• Sample Size for Performance Testing: Not explicitly stated. The tables provide softening times for different types of cements, suggesting multiple tests were performed for each, but the exact number of samples or replicates for each test is not provided.
• Data Provenance: The performance testing was performed by Septodont, the manufacturer. No information on the country of origin of the data or whether it was retrospective or prospective is provided beyond the location of the study site (Septodont itself did the performance testing, biocompatibility was outsourced to Envigo and Phycher).

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

Not applicable. The performance testing involves direct measurements of softening time for root canal sealers, not interpretation by human experts. Biocompatibility testing follows ISO standards and lab protocols.

4. Adjudication Method for the Test Set

Not applicable, as the tests involve objective measurements (softening time) and standardized biocompatibility assays, not expert interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study is for a medical device (solvent) and involves laboratory performance testing (softening time) and biocompatibility, not an imaging or diagnostic device requiring human reader analysis.

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

Not applicable, as the device is a chemical solvent and does not involve an algorithm. Performance is assessed directly through its chemical and physical properties.

7. The Type of Ground Truth Used

The ground truth for the performance testing is the objectively measured "softening time" of various root canal sealers when exposed to the solvent. For biocompatibility, the ground truth is established by the results of standardized ISO 10993 tests (cytotoxicity, hypersensitivity, irritation).

8. The Sample Size for the Training Set

Not applicable. This device is a chemical solvent, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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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.

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"BPA-Free Pit and Fissure Sealant" is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.

Not Found

I'm sorry, but without further context, I cannot fulfill your request. The provided text is a letter from the FDA regarding a premarket notification for a medical device (BPA-Free Pit and Fissure Sealant); it does not contain information about acceptance criteria or a study that proves the device meets those criteria.

To help you, I would need a document that describes:

• The specific acceptance criteria for the device (e.g., performance metrics, thresholds).
• Details of a study conducted to evaluate the device against these criteria.
• Information about the study's methodology, sample size, ground truth establishment, and expert involvement.

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Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure an d core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

Not Found

This document is largely a 510(k) clearance letter from the FDA for two dental devices, Granitec® Dual-Cure Core Build-Up and N'Durance Dimer Core. It states that the devices are substantially equivalent to legally marketed predicate devices.

The letter itself does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory approval document based on a finding of substantial equivalence, not a detailed report of performance testing.

Therefore, I cannot provide the requested information from the provided text. The document outlines the FDA's decision based on a review of the manufacturer's submission, but the details of the performance study and acceptance criteria are not included in this letter.

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Racegel™ is a gel containing aluminium chloride which is intended for sulcus retraction prior to impression taking; control of bleeding and gingival oozing, particularly in restorative dentistry; and, if using a gingival retraction cord, the gel facilitates the insertion of the cord into the sulcus.

Racegel™ is a gel containing aluminium chloride.

The provided document is an FDA 510(k) clearance letter for a dental product called Racegel™. This document does not describe acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a regulatory document stating that the product is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory approval and indications for use, not on performance studies or acceptance criteria comparisons.

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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.

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RTR® SYRINGE is designed for the replacement of bone losses, after being impregnated with the patient's blood or with a physiological solution for craniofacial indications in the dental practice such as filling tooth sockets.

Not Found

The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "RTR® Syringe." It does not contain information about acceptance criteria, device performance studies, or clinical trial data. The document primarily focuses on regulatory approval and the device's indications for use.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
3. Information on MRMC comparative effectiveness studies or standalone performance.
4. Type of ground truth, training set sample size, or how ground truth was established for a training set.

This document is a regulatory approval, not a scientific study report.

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The intended use for SECURALLOY dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 70 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 50 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for dental amalgam devices. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

The document states that the devices (Securalloy, Septalloy NG 50, and Septalloy NG 70) are "substantially equivalent" to legally marketed predicate devices, which is the basis for their clearance. It does not describe performance acceptance criteria or a study with specific metrics, sample sizes, or ground truth methodologies as would be expected for a detailed performance evaluation.

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