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The SmartMTA Capsule is indicated for use as:

• Orthograde root canal filling material
• Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
• Repair of root canals as an apical plug during apexification
• Root end filling
• Pulp capping
• Pulpotomy/Partial Pulpotomy

The major compositions of the SmartMTA Capsule are Calcium Carbonate (CaCO3), Silicon Dioxide (SiO₂), Aluminum Oxide (Al₂O₃), Zirconium Oxide (ZrO₂) and Distilled water and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water and is used in a putty form which gradually hardens in the oral environment. SmartMTA Capsule is ideal for orthograde root canal filling. SmartMTA Capsule is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not mentioned.

Device Name: SmartMTA Capsule
Predicate Device: RetroMTA-OrthoMTA II (K132825)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" for the device in the typical sense of a target performance threshold that must be met. Instead, it compares the SmartMTA Capsule's performance to the predicate device and relevant ISO standards, explaining deviations. The key performance metrics and their reported values are derived from the ISO 6876:2012 standard testing where applicable.

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

• Sample Size for Test Set: Not explicitly stated for each specific test (Flow, Working Time, etc.). The mention of "candidate device 200/160" and "candidate device 200/140" implies at least two different mix ratios were tested for the SmartMTA Capsule, and for some tests, multiple measurements were taken (e.g., 4.33mm and 4.4mm for Radiopacity). However, the number of samples per test is not provided.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The testing seems to be bench (non-clinical) testing.

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

• Experts for Ground Truth: Not applicable for the non-clinical, bench testing described. The "ground truth" (or target performance) was established by the ISO 6876:2012 standard.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for the non-clinical, bench testing described.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The document states: "There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device."
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study or AI component is mentioned.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI is not applicable. The device is a physical root canal filling material. The non-clinical tests assess the material's properties directly.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the "ground truth" was the ISO 6876:2012 standard for root canal sealing materials. The document also refers to the predicate device's performance as a comparison point.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

Summary of the Study:

The provided document describes a non-clinical bench testing study comparing the SmartMTA Capsule to its predicate device (RetroMTA-OrthoMTA II) and to the specifications of the ISO 6876:2012 standard for root canal sealing materials.

The study aimed to demonstrate substantial equivalence to the predicate device, primarily focusing on physical and chemical properties derived from the same source materials. The key difference highlighted is the SmartMTA Capsule's pre-packaged, automatic mixing system (capsule form) compared to the predicate's manual hand-mixing, which leads to a consistent powder-to-water ratio.

The study found that while some properties (Flow, Working Time, Film Thickness for the 200/140 ratio) did not strictly meet all ISO 6876:2012 criteria, these deviations were explained as non-critical due to the device's specific intended use (in the pulp chamber, not deep within the narrow root canal system) and its hydrophilic nature. The faster setting time for the 200/140 ratio was noted. Other critical properties like Solubility and Radiopacity met the ISO standard.

The manufacturer argues that the consistent mixing provided by the capsule form offers advantages in predictability and ease of use, and that historical clinical data from the predicate device (which shares the same core formulation) supports the safety and effectiveness. Biocompatibility testing on the candidate device (cytotoxicity) was also performed and confirmed safety. No new clinical studies were conducted for this 510(k) submission.

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