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i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications.

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

i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a ready-to-use premixed bioceramic paste developed for permanent root canal sealer and repair and surgical applications. i-MTA 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. i-MTA BP does not shrink during setting and demonstrates excellent physical properties. i-MTA BP is packaged in a preloaded syringe.

Here's a breakdown of the acceptance criteria and the study details for the Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP), based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore, some of the requested information (like effect size of human readers with vs. without AI, number of experts for ground truth, adjudication methods, details on training set) are not applicable. The information provided relates to a traditional medical device's performance against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific performance test (e.g., how many samples were tested for setting time, solubility, etc.). The provenance of the data is not specified beyond being generated from "Performance testing - Bench" and "Biocompatibility Testing" which implies laboratory testing directly on the subject device. There is no indication of retrospective or prospective clinical data from specific countries for these bench tests.

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

This information is not applicable to the type of device and testing presented. The "ground truth" for this device is based on objective measurements against international and technical standards, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined criteria, not subjective interpretation requiring adjudication among experts.

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 for diagnostic imaging devices where human readers interpret medical images. This device is a dental material, and its performance is evaluated by bench testing and biocompatibility.

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

Yes, the device's performance was evaluated in a standalone manner (without human-in-the-loop performance) through bench testing and biocompatibility studies. As it is a physical material, there is no "algorithm" involved, but its intrinsic properties were tested directly.

7. The Type of Ground Truth Used

The ground truth used for performance validation is objective measurement against established international standards (e.g., ISO 6876:2012, ISO 10993 series, ISO 7405:2018) and internal Technical Specifications.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of 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.

i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and placement of intracanal dressings.

i-MTA SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. an injectable mineral trioxide aggregate. i-MTA SP is used for root canal sealing and permanent obturation. It is an insoluble and radiopaque material based on a calcium silicates composition, which requires the presence of water to set and harden. i-MTA SP is packaged in an oral irrigator and is supplied with disposable Intra Canal Tips. i-MTA SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.

The provided text describes a 510(k) submission for a medical device, the "Injectable Root Canal Bioceramic Sealer (i-MTA SP)". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with AI or human readers.

Therefore, the requested information regarding acceptance criteria, AI/human reader performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies is not available in the provided text.

The text primarily details:

• Device Name: Injectable Root Canal Bioceramic Sealer (i-MTA SP)
• Regulation Number: 21 CFR 872.3820
• Regulation Name: Root Canal Filling Resin
• Product Code: KIF
• Indications for Use:
  • 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.
  • Suitable for use in the single cone and placement of intracanal dressings.
• Comparison to Predicate Devices: The document explicitly states its purpose is to show "substantial equivalence" based on "similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices."
• Performance Data Provided:
  • ISO 6876:2012 Dentistry - Root canal sealing materials.
  • Endodontic usage Test- ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
  • Biocompatibility Assessment per FDA Biocompatibility Guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

No information about AI performance, human reader studies, or the specific criteria for such studies is present in this 510(k) summary. This device is a material used for root canal filling, not a diagnostic or AI-powered device.

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