Search Results

Ask a specific question about this device

MTA MATERIAL is indicated for use as a root end filling material.
MTA MATERIAL II is indicated for use as a root end filling material.

MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.

The provided text is related to a 510(k) premarket notification for a dental material called "MTA MATERIAL." The notification states that MTA MATERIAL is identical to previously cleared predicate devices (K964174 and K980332) but is seeking clearance for a new intended use: as a root end filling material.

The crucial information needed to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided 510(k) summary and FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a predicate device based on identical composition and previous biocompatibility studies, rather than providing detailed clinical study results for the new intended use.

Here's why the information is missing and an explanation of what is available:

• Identical Device, New Intended Use: The core of this submission is that "MTA MATERIAL is identical to K964174 and K980332." Because the composition is the same, the manufacturer argues that prior biocompatibility and performance data for the material itself from the predicate devices supports the safety and effectiveness for the new intended use.
• No New Clinical Study for Substantial Equivalence: For a 510(k) submission, especially when a device is identical to a predicate for a new, but related, intended use, a full-blown clinical trial with detailed acceptance criteria might not have been required by the FDA. The submission states, "The fact that the formula is identical to K964174 and K980332 leads to the conclusion that biocompatibility studies with the formulation are not necessary." It also mentions "in-vitro and animal study performance data provided, and the results of previous testing in K964174." This implies reliance on non-clinical data and existing data for the predicate, not a new human clinical study specifically designed for the "root end filling" indication with defined acceptance criteria.

Therefore, I cannot provide the requested table or study details because the provided documents do not contain them.

Here is what can be extracted and inferred based on the documents:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated for the "root end filling" intended use in this document. The implicit acceptance criteria would have been "substantial equivalence" to the predicate devices for safety and effectiveness, based on identical material composition and existing data.
   • Reported Device Performance: The document only states that "the prior use of the formula in K964174 and K980332, the in-vitro and animal study performance data provided, and the results of previous testing in K964174 support the safety and effectiveness of MTA MATERIAL for the new intended use." No specific performance metrics (e.g., success rates, leakage rates, healing times) are reported here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified. The reference is to "in-vitro and animal study performance data" and "results of previous testing in K964174." These would be non-human studies.
   • Data Provenance: Not specified, but likely from laboratory (in-vitro) and animal studies. Type: Retrospective (referring to existing data from K964174 and K980332).

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. No human clinical "test set" with ground truth established by experts is described in this submission.

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

   • Not applicable. No such human test set described.

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 a material for a dental procedure, not an AI diagnostic device.

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

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

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

   • For the "in-vitro and animal study performance data," the ground truth would typically be measured physical, chemical, or biological parameters relevant to material performance (e.g., pH, setting time, radiopacity, cell viability in vitro, tissue response in animal models), rather than clinical outcomes on human patients.

8. The sample size for the training set:

   • Not applicable. No "training set" in the machine learning sense is described. The "training" here refers to the extensive prior testing and use of the identical material under previous clearances.

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

   • Not applicable.

Ask a specific question about this device

MTA MATERIAL is indicated for the repair of root canals as an apical plug during Apexification, and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.

MTA MATERIAL is identical to K964174, Mineral Trioxide Aggregate (found substantially equivalent February 10, 1997). This submission is for a new intended use. MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.

This 510(k) submission (K980332) for "MTA MATERIAL" describes a device that is identical in composition to a previously cleared device (K964174, Mineral Trioxide Aggregate) but is seeking clearance for new intended uses. Therefore, the acceptance criteria and performance data presented relate to the suitability of the existing material for these new indications.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a new intended use of an identical material, the acceptance criteria are implicitly tied to demonstrating the effectiveness of the material for the specified new indications through various in-vitro and animal studies. There aren't explicit quantifiable "acceptance criteria" presented in the manner of a typical performance study for a novel device, but rather a demonstration of biological and functional performance in relevant models.

Ask a specific question about this device