(115 days)
Indicated clinical applications include use as repair of pulpal exposures.
Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure.
Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.
This document provides a summary for a 510(k) submission for a medical device, Mineral Trioxide Aggregate (MTA), a dental cement. It does NOT contain the details of an acceptance criteria study as typically understood in the context of an AI/ML or diagnostic device.
The information provided describes the device, its intended use, and states that it is substantially equivalent to other devices on the market. It highlights some performance characteristics like setting time and compressive strength, but these are descriptive properties of the material, not acceptance criteria from a formal study proving clinical effectiveness or diagnostic accuracy.
Therefore, most of the requested information cannot be extracted from this text. Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied/Directly Stated) | Reported Device Performance |
|---|---|
| Set in presence of moisture | Consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure. |
| Biocompatible | Mineral Trioxide Aggregate is biocompatible. |
| Better adaptation to dentinal walls | Exhibits significantly better adaptation to dentinal walls than other materials. |
| High degree of sealability | Possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. |
| Setting time | Setting time after hydration and application is approximately three hours. |
| Compressive strength at 21 days | In tests, its compressive strength at 21 days is about 70 MPa. |
| Intended Use: Repair of pulpal exposures | Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. |
| Substantial Equivalence | This product has the same intended use as similar products currently cleared for marketing. The technological characteristics are substantially equivalent to those of similar products. |
Missing Information/Not Applicable:
The document does not define specific, quantifiable acceptance criteria for clinical outcomes (e.g., success rate of pulpal exposure repair) or diagnostic performance (e.g., sensitivity, specificity, AUC), nor does it present data from a formal clinical study designed to meet such criteria. The "performance" values described are material properties from laboratory tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This document is a summary for a 510(k) submission, not a detailed study report. The "tests" mentioned (e.g., for compressive strength) are likely laboratory material tests, not clinical trials with a test set of patients.
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. There is no "test set" of patient data in the sense of a diagnostic or AI study mentioned. Ground truth as typically defined for such studies is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 a dental material, not an AI/ML-driven diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for a dental cement would be its measured physical and biological properties in laboratory and potentially animal studies, and then clinical outcomes in human trials. This document reports some physical properties ("compressive strength") from "tests" (implying lab measurements), but doesn't detail clinical ground truth or how it was established.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, this document fulfills the requirements of a 510(k) summary for a traditional medical device by describing its properties and claiming substantial equivalence. It does not provide the kind of detailed study information (especially concerning acceptance criteria for diagnostic performance, sample sizes, expert ground truth, or AI/ML study design) that would be expected for a submission involving software or AI.
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Shaping The Future of Endodontics
J. Safe Medical Devices Act of 1990 Summary of Safety and Effectiveness:
FEB 1 0 1997
Tulsa Dental Products Submitted by: Russ Vanderslice 5001 East 68th Street, Suite 500 Tulsa, OK 74136
A. Classification Names and Numbers: Dental Cement (other than zinc oxide-eugenol), 76EMA, CFR 872.3275.
B. Common/Usual Names: Dental Cement
C. Proprietary Name: Mineral Trioxide Aggregate (MTA)
D. Establishment Registration Number: 1643003
E. Classification: This device can be classified as a Class II device: D Coment (other than zinc oxide-eugenol), 76 EMA, CFR
F. Performance Standard: Performance standards have not been established.
G. Description of the Device: Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure.
Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.
H. Determination of Substantial Equivalence Process: This product has the same intended use as similar products currently cleared for marketing by the 510(k) process for the purpose of repairing pulpal exposures. The technological characteristics for this product are substantially equivalent as those of similar products, used for identical purposes, currently on the market. We believe that sufficiently precise specifications for this material from which this product is constructed have been supplied.
Corporate Headquarters 5001 East 68th Street, Suite 500 Tulsa, OK 74136-3332 1-800-379-3432 (918) 493-6598 Fax: (918) 493-6599
Manufacturing 3111 Hanover Road Johnson City, TN 37604 1-800-669-0822 (423) 282-1453 Fax: (423) 282-1995
Distribution 3213 Hanover Road Johnson City, TN 37604 1-800-474-0298 (423) 282-8114 Fax: (423) 282-8661
4
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.