XP202 zirconia blanks are used for the fabrication of esthetic zirconia restorations. The blanks are available in various heights and shades based on the Vita™ Classical shade guide. After sintering, restorations display a gradient shading and inherent fluorescence. The restorations are designed using dental CAD software and the data is converted into milling paths by CAM software. The blanks can be processed in milling units suitable for pre-sintered zirconia. Milled restorations must be final sintered in a furnace suitable for zirconia per the cycle designated for XP202.

AI/ML Overview

The provided text pertains to the 510(k) premarket notification for the device XP202, a porcelain powder for clinical use (zirconia blanks for dental restorations). The document focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study with human readers or a specific acceptance criteria table for performance metrics like sensitivity/specificity.

Therefore, much of the requested information regarding clinical study design, human reader performance, and detailed statistical analysis of AI performance is not available in the provided text. The evaluation is primarily based on in vitro testing and comparison to recognized standards and predicate devices' properties.

Here's the information that can be extracted or inferred from the document:

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

The document states that in vitro testing was conducted to show that XP202 fulfills the requirements of FDA recognized standard ISO 6872: "Dentistry Ceramic materials" and compares its performance (flexural strength, chemical solubility, linear thermal expansion) to predicate devices. It concludes that "The results of XP202 are similar to Katana STML. The difference between XP202 and Lava Plus are their flexural strength and is addressed by limiting the indications to three unit bridges according ISO 6872."

Since a specific table of acceptance criteria with numerical values is not explicitly presented in the document, here's a conceptual representation based on the text:

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Standards Compliance	Fulfills requirements of ISO 6872: Dentistry Ceramic materials	Fulfilled
Flexural Strength	Similar to predicate device Katana STML; Meets requirements for indicated uses per ISO 6872	Similar to Katana STML; Differences from Lava Plus addressed by limiting indications to 3-unit bridges per ISO 6872
Chemical Solubility	Similar to predicate device Katana STML	Similar to Katana STML
Linear Thermal Expansion	Similar to predicate device Katana STML	Similar to Katana STML
Biocompatibility	Meets recommendations from FDA guidance and international standards (ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 7405)	Assessed by board-certified toxicologist; concluded safe for intended use

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for the in vitro tests. The document mentions "in vitro testing", but not the number of samples or items tested.
Data Provenance: The tests are "in vitro testing", meaning conducted in a laboratory setting. The origin of the raw materials (zirconia blanks) would be from 3M Deutschland GmbH, Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the 'ground truth' for this device is established through in vitro measurements against recognized material standards (ISO 6872), not through expert interpretation of clinical images or data with human-in-the-loop.
For biocompatibility, a "board-certified toxicologist" assessed the product, implicitly establishing "ground truth" for safety from a toxicological perspective.

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

Not applicable, as this refers to adjudication of discrepancies in expert readings, which is not part of the described in vitro material testing.

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

No, an MRMC comparative effectiveness study was not done. This device is a material (porcelain powder/zirconia blank) used for dental restorations, not an AI-powered diagnostic or assistive tool for human readers.

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

No, this is not relevant. The device is a material, not an algorithm. Its performance is evaluated through material properties in a laboratory setting, not through an algorithm's standalone performance.

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

For the performance testing, the ground truth is established by physical and chemical measurements of material properties (flexural strength, chemical solubility, linear thermal expansion) as defined by the ISO 6872 standard for dentistry ceramic materials.
For biocompatibility, the ground truth is established by compliance with ISO 10993 series standards and FDA guidance on biological evaluation of medical devices, assessed by a board-certified toxicologist.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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

3M Deutchland GmbH Ruediger Franke Regulatory Affairs Specialist EPE Platz Seefeld, Bavaria 82229 GERMANY

Re: K161922

Trade/Device Name: XP202 Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: August 26, 2016 Received: August 29, 2016

Dear Mr. Ruediger Franke:

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.

September 1, 2016

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name XP202

Indications for Use (Describe)

· Single crowns

· Bridges with a maximum of one pontic between two erowns

· Inlays, onlays, and veneers

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect. of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/14)

Page 1 of 1

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Carl-Schurz-Straße 1 41453 Neuss Germany

☎+49 (0)8152 700-0 됨 +49 (0)8152 700-1366 Internet: www.3MESPE.de E-Mail: info3MESPE@3M.com WEEE-Reg.-Nr. DE 36963167 VAT-ID: DE 120679179

510(k) Summary K161922

Submitter:	3M Deutschland GmbH
	ESPE Platz
	82229 Seefeld
	Germany
	Establishment Registration Number: 9611385

Contact Person	Ruediger Franke
	Regulatory Affairs Specialist
	Phone: +49-8152-700 1802
	Fax: +49-8152-700 1869
	e-mail: ruediger.franke@3M.com
Date:	August 23, 2016

Trade Name: ......................................................................................................................... XP202

Common Name: ................................................................................................................................................................

Classification Name:..................................... Porcelain powder for clinical use ..............................................................................................................................................................................

Device Class: ................................................................................................................................................................

Primary Predicate Device ........ Katana STML (K143439)

Reference Predicate Devices ... Lava Plus - Mill Blanks and Dyeing Liquids (K011394) ..............................................................................................................................................................................

Description of Device

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Applicable Standards for Product Tests

ISO 6872: Dentistry Ceramic materials .

Indications for Use for XP202

. Single crowns
. Bridges with a maximum of one pontic between two crowns
Inlays, onlays, and veneers .

Comparison

Chemical composition, performance, fundamental technology, and intended use of XP202 have been compared to the predicate devices.

The tables below summarize the indications and technology of XP202 and predicate devices:

XP202	Katana STML(K143439)	Lava PlusBlanks andDyeing Liquids(K011394)	Lava PlusEffect Shades(K120011)
• Single crowns• Bridges with amaximum of onepontic between twocrowns• Inlays, onlays, andveneers	KATANA Zirconia isused for thefabrication of the all-ceramic restorations(frameworks, FCZcrowns, FCZ bridges,Inlays, onlays andveneers)	The LAVA™ system isintended for CAD/CAMfabrication of all-ceramicdental restorations.The system is used forthe manufacturing ofinlays, onlays, veneers,crowns and bridges.	Lava Plus EffectShades are suitedfor more intensivecoloring of Lava Pluszirconia frameworksand Lava Plus all-zirconia restorationsafter basic dyeingusing lava PlusDyeing Liquids

Table Comparison of indications

Technology	XP202	Katana STML(K143439)	Lava Plus(K011394)(K120011)
Zirconia Mill Blanks	×	×	×
Shading	Preshaded Blanks	Preshaded Blanks	Unshaded Blanks(K011394) with dyeingliquids (K011394) andeffect shades(K120011) as shadingsolutions

Table Comparison of technology

XP202, Kanata STML and Lava Plus are zirconia mill blanks with ZrO2 as the mean component. 3M Deutschland GmbH provided information to FDA about the composition of XP202 and compared this with chemical analysis of the predicate devices.

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In vitro testing was conducted to show that XP202 fulfils the requirements of FDA recognized standard ISO 6872. Additionally, the performance of XP202 was compared to the predicate devices Katana STML and Lava Plus regarding flexural strength, chemical solubility and linear thermal expansion. The results of XP202 are similar to Katana STML. The difference between XP202 and Lava Plus are their flexural strength and is addressed by limiting the indications to three unit bridges according ISO 6872. In summary, 3M Deutschland GmbH concludes that XP202 is substantially equivalent to the predicate devices regarding performance and physical properties.

Biocompatibility

The biocompatibility assessment for this product was conducted in accordance with the following quidance:

Testing guidelines outlined in the FDA General Program Memorandum G95. 2) ISO 10993-1 :2009(E) Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process; in addition, relevant detailed guidance in ISO Standards 10993-3:2014 (Tests for genotoxicity, carcinogenicity and reproductive toxicity), 10993-5:2009 (Tests for in vitro cytotoxicity), 10993-10:2010 (Tests for irritation and skin sensitization); and 10993-11:2006 (Tests for systemic toxicity) was considered;
ISO 7405:2008/ Amd 1: 2013 Dentistry-- Evaluation of Biocompatibility of Medical Devices in Dentistry;

The biocompatibility of XP202 has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that XP202 is safe for its intended.

Conclusion .

Comparisons of the indications for use/intended use, composition, technology, and physical properties showed that XP202 does not raise any new questions about safety and effectiveness and is substantially equivalent to the predicate devices.

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.