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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.

AI/ML Overview

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.

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Devices)	Reported Device Performance (Summary of Non-Clinical Test Results)
Equivalent chemical composition to predicate devices BioAggregate, iRoot SP, Jeltrate® Plus™ Impression Material, and Clearfil™ Ceramic Primer.	iRoot BP's main chemical composition is based on BioAggregate. Additional chemical components are found in iRoot SP, Jeltrate® Plus™ Impression Material, and Clearfil™ Ceramic Primer, which are deemed safe and effective.
Comparable physical properties to BioAggregate (flow, working time, setting time, dimensional change following setting, solubility, radiopacity).	Bench tests for iRoot BP included flow, working time, setting time, dimensional change following setting, solubility, and radiopacity, and demonstrated comparability to BioAggregate and iRoot SP.
Comparable biocompatibility properties (non-cytotoxic, non-mutagenic, no allergenic potential, good tolerance by subcutaneous tissue) to BioAggregate and iRoot SP.	iRoot BP was determined to be non-cytotoxic. Biocompatibility data from BioAggregate and iRoot SP (chemical components are shared) provided evidence that iRoot BP is non-mutagenic, does not cause an allergenic potential after multiple uses, and has good subcutaneous tissue tolerance.
Similar delivery system to iRoot SP.	iRoot BP has a comparable delivery system to iRoot SP (preloaded syringe with disposable tips).
Same indications for use as predicate devices.	iRoot BP has the same indications for use as specified for predicate devices (Repair of Root Perforation, Repair of Root Resorption, Root End Filling, Apexification, Pulp Capping).

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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