Procera® AllCeram Bridge Material is composed of Procera® AllCeram Connection Material (a premixed suspension of aluminium oxide I rooff - Tiroerant of the particles, binder of the particles and deionised water) and Procera® AllCeram Fusing Material (a suspension of glass material and water) Procera® AllCeram Bridge Material is used to fuse together the sections of the core material in densely sintered aluminium oxide of a dental bridge.

Device Description

Procera® All Ceram Bridge Material is composed of Procera® AllCeram Connection Material (a premixed suspension of aluminium oxide particles, dispersant of the particles, binder for the particles and de-ionized water) and Procera® AllCeram Fusing Material (a suspension of glass material and water). Procera 8All Ceram Bridge Material is used to fuse together sections of core material in densely sintered aluminium oxide of a dental all ceramic bridge.

AI/ML Overview

The provided text describes a 510(k) summary for the "Procera® AllCeram Bridge Material" and its comparison to a predicate device. The core of the submission revolves around demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparing technological characteristics and performance, particularly concerning fracture resistance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are generally not explicitly stated as numerical targets like in a clinical trial. Instead, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device is as safe and effective as the predicate, either through identical technological characteristics or, if different, by demonstrating that the new characteristics do not raise new questions of safety or effectiveness and are at least as effective as the predicate.

In this specific case, the performance metric highlighted is fracture resistance.

Acceptance Criteria (Implied)	Reported Device Performance (Procera® AllCeram Bridge Material)
Substantial Equivalence to Predicate Device (Procera® AllCeram Fusing Material)	Claimed substantially equivalent (K020269)
Fracture Resistance	Between 24% to 47% increased strength compared to predicate
Intended Use	Same as predicate
Fusing Temperature	Same as predicate
Chemical Composition (glass phase)	Same as predicate
Chemical Composition (overall)	Contains aluminum oxide particles, predicate does not
Sintered Structure	Reinforced with aluminum oxide particles, predicate is not

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

The provided text does not explicitly state the sample size used for the fracture resistance testing or the data provenance (e.g., country of origin, retrospective/prospective). It only states the comparative performance.

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

The text does not mention using experts to establish ground truth for a test set. The evaluation seems to be based on direct material property testing (fracture resistance) rather than expert interpretation of data like images or clinical outcomes.

4. Adjudication Method for the Test Set

Since the evaluation appears to be based on direct material property testing rather than subjective assessments, an adjudication method like 2+1 or 3+1 for establishing ground truth is not applicable and not mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

An MRMC study is typically used for diagnostic imaging devices where human readers interpret medical images. The Procera® AllCeram Bridge Material is a dental material/device, and the provided information focuses on its material properties. Therefore, an MRMC study was not done, and there is no mention of human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device's performance in this context is based on material property testing, specifically fracture resistance (strength). This is a direct measurement of the device's physical capabilities, not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic or therapeutic devices. The ground truth for chemical and structural composition would be derived from analytical chemistry and microscopy, respectively.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant to machine learning or AI models. Since this is a dental material and not an AI system, there is no training set in the context of the provided information.

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

As there is no training set, this question is not applicable.

Summary

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K020269

MAR 2 7 2002

VII. 510(k) SUMMARY

Manufacturer Information:

Submitters Name:	Procera Sandvik AB
Address:	Lerkrogsvägen 19126 80 StockholmSweden
Contacts name:	Agneta Odén, MSc, Ph.D., DDSDirector Quality Assurance and Regulatory Affairs
Telephone Number	+46 8 726 66 19
Data Prepared:	January 2001

Device Names:

Comman Name:	Glass reinforced with Aluminium Oxide Particles
Trade Name:	Procera® AllCeram Bridge Material

Predicate Device:

Substantial equivalence is claimed to Nobel Biocare AB' Procera® AllCeram Fusing Material (K983453).

Device Description:

Intended Use:

Procera Sandvik's Procera 9 All Ceram Bridge Material is intended to be used to fuse together the sections of an aluminium oxide framework for a dental bridge.

Comparison to Predicate:

The following table (Table 7.1 and Table 7.2) provides a comparison of the technological characteristic of the candiate Procera Sandvik's Procera "All Ceram Bridge Material to the predicate Nobel Biocare's Procera "All Ceram Fusing Material

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510(k) Summary (continued)

Table 7.1. Similarities to the predicate

Table 7.1. Similarities to the predicate
Procera®All Ceram BridgeMaterial	Aspect/Characteristic	Comment
	Intended use	Same as predicate
	Fusing temperature	Same as predicate
	Chemical composition ofsintered joint glassmaterial	Same as predicate

Table 7.2. Differences from the predicate

Procera ®All Ceram Bridge	Aspect/Characteristic	Comment
Material
	Sintered structure of jointmaterial	Candidate is reinforcedwith aluminium oxideparticles.
		Predicate is not
	Fracture resistance	Candidate has between 24to 47% increased strengthcompared to predicate
	Chemical composition ofsintered joint material	The glass phase has thesame chemicalcomposition as predicate.The candidate containsaluminium oxide particlesthe predicate does not.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2002

Dr. Agneta Oden Director, Quality Assurance and Regulatory Affairs Procera Sandvik AB Lerkrogsvagen 19, Vastberga 12680 Stockholm, SWEDEN

Re: K020269

Trade/Device Name: Procera® AllCeram Bridge Material Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 24, 2002 Received: January 28, 2002

Dear Dr. Oden:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Dr. Oden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be advisouration 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); an the Act I FFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricio Cincotti/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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Indications for Use Statement

K020269 not yet assigned 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Procera® AllCeram Bridge Material _______________________________________________________________________________________________________________________________

Indications For Use: Procera® AllCeram Bridge Material is composed of

Procera® AllCeram Connection Material (a premixed suspension of aluminium oxide I rooff - Tiroerant of the particles, binder of the particles and deionised water) and

Procera® AllCeram Fusing Material (a suspension of glass material and water)

Procera® AllCeram Bridge Material is used to fuse together the sections of the core material in densely sintered aluminium oxide of a dental bridge.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1

Over-the-Counter Use

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Surar Vunny

"Twisian Sign-Off) Division of Dental, Infection Control, and General Hospital Devices Kasasta E10(k) Number ________________________________________________________________________________________________________________________________________________________________

Page 2.1

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.