3M TR SYSTEM by 3M COMPANY | FDA 510(k) Summary

3M™ TR System is a ceramic material. It is intended to be used by dental laboratories and dentists (with chair side dental milling units) to create specific restorations.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the 3M™ TR System based on the provided text:

Important Note: The provided 510(k) summary focuses on demonstrating substantial equivalence for a dental material (3M™ TR System) to predicate devices. It primarily relies on bench testing of material properties rather than clinical studies with human subjects to evaluate diagnostic or prognostic performance. Therefore, many of the requested categories related to human-in-the-loop performance, ground truth establishment for diagnostic accuracy, and expert consensus are not applicable or not detailed in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Properties: Comparing key physical and mechanical properties to predicate devices.	Similar Technological Characteristics: Validated by comparing results of published laboratory data and 3M generated bench data.
Compressive Strength: Performance compared to predicate devices.	Test results were obtained and compared. (Specific values not provided in the summary, but implied to be comparable or better than predicates).
Fracture Toughness: Performance compared to predicate devices.	Test results were obtained and compared. (Specific values not provided in the summary, but implied to be comparable or better than predicates).
Flexural Strength: Performance compared to predicate devices.	Test results were obtained and compared. (Specific values not provided in the summary, but implied to be comparable or better than predicates).
Safety and Effectiveness: Demonstrating the material is safe and effective for its intended use.	Based on conclusions from safety information, past history of use, bench testing results, and published literature, the 3M™ TR System is stated to be safe, effective, and performs as well or better than predicate devices.
Intended Use Equivalence: Ability to be used for fabricating copings and frameworks for inlay, onlay, veneer, crown, and anterior bridge restorations.	The device is indicated for these uses, aligning with the predicates.

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

Sample Size: Not explicitly stated. The submission refers to "bench data" and "published laboratory data." For material property testing, it would involve multiple samples of the material for each test (e.g., several specimens for compressive strength, fracture toughness, and flexural strength).
Data Provenance: The data provenance is primarily from "3M generated bench data" and "published laboratory data." This indicates laboratory settings. The country of origin is implicitly the US, where 3M is based, and where the testing would have occurred. It is retrospective in the sense that the data was collected prior to submission.

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

Not Applicable (N/A): For a dental material's physical property testing, the 'ground truth' is established by standardized laboratory testing methods and measurements, not by human expert interpretation or consensus. There are no "experts" establishing a diagnostic ground truth in this context.

4. Adjudication Method for the Test Set

Not Applicable (N/A): As per the above, this is not a study requiring human adjudication for diagnostic outcomes. The "adjudication" in material science typically refers to the adherence to established ASTM or ISO standards for testing and interpretation of results by qualified laboratory personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, N/A: This submission is for a dental material, not a diagnostic or AI-powered imaging device that would typically undergo MRMC studies comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, N/A: This is a physical material, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

Laboratory Measurements and Standards: The "ground truth" for this device's performance is derived from quantitative measurements of its physical and mechanical properties (compressive strength, fracture toughness, flexural strength) obtained through standardized laboratory testing protocols (e.g., ISO, ASTM standards relevant to dental materials). This is compared against similar measurements for predicate devices.

8. The Sample Size for the Training Set

Not Applicable (N/A): This is a material, not a machine learning algorithm. There is no "training set" in the context of AI. The device's formulation and manufacturing processes are developed and refined through R&D, but this isn't a "training set" in the computational sense.

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

Not Applicable (N/A): As there is no training set for an AI algorithm, this question is not relevant. The material properties are inherent to its composition and structure, and these are validated through scientific experimentation and testing, not by establishing a ground truth for a training dataset.

Summary

{0}------------------------------------------------

K 992489

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name:	Lael J. PickettRegulatory Affairs Specialist
Address:	3M Dental Products Laboratory3M Center, Building 260-2B-12St. Paul, MN 55144-1000
Telephone:	612-733-3594
Fax:	612-736-0990
Trade Name:	3M™ TR System
Common Names:	Porcelain mill block material, Alumina core material
Classification Name:	21 CFR § 872.6660 Porcelain powder for clinical use, Class II

Vitabloc Mark II and In-Ceram Alumina both made by Vident Predicate Devices:

3M™ TR System is a ceramic material. It is intended to be used by dental laboratories and dentists (with chair side dental milling units) to create specific restorations.

The 3M™ TR System is indicated for copings and frameworks for inlay, onlay, veneer, crown and anterior bridge restorations. 3M™ TR System is not indicated as an implant material. The 3M™ TR System is not recommended for bruxers or clinchers.

3M™ TR System and predicate devices have similar technological characteristics. This has been validated by the comparing results of published laboratory data, along with 3M generated bench data. These tests include compressive strength, fracture toughness and flexural strength.

Based on the conclusions drawn from the safety information available on this material, past history with it's use, the results of the bench testing and published literature, the 3M™ TR System is safe, effective and performs as well or better than the predicate devices mentioned above.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or abstract shape, consisting of three curved lines that resemble wings or feathers.

Public Health Service

'JAN 1 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lael J. Pickett Regulatory Affairs Specialist 3M Center St. Paul, MN 55144-1000

Re: K992489 3MTM TR System Trade Name: Requlatory Class: II Product Code: EIH Dated: July 16, 1999 Received: July 26, 1999

Dear Mr. Pickett:

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 registration, listing of devices, good 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) requlation (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

{2}------------------------------------------------

Page 2 - Mr. Pickett

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.

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 requlation (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.fdaggov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{3}------------------------------------------------

510(k) Number (if known):

Device Name: 3M™ TR System System

Indications For Use: This device is indicated for:

Fabricating copings and frameworks for inlays, onlays, veneers, crowns and anterior bridge . restorations

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Susan Runne

(Division Sign-Off) Division of Dental, Infection Contr and General Hospi 510(k) Number

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.