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MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.

Device Description

MTA Fillapex is a mineral trioxide aggregate (MTA) and resin toot canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA-FILLAPEX is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation.

AI/ML Overview

The provided text describes the 510(k) submission for MTA Fillapex, a root canal sealer. It details performance criteria and tests conducted to demonstrate substantial equivalence to predicate devices, especially a modified version of K113568 with the addition of titanium dioxide to the base paste. However, this document does not describe a study, or acceptance criteria, for a device that uses AI. Instead, it's for a dental material (root canal sealer). Therefore, many of the requested fields related to AI/algorithm performance are not applicable.

Here's an analysis based on the provided text, focusing on the material it does describe:

1. Table of acceptance criteria and the reported device performance

Test Performed	Acceptance Criteria	Reported Device Performance (MTA Fillapex)	Source (pages)
Working time	23 minutes	23 minutes	2, 3
Setting time	130 minutes	Minimum 130 minutes (Table 1), 130 minutes (Table 2)	1, 3
Flow	Minimum of 20 mm	33.38 mm (Table 1)	1, 3
Radiopacity	Minimum of 3 mm	Greater than 3mm of the aluminium scale	3
Solubility	Maximum 3%	2.47% (Table 1)	1, 3
Internal Tests
Flow/Viscosity (Base Paste)	20-22 mm	Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product	1, 3
Flow/Viscosity (Catalyst Paste)	27-29 mm	Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product	1, 3
Flow/Viscosity (Mixed pastes after 30 min)	21-23 mm	Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product	1, 3
Radiopacity	Greater than 3mm of the aluminium scale	Greater than 3mm of the aluminium scale	3
Setting time	130 minutes	130 minutes	3
Free lime content	3-5%	Not explicitly stated in performance (only acceptance criteria)	3
Biocompatibility	Biocompatible	Biocompatible (based on prior K113568 testing)	1, 2
Shelf Life	2 years	2 years	1, 2

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 does not explicitly state the sample sizes used for each test beyond numerical results (e.g., "33.38 mm" for flow). The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective. The tests were performed as "Design Verification Tests" in response to a "Failure Modes and Effects Analysis (FMEA)" related to a modification (addition of titanium dioxide).

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)

Not applicable. This is for a dental material, not an AI/software device requiring expert ground truth for classification or diagnosis. Performance metrics are based on physical and chemical properties and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is for a dental material; there is no adjudication process involving multiple human readers for performance metrics like flow or setting time.

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 is for a dental material, not an AI device.

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

Not applicable. This is for a dental material, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical and chemical properties (flow, setting time, solubility, radiopacity, etc.), the "ground truth" is established by adherence to industry standards (specifically ISO 6876:2012) and established laboratory testing protocols. For biocompatibility, reliance is placed on previous testing for the predicate device (K113568) and the chemical composition.

8. The sample size for the training set

Not applicable. This is for a dental material, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is for a dental material, not an AI model.

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K Number

K132923

Device Name

FUSION SINGLE LINK

Manufacturer

ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA

Date Cleared

2014-01-03

(107 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K962785

Intended Use

Bonding all classes of direct composite restorations as well as for indirect procedures involving metal, porcelain, or composite crowns, inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.

Device Description

The Fusion Single Link by Angelus is a versatile system for dental bonding. It is a onebottle adhesive system, indicated for restorations, adhesive cementation of indirect restorations (cast metal, porcelain and composite resin veneers) and intraradicular posts (cast metal and prefabricated in metal or fiber). It can also be used for the bonding of orthodontic brackets, and for the repair of porcelain restorations.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Fusion Single Link device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate Device K962785 3M Dent System)	Reported Device Performance (Fusion Single Link)
Film thickness
Enamel adhesive layer	6.40 (2.80) µm	8.2 (2.40) µm
Dentin adhesive layer	4.22 (1.25) µm	8.4 (2.6) µm
Application Time	57 seconds	60 seconds
Light cure time	10 seconds	12 seconds
Bond to Dentin	45 MPa	37 MPa
Indications for Use	Bonding all classes of direct composite restorations, indirect procedures (metal, porcelain, composite crowns, inlays, onlays), amalgam, self-cure composite, orthodontic brackets to enamel, root desensitization.	Bonding all classes of direct composite restorations, indirect procedures (metal, porcelain, composite crowns, inlays, onlays), amalgam, self-cure composite, orthodontic brackets to enamel.

Note: The document states that "Based on performance data according the ISO/TS 11405: 2003, it was found that the average strength and average resistance of the two devices are substantially equivalent." This implies that despite some numerical differences, the overall performance is considered comparable for the purpose of substantial equivalence.

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

The document does not explicitly state the sample size used for the test set. It mentions "performance data" according to ISO/TS 11405: 2003, but not specific numbers of samples or cases.

The data provenance is not specified beyond being "performance data according the ISO/TS 11405: 2003". It doesn't indicate country of origin or whether it was retrospective or prospective.

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

This information is not provided in the document. The study relies on standardized testing methods (ISO/TS 11405: 2003) to measure bond strength and other properties, rather than expert-established ground truth in a clinical or imaging context.

4. Adjudication Method for the Test Set

Not applicable as the study uses objective measurements based on ISO/TS 11405: 2003, not expert review or consensus for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device to a predicate device based on material properties and bond strength, not on clinical interpretation or reading by human experts.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the device described. The device is a dental adhesive, not an algorithm or AI system. The performance data presented refers to the physical and chemical properties of the adhesive itself.

7. Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements of material properties and bond strength as defined by the ISO/TS 11405: 2003 standard. This standard provides guidelines for testing adhesion to tooth structure, including tensile and shear bond strength measurements.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set" in that sense. The study involves laboratory testing of material properties.

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

Not applicable, as points 8 explains.

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