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 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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