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• Permanent obturation of the root canal following vital pulp-extirpation
• Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.

The provided text is a 510(k) summary for a dental device (iRoot SP Plus), specifically a root canal filling resin. It addresses the substantial equivalence to a predicate device based on non-clinical tests and the predicate device's clinical history.

However, the document does not contain information about acceptance criteria or a study proving that an AI/ML-based device meets acceptance criteria.

The request asks for information related to an AI/ML device's performance, such as:

1. A table of acceptance criteria and reported device performance (for an AI/ML device)
2. Sample sizes and data provenance for an AI/ML test set
3. Number and qualifications of experts for AI/ML ground truth
4. Adjudication method for AI/ML test set
5. MRMC study details and effect size for AI assistance
6. Standalone performance of an AI algorithm
7. Type of ground truth used for an AI/ML device
8. Sample size for AI/ML training set
9. How ground truth for AI/ML training set was established

Since the provided text is for a root canal filling resin and not an AI/ML device, none of the requested information regarding AI/ML device performance and testing is present. The document focuses on chemical composition, physical properties, and equivalence to existing root canal sealers.

Therefore, I cannot provide the requested details based on the given input.

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-Repair of Root Perforation
-Repair of Root Resorption
-Root End Filling
-Apexification
-Pulp capping
-Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages >12-21 years).

iRoot BP, iRoot FS, and iRoot BP Plus are a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste. Which are developed for permanent root canal repair of root perorption, and root end filling, apexification and pulp capping applications in adult and pediatric cases. The aforementioned products are an insoluble, radiopaque and aluminum-free material based on a calcium slicate composition, which requires the presence of water to set and harden. The products do not shrink during setting and demonstrate excellent physical properties. Root BP is packaged in a preloaded syringe, iRoot BP Plus is packaged in a preloaded container and iRoot FS is available both in syringe and container form. The devices have not changed from their respective predicate devices of iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867).

Regarding iRoot BP Root Repair Material BioAggregate Paste, iRoot FS Fast Set Root Repair Material, and iRoot BP Plus Root Repair Material:

The provided text does not include acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested. Instead, it is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, with an emphasis on adding an indication for pulpotomy in pediatric patients.

However, based on the provided text, I can infer some aspects and extract information relevant to your inquiry, particularly regarding the rationale for introducing a new indication:

Inferred Acceptance Criteria (for the new pediatric pulpotomy indication):

While explicit numerical acceptance criteria are not stated for this particular submission, the underlying acceptance criteria for the new indication are implied to be demonstrable equivalence in safety and effectiveness to the primary predicate device, ProRoot MTA (K142178), for pulpotomy in pediatric populations. This equivalence is asserted through reliance on existing independent third-party, peer-reviewed published medical literature.

Reported Device Performance:

The device performance is not reported in terms of specific metrics like sensitivity or specificity. Instead, the document asserts that:

• The devices (iRoot BP, iRoot BP Plus, iRoot FS) are "identical to their corresponding predicate devices" in their technological characteristics.
• They "still strictly abide by the ISO 6876 and ANSI/ADA No. 57".
• "many independent third-party studies that have been performed on Root BP and iRoot BP Plus which show their equivalence to MTA(K142178) for the purposes of pediatric applications as well as their safety and effectiveness in that specific use."
• The conclusion is that the proposed devices are "both safe and effective as well as performing as well if not better then MTA(K142178)."

Therefore, a table of acceptance criteria and reported performance in the requested format cannot be directly created from the provided text for this specific submission. The submission relies on existing data and prior clearances.

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

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

• Sample Size: Not specified for any particular test set within this document. The submission relies on "many pieces of independent third-party, peer-reviewed published medical literature."
• Data Provenance: The studies are from "independent third-party, peer reviewed published medical literature." The origin countries are not specified, nor is whether they are retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Not 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, this is not an AI-assisted device and therefore no MRMC study involving human readers with/without AI assistance was performed or described. The device is a root repair material (bioceramic paste), not a diagnostic imaging or AI tool.

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

• No, this information is not applicable. The device is a physical material, not an algorithm.

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

• The ground truth for the "many independent third-party studies" cited would likely involve clinical outcomes data from treating pediatric pulpotomy cases, potentially with histological evaluation or other clinical measures accepted in dental research for assessing treatment success. The specific nature of the ground truth is not detailed in this submission summary.

8. The sample size for the training set:

• Not applicable / Not specified. The device is a physical material, not a "trained" algorithm in the machine learning sense. The referenced studies are clinical studies, not machine learning training sets.

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

• Not applicable / Not specified. As above, this is not a machine learning submission. The "ground truth" for the clinical literature would be established through standard clinical trial methodologies and outcome assessments for dental procedures.

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For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

These indications include application in:

• Apexification
• Periapical Lesions
• Root Resorption ●
• Temporary Root Filling ●
• Perforations ●
• Underdeveloped pulpless teeth ●

iRoot FM Injectable Root Canal Filling Material (iRoot FM) is a convenient premixed ready-to-use injectable, radiopaque, white hydraulic bioceramic paste developed for root canal filling applications. iRoot FM is an aluminum-free material based on a calcium silicate composition, which requires the presence of water to set. iRoot FM is packaged in a pre-loaded syringe and is supplied with disposable tips.

This document is a 510(k) premarket notification for the iRoot FM Injectable Root Canal Filling Material. The provided text, however, does not describe the acceptance criteria or a specific study that proves the device meets those criteria in the typical format of a clinical or analytical performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments.

Here's a breakdown of the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of this submission document:

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

Notes on the table:

• Acceptance Criteria: These are inferred from the types of tests performed. The document states "iRoot FM has undergone extensive bench and biocompatibility NON-CLINICAL TESTS testing to provide evidence that iRoot FM's chemical and physical properties are substantially equivalent to iRoot SP." Specific quantitative thresholds for "acceptance criteria" are not given in this summary; rather, the performance is reported as meeting the criteria because it was found to be "substantially equivalent" to the predicate device, iRoot SP.
• Reported Device Performance: This column reflects the conclusions drawn from the non-clinical tests.

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 for Test Set: Not specified for the bench tests or biocompatibility tests.
• Data Provenance: Not specified. The submission is from Innovative BioCeramix Inc. in Vancouver, BC, Canada, but the origin of the test data (e.g., where the tests were conducted) is not provided. The study appears to be entirely non-clinical bench testing, not a clinical study.

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)

• Number of Experts: Not applicable. This was a non-clinical bench study, not a study involving expert readers to establish ground truth from clinical data.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This was a non-clinical bench study.

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 Comparative Effectiveness Study: No, this was not a MRMC study. The device is a root canal filling material, and the evaluation was based on non-clinical bench testing and biocompatibility, not on human reader performance with or without AI assistance.

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

• Standalone Performance Study: Not applicable. This device is a material, not an algorithm.

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

• Type of Ground Truth: Not applicable in the context of clinical "ground truth." For the non-clinical tests, the "ground truth" was established based on standard material testing methods and biocompatibility assays, comparing the results to those expected for a substantially equivalent device or predicate device (iRoot SP, iRoot FS, BioAggregate, and Diapex).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This was a non-clinical evaluation of a material, not a machine learning model requiring a training set.

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

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

In summary, the provided document details a 510(k) submission focused on demonstrating substantial equivalence of the iRoot FM Injectable Root Canal Filling Material to existing predicate devices (iRoot SP, iRoot FS, BioAggregate, Diapex) through non-clinical bench testing (flow, working time, setting time, radiopacity) and biocompatibility assessments. It does not describe a clinical study with human subjects, expert readers, or AI performance evaluation.

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• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

iRoot FS Fast Set Root Repair Material (iRoot FS) is a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. iRoot FS is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot FS does not shrink during setting and demonstrates excellent physical properties. iRoot FS is available as a preloaded syringe with disposable tips and a preloaded container.

This document is a 510(k) summary for the iRoot FS device, a root canal repair material. The submission aims to demonstrate substantial equivalence to predicate devices, namely iRoot BP, iRoot BP Plus, iRoot SP, and D-PBS.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This submission does not provide explicit numerical "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating substantial equivalence in chemical and physical properties, and biocompatibility to existing predicate devices.

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

The document does not describe a "test set" in the context of a clinical trial or a diagnostic device where a sample size of patient data would be relevant. The testing performed was "shelf life, bench and biocompatibility testing."

• Sample Size for Test Set: Not applicable in the context of clinical data for a diagnostic device. For bench testing, typical laboratory sample sizes would be used, but these are not specified in the summary.
• Data Provenance: The nature of the bench and biocompatibility testing means the data is likely generated in a laboratory setting, not from patient populations. No country of origin for such data is stated, nor is it specified if it's retrospective or prospective, as these terms usually apply to clinical studies.

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

This information is not provided as the submission focuses on non-clinical testing and substantial equivalence, not clinical performance or diagnostic accuracy validated by experts.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a diagnostic test set 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 type of study is typically performed for diagnostic imaging devices to evaluate human reader performance with and without AI assistance. This submission describes a dental material, not a diagnostic device.

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

No, a standalone algorithm performance study was not done. The device itself is a material for dental procedures, not an algorithm.

7. The Type of Ground Truth Used

For the "test set" (bench and biocompatibility testing), the "ground truth" would be the established scientific and regulatory standards/methods for evaluating chemical properties, physical properties (e.g., flow, setting time, solubility, dimensional change), and biocompatibility (e.g., cytotoxicity, mutagenicity, sensitization, tissue irritation). These are determined through standardized laboratory protocols and scientific literature, not clinical ground truth like pathology or outcomes data in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

Not applicable. The iRoot FS is a physical dental material, not an AI algorithm, so there is no "training set."

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

Not applicable. As there is no AI algorithm, there is no training set or associated ground truth establishment process.

In summary, this 510(k) submission for iRoot FS focuses entirely on demonstrating substantial equivalence to predicate devices through non-clinical (shelf life, bench, and biocompatibility) testing, rather than reporting on clinical performance or diagnostic accuracy assessed via expert review or human-in-the-loop studies. Therefore, most of the questions related to clinical study design, expert involvement, and AI performance are not applicable to the information provided in this document.

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• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

iRoot BP Plus Root Repair Material (iRoot BP Plus) is a convenient ready-to-use white hydraulic premixed bioceramic paste developed for permanent root canal repair and surgical applications. iRoot BP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP Plus is packaged in a preloaded container.

The provided text describes a 510(k) summary for the iRoot BP Plus Root Repair Material. This submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical (bench and shelf life) testing, rather than a clinical study with acceptance criteria and device performance metrics in the typical sense of diagnostic performance (e.g., sensitivity, specificity).

Therefore, the requested information elements related to clinical study design, ground truth, expert consensus, and reader performance are not applicable in this context. The acceptance criteria here would be demonstrating equivalent chemical, physical properties, and performance specifications through bench and shelf-life testing.

Here's an adaptation of the requested table and information based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to a 510(k) for substantial equivalence based on non-clinical data):

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

   • Test Set: Not applicable in the context of a clinical test set with human or patient data. The "test set" here refers to the iRoot BP Plus product itself undergoing bench and shelf-life testing. The sample size for these non-clinical tests is not specified, but it would have involved multiple samples of the material.
   • Data Provenance: The data is from non-clinical (bench and shelf-life) testing conducted by the manufacturer, Innovative BioCeramix Inc. The location of the testing is not specified, but the company is based in Vancouver, BC, Canada. This is not retrospective or prospective clinical data.

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

   • Not applicable. Ground truth in this context refers to the measured chemical, physical, and performance properties of the materials themselves, established through laboratory testing, not expert interpretation of clinical data.

3. Adjudication method for the test set:

   • Not applicable. There was no clinical test set requiring adjudication.

4. 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 was a 510(k) for a root repair material, not an AI-assisted diagnostic device.

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

   • Not applicable. This was a 510(k) for a root repair material, not an algorithm.

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

   • The "ground truth" (or reference standard) for this submission consisted of the known chemical compositions, physical properties, and performance specifications of the predicate device (iRoot BP) and other materials (BioAggregate, Cavit-W, VitalCare I.V. Administration Set), established through validated laboratory methods and existing regulatory approvals.

7. The sample size for the training set:

   • Not applicable. There was no "training set" in the machine learning sense for this medical device submission. The device itself (iRoot BP Plus) was developed based on existing knowledge and materials (the predicate devices).

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

   • Not applicable, as there was no training set in the machine learning sense. The "ground truth" for the development of iRoot BP Plus would be the established scientific and engineering principles for dental materials and the properties of its predecessor and other predicate devices.

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• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

iRoot BP Injectable Root Canal Repair Filling Material (iRoot BP) is a convenient ready-to-use white hydraulic premixed injectable BioAggregate paste developed for permanent root canal repair and filling applications. iRoot BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP is packaged in a preloaded syringe and is supplied with disposable tips.

The device in question, iRoot BP Injectable Root Canal Repair Filling Material, is a dental product and theprovided text describes its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific clinical acceptance criteria in the way an AI/ML device would.

Therefore, the following information is not applicable or not provided in the given text:

• Acceptance criteria and reported device performance in a table (as this is not an AI/ML device with quantifiable performance metrics like accuracy, sensitivity, etc.).
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance (without human-in-the-loop).
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the documentation focuses on non-clinical tests to establish substantial equivalence.

Here's an analysis of the provided information, framed as closely as possible to your request, while acknowledging the limitations for a non-AI/ML device:

Device: iRoot BP Injectable Root Canal Repair Filling Material

1. Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are generally related to demonstrating substantial equivalence to existing predicate devices through comparable chemical, physical, and biocompatible properties, as well as similar performance specifications. The "reported device performance" are the results of these non-clinical tests compared to the established properties of the predicates.

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

This information is not provided in the document. The testing described is primarily laboratory bench testing and biocompatibility assessment, not a clinical trial with a "test set" in the context of patient data.

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

This is not applicable as the evaluation is based on non-clinical laboratory tests and established properties of predicate devices, not expert interpretation of clinical cases.

4. Adjudication Method for the Test Set

This is not applicable, as there isn't a test set requiring expert 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 device is not an AI/ML system and does not involve human readers for interpretation.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For physio-chemical properties and performance specifications, the "ground truth" is derived from established standards for dental materials and the known, FDA-accepted properties of the predicate devices (BioAggregate, iRoot SP, Jeltrate® Plus™ Impression Material, Clearfil™ Ceramic Primer).
For biocompatibility, the "ground truth" comes from standard biocompatibility testing protocols and the established safety profiles of the chemical components present in the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set for machine learning.

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

Not applicable. There is no training set mentioned or implied for this device.

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• Permanent obturation of the root canal following vital pulp-extirpation.
• Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
  iRoot SP is suitable for use in the single cone and lateral condensation technique.

iRoot SP Root Canal Sealer (iRoot SP) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP does not shrink during setting and demonstrates excellent physical properties. iRoot SP is packaged in a pre-loaded syringe and is supplied with disposable Intra Canal Tips.

The provided text describes the iRoot SP Root Canal Sealer and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for device performance or the study that proves these criteria are met in the way typically associated with AI/ML medical devices (e.g., diagnostic accuracy metrics).

Instead, this document focuses on demonstrating substantial equivalence through a comparison of physical, chemical, and biocompatible properties with established predicate devices. The "studies" mentioned are non-clinical bench and biocompatibility tests.

Therefore, many of the requested sections (sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission for a traditional medical device like a root canal sealer.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the physical-chemical properties of the predicate devices. The "reported device performance" refers to the results of the non-clinical tests demonstrating that iRoot SP's properties are comparable to these predicates.

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

• Sample Size for Test Set: Not applicable in the context of human data or AI model output. The "test set" here would refer to the samples used in bench and biocompatibility testing, but specific numbers are not provided.
• Data Provenance: The tests are non-clinical (bench and biocompatibility). The chemical composition is based on BioAggregate, and its biocompatibility data is referenced. This implies laboratory testing on materials, not patient data from specific countries.

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

• This is not applicable as the "ground truth" for a root canal sealer is its physical, chemical, and biocompatible properties, not a diagnostic interpretation by human experts.

4. Adjudication method for the test set

• Not applicable as there is no human interpretation or diagnostic labeling process.

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. iRoot SP is a physical material (root canal sealer), not an AI/ML diagnostic or assistive device.

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

• Not applicable. iRoot SP is a physical material, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is the established physical, chemical, and biocompatibility profiles of legally marketed predicate devices (AH® Plus™ Root Canal Sealer, BioAggregate, Apexit® Root Canal Sealer, Exactech Resorbable Bone Paste, MBCP Gel™, Diapex®). The performance of iRoot SP was compared to these established profiles.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device requiring a training set of data.

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

• Not applicable as this is not an AI/ML device.

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Repair of Root Perforations
Repair of Root Resorption
Root End Filling
Apexification
Pulp capping

BioAggregate is a white hydraulic cement-like powder composed of biocompatible ceramic particles. The BioAggregate Powder promotes cementogenesis upon mixing with BioA Liquid and forms a hermetic seal inside the root canal.

This document describes the 510(k) summary for BioAggregate, a root canal repair filling material. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your questions:

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

The document does not explicitly state "acceptance criteria" in a table format with numerical targets. Instead, it describes a comparison to a predicate device (WHITE MTA MATERIAL) and other predicate devices for specific chemical compounds. The performance is assessed based on substantial equivalence in various properties.

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

The document describes "extensive bench and biocompatibility testing" but does not specify the sample sizes (e.g., number of units tested for working time, number of animals/cells for biocompatibility). The data provenance (country of origin, retrospective/prospective) is not provided. It's implied these are laboratory (bench) tests and biocompatibility studies.

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)

This section is not applicable as the study is not based on expert-established ground truth on clinical images or patient outcomes. The evaluation is against established properties of a predicate device and chemical safety/effectiveness.

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

This section is not applicable for the same reason as point 3.

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

This section is not applicable. This submission is for a dental filling material, not an AI-powered diagnostic or assistive device.

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

This section is not applicable. This is a material, not an algorithm.

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

The "ground truth" for the non-clinical tests is essentially the established and accepted properties of the predicate device (WHITE MTA MATERIAL) and scientific consensus on the safety and effectiveness of specific chemical compounds found in the additional predicate devices. For biocompatibility, it's based on standard biological evaluation tests (e.g., ISO 10993 series).

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This section is not applicable. There is no "training set" or corresponding ground truth establishment in this context.

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