The NobelProcera Ti Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

Device Description

Nobel Biocare's NobelProcera Ti Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental implant abutment, not an AI device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from the given text. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (fatigue testing and analysis of platforms).

Here's an attempt to answer the questions based on the type of information that would be relevant if it were an AI device, but highlighting that this specific document does not contain that information:

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

Acceptance Criteria	Reported Device Performance
Not Applicable (N/A): This is a mechanical device, not an AI or diagnostic device with performance metrics like sensitivity, specificity, or accuracy.	N/A: The document states "The testing indicates That the device is safe and effective for its intended use and performs as well or better than the predicate devices." This is a qualitative statement of equivalence, not a quantitative performance result against specific criteria.

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

Sample Size for Test Set: Not applicable. The testing was non-clinical and involved "analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples." No patient data or test set in the context of AI or diagnostic performance was used.
Data Provenance: Not applicable. No patient data or images were used.

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)

Not applicable. As no patient data or diagnostic interpretations were involved, there was no need for experts to establish ground truth in this context. The "truth" in this case is the mechanical integrity and performance as measured through engineering tests.

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

Not applicable. There was no test set requiring human adjudication as this was non-clinical mechanical 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. This study did not involve human readers or AI assistance.

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

No. This device is a physical dental abutment, not an algorithm.

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

The "ground truth" for this device's performance was established through engineering standards and physical testing. Specifically, fatigue testing was performed "in accordance with the FDA quidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance document would define the acceptable mechanical properties and performance thresholds.

8. The sample size for the training set

Not applicable. This device is a manufactured medical component, not an AI model that requires a training set.

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

Not applicable. No training set was used.

Summary

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510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Herbert CraneDirector, Global Regulatory Affairs
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887	AUG 31 2010
Telephone:	(714) 282-5074
Facsimile:	(714) 998-9348
Date of Submission:	June 17, 2010
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Trade or Proprietaryor Model Name:	NobelProcera Ti Abutment Thommen Platforms
Legally Marketed Devices:	Nobel Biocare - NobelProcera Ti Abutment (K091756)Thommen Medical AG - SPI Easy 4.0 Abutment (K071457)Thommen Medical AG - SPI Dental Implant Abutments (K031747)

Device Description:

Nobel Biocare's NobelProcera Ti Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

Indications for Use:

Summary of testing to demonstrate safety and effectiveness

Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples in accordance with the FDA quidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates That the device is safe and effective for its intended use and performs as well or better than the predicate devices.

Nobel Biocare Special 510(k) Notification NobelProcera Ti Abutments Thommen Platforms June 2010

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Substantial Equivalence Comparison to Predicate Devices

など

ATTRIBUTE	CANDIDATE	PREDICATE	PREDICATE	PREDICATE
Design/construction	Nobel Procera TiAbutmentThommen Platforms	NobelProcera Ti Abutment(K091756)	Thommen Medical AGSPI Easy 4.0 Abutment(K071453)	Thommen Medical AGSPI Dental Implant Abutments(K031747)
AnatomicalSite	Patient specific / machinedOral Cavity	Patient specific / machinedOral Cavity	Patient specific / machinedOral Cavity	Patient specific / machinedOral Cavity
Platformcompatibility	ThommenSPI implant systems platform3.5, 4.0, 4.5, 5.0, 6.0	Nobel BiocareBrånemark NP, RP, WPReplace NP, RP, WP, 6.0Active NP, RP	ThommenSPI implant systems platform4.0	ThommenSPI implant systems platform3.5, 4.5, 5.0, 6.0
		Astra TechYellow, Aqua, Lilac
		StraumannOctagon 3.5, 4.8, 6.5Bone Level 3.3, 4.1/4.8
		BIOMET 3iInternal 3.4, 3.75/4.0, 5.0, 6.0External 3.4, 4.1, 5.0, 6.0
DeviceMaterial	CP TitaniumTitanium/vanadium alloy	CP TitaniumTitanium/vanadium alloy	CP Titanium	CP Titanium
Indications forUse	The Nobel Procera TiAbutments arepremanufactured prostheticcomponents directlyconnected to endosseousdental implants and areintended for use as an aid inprosthetic rehabilitation.	The Nobel Procera Ti Abutmentsare premanufactured prostheticcomponents directly connected toendosseous dental implants andare intended for use as an aid inprosthetic rehabilitation.	The Thommen SPI Easy 4.0Abutment is intended to be usedin conjunction with SPI Systemdental implants in the maxillaryand/or mandibular arch toprovide support for crowns,bridges or overdentures.	The Thommen SPI Dental ImplantAbutments are intended to beused in conjunction with SPISystem dental implants in themaxillary and/or mandibular archto provide support for crowns,bridges or overdentures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which features a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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

Nobel Biocare AB C/O Mr. Herbert Crane Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

AUG 31 2010

Re: K101714

Trade/Device Name: NobelProcera Ti Abutment Thommen Platforms Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 2, 2010 Received: August 3, 2010

Dear Mr. Crane:

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. Crane

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.

Wh 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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510(k) Number (if known): Klol 714

Device Name: NobelProcera Ti Abutment Thommen Platforms

Indications For Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rei Mulley for HSR

(Division Sign-Off) Division of Anesthesiology, General Ho Infection Control, Dental Devices

000020 510(k) Number: K | 0 \ 7 | 4

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)