Search Results

-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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• 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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