The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

AI/ML Overview

The provided text describes a 510(k) submission for the SFI-Bar® Abutment, a dental device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria for each test. Instead, it states that "The acceptance criteria were met" and that the "SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®." The performance characteristics evaluated are generally described.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent performance characteristics to the predicate SFI-Bar®	"Testing has shown that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®." This equivalence is established through:
(Specific torque values for mechanical stability not explicitly stated)	Torque tests: Conducted to evaluate performance characteristics. The methods used were the same as in the predicate device. The device was found to be equivalent in performance.
(Specific functional criteria not explicitly stated)	Application testing: Conducted to evaluate performance characteristics. The methods used were the same as in the predicate device. The device was found to be equivalent in performance.
(Specific functional criteria not explicitly stated)	Functional testing: Conducted to evaluate performance characteristics. The methods used were the same as in the predicate device. The device was found to be equivalent in performance. Key functional characteristics mentioned (also shared with the predicate) include: primary splinting of implants, countering forces that would dislodge the denture, distribution of shear forces, resilience compensation, common cleaning procedures for patients, and common patient handling (cleaning and insertion of denture).
(Shelf life performance equivalent to predicate)	Shelf life: "95% after 10 years" (same as predicate device).
(Manufacturing processes and materials equivalent to predicate)	Packaging, materials and processes: "Produced on process orientated CNC machines. The last step is a validated cleaning process (same processes). Packaging: Dentalblister, non-sterile." The material is "Wrought Titanium-6Aluminium-4Vanadium ELI Alloy for Surgical Implant applications" conforming to ASTM F 136 (same as predicate).
(Compatibility with specified implant systems)	Compatibility: The SFI-Bar® Abutment is designed to connect with various dental implant systems from Thommen Medical, Neoss, and Institut Straumann (specifically listed in Table 1). The development and manufacturing were done "in close cooperation with the implant companies" with Quality Agreements in place (Design Control, Change Control, Complaint Handling, and Post Market Surveillance). This implies successful compatibility testing was conducted to ensure proper fit and function with these diverse implant systems, similar to the predicate device's compatibility.
(Safety for intended use)	"The summary of technological characteristics as well as the torque test, application and functional testing indicate that the device is safe and effective for its intended use and performs as well or better than the predicate devices." This is a general conclusion based on the non-clinical testing and comparison to the predicate, demonstrating that the device does not raise new questions of safety or effectiveness. This is the overarching "acceptance criterion" for a 510(k) submission seeking substantial equivalence.

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

Sample Size: The document does not specify the exact sample sizes used for the torque tests, application testing, or functional testing. It only states that these tests were conducted.
Data Provenance: The data is non-clinical test data. The country of origin of the data is not explicitly stated, but the applicant (Cendres+Métaux SA) is located in Switzerland. The testing was conducted to support a 510(k) submission to the FDA (USA). The study is retrospective in the sense that it relies on existing testing methodologies and comparisons to a previously cleared predicate device.

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

This information is not applicable (N/A) as the study described is a non-clinical, bench testing study comparing the performance of a new device to a predicate device. There is no "ground truth" derived from expert review of cases or outcomes in a clinical context. The "ground truth" for the testing would be established by validated test methods and engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not in bench testing of a dental implant abutment.

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

This information is not applicable (N/A). The device described, the SFI-Bar® Abutment, is a physical dental implant component, not an AI or imaging diagnostic device. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.

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

This information is not applicable (N/A). As mentioned in point 5, this is a physical dental device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of non-clinical device testing is engineering specifications, validated test methods, and the performance characteristics of the legally marketed predicate device. The goal is to demonstrate that the candidate device performs "as well or better than" the predicate device under the same test conditions. There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in the clinical sense for this specific evaluation. The "worst-case test samples" were identified through analysis of platforms, indicating an engineering-based approach to defining test parameters.

8. The Sample Size for the Training Set

This information is not applicable (N/A). There is no concept of a "training set" in the context of this non-clinical bench testing for a physical dental device. Training sets are relevant for machine learning algorithms or similar data-driven models.

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

This information is not applicable (N/A), as there is no training set for this type of device submission.

Summary

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K102382

21.10.2010

DEC - 3 2010

510(k) Summary

Applicant's Name and Address

Submitter:

Contact Person:

October 21, 2010

Tanja Bongni

Phone: Fax:

Cendres+Métaux SA

Rue de Boujean 122

2501 Biel/Bienne, Switzerland

Consultant Regulatory Affairs

+41 58 360 20 00

+41 58 360 20 10

Date of Submission:

Name of the Device

Trade Name: Common Name: Classification Name: Regulation Number:

SFI-Bar® Abutment, Dental, Endosseous implants Endosseous Dental Implant Abutment 21 CFR 872.3630

Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K083876 Predicate Device(s):

Description of the Device

Device Description:

The implant adapter (abutment) fit the Thommen SPI® Element Platform Ø 4.0 mm / the Neoss ProActive Implant Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm and the Straumann dental implants / ITI Dental Implant System® Standard Ø 4.1 and Ø 4.8 mm / Standard Plus Ø 4.1 mm and Ø 4.8 mm / Tapered Effect Ø 4.1 and Ø 4.8 mm and Regular Neck (RN) Ø 4.8 mm.

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Image /page/1/Picture/0 description: The image shows a logo with the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. To the left of the text is a stylized letter "M". The text and the letter are all in black. The logo appears to be for a company that deals with ashes and metals.

Intended Use of the Device:

The SFI-Bar® is intended to be used with the implant manufacturer's . (Table 1) implant to provide support for fixation of overdentures.

Table 1 Compatible Commercial Implant Manufacturers

Implant Company	Implant System	Implant Platform Diameter	Attribute	Candidates	Predicate Device
Thommen Medical	SPI® Element Platform	4.0 mm		SFI-Bar® Implant adapterStraumann®andSFI-Bar® Implant adapter forNeoss Implant	SFI-Bar® Implant adapter SPI®Element PF Ø 4.0Already cleared in combinationwith the SFI-Bar®(K083876)
Neoss	Neoss ProActive Implant	3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm	Design / construction	Machined,screw-retained	Machined,screw-retained
Institut Straumann	ITI Dental Implant System®	Standard 4.1 and 4.8 mm /Standard Plus 4.1 and 4.8 mm /Tapered Effect 4.1 and 4.8 mm /Regular Neck (RN) 4.8 mm	Anatomical Site	Oral Cavity	Oral Cavity
Platform compatibility	ITI Dental Implant System®:Standard Ø 4.1 mm and Ø 4.8 mm/Standard Plus Ø 4.1 mm and Ø 4.8 mm /Tapered Effect Ø 4.1 mm and Ø 4.8 mm /Regular Neck (RN) Ø 4.8 mmNeoss ProActive Implant:Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm	Thommen Implant System:SPI® Element Platform Ø 4.0 mm
Device Material	Wrought Titanium-6Aluminium-4Vanadium ELI Alloy forSurgical Implant applications	Wrought Titanium-6Aluminium-4Vanadium ELI Alloy forSurgical Implant applications
Indications for Use	The SFI-Bar® is intended to beused with the implantmanufacturer's (Table 1)implant to provide support forfixation of overdentures:	The SFI-Bar® is intended to beused with the SPI ElementPlatform 4.0 mm implant toprovide support for fixation ofoverdentures.
Operating principle /Basic Design	Impression taking: Optional,preassembled (plug-inconnection).Abutment implant connection:Screw fixation.Connecting principle tooverdenture: Retentive system.Bar fixation on implant:Screwed.Function: Stabilization and	Impression taking: Optional,preassembled (plug-inconnection).Abutment implant connection:Screw fixation.Connecting principle tooverdenture: Retentive system.Bar fixation on implant:Screwed.Function: Stabilization and

Summary Technological Characteristics:

Comparison /Compatibility Substantially Equivalence: The proposed implant adapters are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and manufacturing procedures are the same as the predicate device.

The material of the implant adapters conform to ASTM F 136, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy for Surgical Implant applications (UNS R 56401). The parts for the SFI-Bar® System are manufactured from wires.

The proposed implant adapters are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and manufacturing procedures are the same as the predicate device.

To ensure compatibility the following process was carried out: The implant adapters are developed.and manufactured in close cooperation with the implant companies (see Table 1 , column "Implant Company").

There are Quality Agreements between Cendres + Métaux and the implant companies in place. Those agreements handle among other things the Design Control, Change Control, Complaint Handling and Post Market Surveillance.

Table 2 summarizes the substantial equivalence comparison to the predicate device:

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Table 2 Substantial Equivalence Comparison to Predicate Devices

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Special 510(k) - SFI-Bar® 510(k) Summary

Attribute	Candidates	Predicate Device
	primary splinting of implants.	primary splinting of implants.
	Countering forces that woulddislodge the denture,distribution of shear forces,resilience compensation.	Countering forces that woulddislodge the denture,distribution of shear forces,resilience compensation.
	Cleaning procedures for patient:Common procedure for oralhygiene.	Cleaning procedures for patient:Common procedure for oralhygiene.
	Patient handling:Common cleaning and insertion	Patient handling:Common cleaning and insertion
	of denture.	of denture.
Shelf life	95% after 10 years	95% after 10 years
Packaging, materials andprocesses	Produced on process orientatedCNC machines. The last step is	Produced on process orientatedCNC machines. The last step is
	a validated cleaning process(same processes).	a validated cleaning process(same processes).
	Packaging: Dentalblister,non-sterile.	Packaging: Dentalblister,non-sterile.

Performance Data:

Summary of Testing to Demonstrate Safety and Effectiveness / Conclusion:

Torque tests, application testing and functional testing have been conducted to evaluate the performance characteristics of the additional SFI-Bar®. The test methods used were the same as in the predicate device. Testing has shown that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®. The acceptance criteria were met.

Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples. Fatigue testing was not done as the basic design is the same than the predicate device. The evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." Torque tests, application and functional tests have been carried out.

The summary of technological characteristics as well as the torque test, application and functional testing indicate that the device is safe and effective for its intended use and performs as well or better than the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol with three curved lines, which is the official symbol of the department.

Public Health Service

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

Mr. Tanja Bongni Consultant Regulatory Affairs Cendres & Metaux SA Rue De Boujean 122 Biel/Bienne Switzerland 2501

DEC - 3 2010

Re: K102382

Trade/Device Name: SFI-Bar® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 21, 2010 Received: November 5, 2010

Dear Mr. Bongni:

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. Bongni

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/ReportalProblem/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 vours.

h 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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20.09.2010

Indications for Use Statement

510(k) Number:

K102382

Device Name:

SFI-Bar®

Indications for Use:

The SFI-Bar® is intended to be used with the implant manufacturer's (Table 1) implant to provide support for fixation of overdentures.

DEC

ന്ന
1

2010

612387

Table 1 Compatible Commercial Implant Manufacturers

Implant Company	Implant System	Implant PlatformDiameter
Thommen Medical	SPI® ElementPlatform .	4.0 mm
Neoss	Neoss ProActiveImplant	3.5 / 4.0 / 4.5 / 5.0 /5.5 mm
Institut Straumann	ITI Dental ImplantSystem®	Standard 4.1 and 4.8mm /Standard Plus 4.1 and4.8 mm /Tapered Effect 4.1 and4.8 mm /Regular Neck (RN) 4.8mm

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Üff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Prescription Use X OR 510(k) NumbeQver-The-Counter

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.)