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.

AI/ML Overview

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:

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.
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).
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No such human test set described.
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.
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.
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.
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.
How the ground truth for the training set was established:
- Not applicable.

Summary

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JUL 31 1998

K981620

510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343

P. J. Lehn Telefax (717) 849-4343

CONTACT: P. Jeffery Lehn

DATE PREPARED: MAY 8 ,1998

TRADE OR PROPRIETARY NAME: MTA MATERIAL

Root Filling Material COMMON OR USUAL NAME:

872.3820 Root canal filling resin material CLASSIFICATION NAME: K964174 PREDICATE DEVICE: Mineral Trioxide Aggregate K980332 MTA Material

DEVICE DESCRIPTION: MTA MATERIAL is identical to K964174 and K980332. 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.

INTENDED USE: MTA MATERIAL is indicated for use as a root end filling material.

TECHNOLOGICAL CHARACTERISTICS: MTA MATERIAL is identical to DENTSPLY'S K964174 and K980332. This submission is for an additional intended use.

The fact that the formula is identical to K964174 and K980332 leads to the conclusion that biocompatibility studies with the formulation are not necessary

Therefore, we believe 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.

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Substantial Equivalence Comparison:

ID of Predicate Device:

K964174 and K980332 are the predicate devices for this submission. MTA MATERIAL is identical to the predicates. This submission is for a new intended use only.

Statement of Similarities and/or Differences:

MTA MATERIAL is identical to K964174 and K980332. This submission is for a new intended use only.

This submission addresses the new intended use: Root end filling material. ●
K980332 addresses the uses: 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.
K964174 addresses the use: Intended to be applied to a tooth to protect the pulp. ●

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure in black, with its wings forming a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird. The text is in all capital letters and is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 | 1998

Mr. P. Jeffrey Lehn ·Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re : K981620 MTA Material II Trade Name: Requlatory Class: İI Product Code: KIF Dated: May 5, 1998 May 6, 1998 Received:

Dear Mr. Lehn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Lehn

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

: 中

Sincerely yours,

S. Dutrow for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(K) Number:

Device Name:

MTA MATERIAL II

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Skinner

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices 510(k) Number J K98 160

000007

Regulation Number and Section

§ 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.