Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.

Device Description

Heisenberg Dyeing Liquid is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Heisenberg Dyeing Liquid is intended to be used for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth. Heisenberg Dyeing Liquids will be available in various shades which are corresponding to every tooth color.

AI/ML Overview

This is a difficult request since the provided text describes a dental dyeing liquid and not a medical device that would typically involve acceptance criteria and a study with performance metrics in the way you've outlined. The submission is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance.

However, based on the information provided, I can construct an answer by reinterpreting "acceptance criteria" and "device performance" in the context of a 510(k) for a dyeing liquid. The "study" here refers to the testing done to demonstrate substantial equivalence, which primarily involves comparing the new device to the predicate device.

Here's how I'll address each of your points, making assumptions where necessary to fit the framework you've provided:

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

For a dyeing liquid, the "performance" isn't in terms of diagnostic accuracy, but rather in meeting the functional and safety requirements to be equivalent to its predicate. The acceptance criteria would be that its properties are comparable or equivalent to the predicate device.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (Summary from text)
Chemical Composition: Equivalent or acceptable differences	Differs primarily in coloring ions and secondary chemistry; deemed acceptable.
Indications for Use:	"Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth." (Identical to predicate's type of use, though specific zirconia framework name has changed from Lava Mill Blanks to Heisenberg zirconia).
Physical and Mechanical Properties: Equivalent (e.g., chemical solubility, strength, remission)	The comparison for performance data shows that Heisenberg Dyeing Liquids are substantially equivalent to the predicate device.
Biocompatibility: Safe for intended use	Biocompatibility testing was carried out, finding the device safe.
Overall Safety and Effectiveness:	Concluded to be as safe and effective as the predicate device (Lava Frame Shade).

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

The text does not specify sample sizes or detailed data provenance for the tests conducted to compare the Heisenberg Dyeing Liquids to the Lava Frame Shade. It broadly states "The comparison for chemistry, indications for use, and performance data shows that Heisenberg Dyeing Liquids are substantially equivalent to the predicate device." It also mentions "Biocompatibility testing was carried out."

Sample Size: Not specified.
Data Provenance: Not specified, but the applicant company is 3M ESPE AG from Germany. The testing would have been conducted by or for them. The nature of the tests (chemical, physical, mechanical, biocompatibility) usually implies laboratory-based, prospective testing for the specific purpose of the 510(k).

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)

This type of information is not relevant to a 510(k) for a dyeing liquid, as "ground truth" in the clinical imaging sense is not established. The evaluation relies on laboratory tests and comparative analysis by chemists and materials scientists to demonstrate equivalence to a known predicate device. No details are provided about the experts involved in conducting or evaluating these specific tests.

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

Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical images or diagnostic outcomes. This is not applicable to the type of comparative testing done for a dental dyeing liquid. The "adjudication" in this context would be the internal scientific review and regulatory assessment of the test results by the manufacturer and subsequently by the FDA.

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

An MRMC study is completely irrelevant for this device. This is a dyeing liquid, not a diagnostic AI system. There are no "human readers" interpreting images or clinical data, and no AI involved.

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

This concept is not applicable. The device is a material (dyeing liquid), not an algorithm or software. Its performance is intrinsic to its chemical and physical properties when applied as intended.

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

For this device, the "ground truth" for the comparison is the established properties and safety profile of the predicate device, Lava Frame Shade (K011394). The new device is compared against the known characteristics and performance of this predicate using laboratory-based chemical, physical, mechanical, and biocompatibility tests.

8. The sample size for the training set

This concept is not applicable. There is no "training set" for a dyeing liquid. Data is collected through laboratory testing of the material itself.

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

Not applicable, as there is no training set for this type of device. The relevant "ground truth" is the performance of the legally marketed predicate device, established through its own prior regulatory clearance (K011394), which would have involved similar types of laboratory evaluations at the time.

Summary

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KIIIa57

MAY 1 3 2011

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter

Company:	3M ESPE AG
Street:	ESPE Platz
ZIP-Code, City:	D-82229 Seefeld
Federal State:	Bavaria
Country:	Germany
Establishment Registration Number	9611385
Official Correspondent:	Dr. Desi W. Soegiarto,Regulatory Affairs Specialist
Phone:	+49-8152-700 1169
Fax:	+49-8152-700 1869
E-mail:	desi.soegiarto@mmm.com
Date:	April 15, 2011

Name of Device

Proprietary Name:	Heisenberg Dyeing Liquids
Classification Name:	Porcelain powder for clinical use
Common Name:	Dyeing liquid

Predicate Device

Lava Frame Shade by 3M ESPE, Germany..........................................................................................................................................

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Description for the Premarket Notification

Heisenberg Dyeing Liquid is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660).

Heisenberg Dyeing Liquid is intended to be used for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.

Heisenberg Dyeing Liquids will be available in various shades which are corresponding to every tooth color.

Predicate device to which Heisenberg Dyeing Liquids have been compared is Lava Frame Shade by 3M ESPE (K011394). Lava Frame Shade is suited to be used for the shading of zirconia frameworks and all-zirconia, monolithic restorations (made from Lava Mill Blanks by 3M ESPE, K011394) for anterior and posterior teeth. The difference to the predicate device is primary in the change of coloring ions and secondary in the change of the general chemistry.

In this 510(k) premarket notification Heisenberg Dyeing Liquids have been compared to its predicate device with regard to chemical composition, indications for use, and physical and mechanical properties (e.g. chemical solubility, strength, remission). The comparison for chemistry, indications for use, and performance data shows that Heisenberg Dyeing Liquids are substantially equivalent to the predicate device: Lava Frame Shade by 3M ESPE, Germany (K011394).

Biocompatibility testing was carried out.

In summary, it can be concluded that Heisenberg Dyeing Liquids are as safe and effective as the predicate device Lava Frame Shade by 3M ESPE, Germany (K011394).

Indications for Use:

Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with three lines representing its wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 3 2011

3M Espe AG C/O Mr. Norbert Stuiber Responsible Third Party Official TÜV SÜD America, Incorporated 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

Re: K111257

Trade/Device Name: Heisenberg Dyeing Liquids Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: April 29, 2011 Received: May 4, 2011

Dear Mr. Stuiber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Stuiber

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K111257
Device Name:	Heisenberg Dyeing Liquids
Indications For Use:	Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restora- tions for anterior and posterior teeth.

X Prescription Use (Part:21 CFR 801 Subpart Dị

: ·

AND/OR

Over-The-Counter Use _ (21 CFR 501 Subpart Cị

iplease do not write below this line-continue on another Page if NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Turner

Division Sign-Off) nvision of Anesthesiology, General Hospital tiection Control, Dental Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

›10(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.