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 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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