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 (abutinent) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SFI-Bar® based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Characteristics)	Reported Device Performance
Torque tests	Met acceptance criteria
Application testing	Met acceptance criteria
Functional testing	Met acceptance criteria
Performance equivalence to predicate SFI-Bar®	Equivalent

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

The document does not explicitly state a separate "test set" and its sample size in the context of clinical data for the SFI-Bar®. The performance evaluation relies on non-clinical test data.

Data Provenance: The testing was conducted as part of a 510(k) submission, originating from Switzerland (Cendres + Métaux SA, Biel/Bienne, Switzerland). The data is retrospective in the sense that it's an evaluation against established performance metrics and comparison to predicate devices, rather than a prospective clinical trial.

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

This information is not provided as the ground truth for this device's performance evaluation was based on engineering and performance testing rather than expert-derived clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation did not involve human interpretation or adjudication processes like those in clinical image analysis studies. The adjudication for performance was based on meeting technical specifications from engineering tests.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the SFI-Bar®.

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

This concept is not applicable to the SFI-Bar®. The device is a physical dental abutment, not an algorithm. The performance evaluation was of the physical device's mechanical properties and function.

7. The Type of Ground Truth Used

The ground truth for evaluating the SFI-Bar®'s performance was based on:

Engineering specifications and standards: Adherence to established mechanical properties (e.g., torque, application, functional requirements).
Performance characteristics of predicate devices: The SFI-Bar® was compared for substantial equivalence to legally marketed predicate devices, meaning their established safe and effective performance served as a benchmark.

8. The Sample Size for the Training Set

This information is not applicable. The SFI-Bar® is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as there is no "training set" for this device.

Summary

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KBIS26

Image /page/0/Picture/1 description: The image shows a logo with the text "CENDRES+ MÉTAUX". To the left of the text is a stylized symbol that appears to be a combination of the letters 'C' and 'M'. The text is in a bold, sans-serif font, with "CENDRES" on top and "MÉTAUX" below it. The overall design is simple and modern.

May 23, 2013

Image /page/0/Picture/4 description: The image shows a logo with the letters "CM" on the left and the words "CENDRES" and "MÉTAUX" on the right. The letters "CM" are in a bold, sans-serif font and are stacked on top of each other. The word "CENDRES" is in a smaller, sans-serif font and is stacked on top of the word "MÉTAUX". The logo is black and white.

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

May 23, 2013

510(k) Summary

Applicant's Name and Address

Submitter:

Rue de Boujean 122 2501 Biel/Bienne, Switzerland Phone: +41 58 360 20 00 Fax: +41 58 360 20 10

Cendres + Métaux SA

Tanja Bongni Regulatory Affairs Manager

Date of Submission:

Name of the Device

Contact Person:

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

Predicate Device(s):

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

Legally Marketed Device to which Equivalence is Claimed (Predicate Device)

May 23, 2013

K083876, K111390, K071638, K042429, K073268, K053152, K073282

Description of the Device

Device Description:

The implant adapter (abutment) fit the Thommen SPI® Element Plattorn Ø 4.0 mm / the Neoss ProActive Implant Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm and the Straumann cental implants / ITI Dental Implant System@ Standard Ø 4.1 and Ø 4.8 mm / Standard Plus Ø 4.1 mm and 0 4.8 mm / Tapered Effect 0 4.1 and 0 4.8 mm and Regular Neck (RN) Ø 4.8 mm and the BioHorizons Implant Systems Tapered Internal Implants / Internal Implants - bone level / Single-stage Implants - tissue level (Implant Platform: Ø 3.5 mm, Ø 4.5 mm, Ø 5.7 mm).

Page 1 of 6

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May 23, 2013

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

May 23, 2013

Intended Use of the Device:

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

Table 1 Compatible Commercial Implant Manufacturers:

Implant Manufacturer	Implant System	Implant Platform Diameter:
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
Thommen Medical	SPI® Element Platform	4.0 mm
Neoss	Neoss ProActive Implant	3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm
BioHorizons	Tapered internal Implant - bonelevel	Ø 3.5 mm, Ø 4.5 mm, Ø 5.7 mm
	Internal Implants -bone level
	Single-stage Implants - tissuelevel

Summary Technological Characteristics:

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 devices.

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

Comparison /Campatibility Substantially Equivatence:

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-Mistaux and the implant companies in place. Those agreements handle arnong other things the Design Control. Change Control, Complaint Handling and Post Market Surveillance,

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

Page 2 of 6

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May 23, 2013 100

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Traditional 510(k) – SFI-Bar® 510(k) Summary

. .

May 23, 2013

Table 2 Substantial Equivalence Comparison to Predicate Devices:

	SFI-Bar®	Predicate Devices		Comparison/Performance"Predicate Devices"
510(k) No.	Candidate	K083876,K111390	K071638,K042429,K073268,K053152,K073282
ProprietyName	SFI-Bar®	SFI-Bar®	"BioHorizonsTapered InternalImplant System","The ProdigySystem™ DentalImplants","BioHorizonsSingle-stageImplant","BioHorizonsSingle-stageImplant Systems","BioHorizonsInternal ImplantSystem"
Model no orSystem	05001022,05001021,05001020,05001019,05001023,05001027,05001026,05001025,05001024,05001028,05001032,05001031,05001030,05001029,05001033	05000576,05000577,05000578,05000579	Tapered internalImplants - bonelevel,$Ø$ 3.8 (y)./ 4.6 (g)/ 5.8 (h).Internal Implants -bone.level,$Ø$ 3.5 (y) / 4.0 (g)/ 5.0 (b) / 6.0 (b).Single- stageImplants - tissuelevel,$Ø$ 3.5 (y) / 4.0(y&g) / 5.0 (g&b) /6.0 (b).
CommonName:	Abutment forEndosseous Implant(Dental)	Abutment forEndosseous Implant(Dental)	Endosseous dentalimplant
Manufacturer	Cendres + MétauxSA	Cendres + Métaux SA	BioHorizonsImplant Systems,Inc.
ProductCodes	NHA	NHA	DZE	Both SFI-Bar®sare within thesame product

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May 23, 2013

Image /page/3/Picture/3 description: The image shows a logo with the letters "CM" on the left and the words "CENDRES+" and "MÉTAUX" on the right. The letters "CM" are in a bold, stylized font, and the words "CENDRES+" and "MÉTAUX" are in a smaller, sans-serif font. The logo is black and white. The plus sign is located to the right of the word "CENDRES".

Traditional 510(k) – SFI-Bar® 510(k) Summary

1000 - 1000

May 23, 2013

	SFI-Bar®	Predicate Devices		Comparison/Performance"Predicate Devices"
510(k) No.	Candidate	K083876,K111390	K071638,K042429.K073268.K053152.K073282
				code. All predicatedevices are withina dentalapplication.
RegulationIndicateduse	872.3630Intended to be usedwith the implantmanufacturer'simplant (Table 1) toprovide support forfixation ofoverdentures.	872.3630Intended to be usedwith the implantmanufacturer'simplant (Table 1:SPI® ElementPlatform 4.0 mmimplant) to providesupport for fixation ofoverdentures.	872.3640Dental implant	Equivalent toSFI-Bar®
Manu-facturingProcess	Machined. Surfacetreated (anodized).	Machined.	Machined. Surfacetreated (anodized).	All SFI-Bar®Implant adapter aremachined. Thenew devices withinthis submission arealso partiallyanodized. Theanodizationprocess has noinfluence on thesafety &effectiveness of thedevice. Therefore,it can be statedthat themanufacturingprocess isequivalent to theSFI-Bar®(predicate devices).Equivalent toSFI-Bar®BioHorizonsimplants are alsosurface treated(same color

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: ·

Traditional 510(k) Submission USA: SFI-Bar® Format: Based on STED (GHTF/SG1/N011:2008) ·

May 23, 2013

.....

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

: · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

May 23, 2013

	SFI-Bar®	Predicate Devices		Comparison/Performance"Predicate Devices"
510(k) No.	Candidate	K083876,K1.11390	K071638,K042429,K073268,K053152,K073282
OperatingPrinciple /BasicDesign	Impression taking:Optional,preassembled (plug-in connection).	Impression taking:Optional,preassembled (plug-inconnection).	Not relevant	≒ Equivalent toSFI-Bar®
	Abutment implantconnection: Screwfixation.	Abutment implantconnection: Screwfixation.
	Connecting principleto overdenture:Retentive system.	Connecting principleto overdenture:Retentive system.
	Cleaning proceduresfor patient: Commonprocedure for oralhygiene.	Cleaning proceduresfor patient: Commonprocedure for oralhygiene.
	Patient handling:Common cleaningand insertion ofprosthesis.	Patient handling:Common cleaning andinsertion of denture.
Materialsincorporatedinto keyfunctionalelements	Titanium	Titanium	Not relevant	≒ Equivalent toSFI-Bar®
Shelf Life	95% after 10 years	95% after 10 years	Not known byCendres + MétauxSA	≒ Equivalent toSFI-Bar®
Packagingandsterilization	Dentalblister, non-sterile.	Dentalblister, non-sterile.Tubular bag, non-sterile	Not relevant	≒ Equivalent toSFI-Bar®

Pertormance Data:

Torque tests, application lesting and lunctional lesting have been conducted to evaluate the performance characteristics of the additional SFI-Rarib. The test methods used were the same as in the predicate device. Testing has shown that the SFI-BarQi is equivalent in performance characteristics to the predicate SFI-Bair®. The acceptance culeria were met.

. Page 5 of 6

・

CONFIDENTIAL

. . . .

、

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May 23, 2013

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Traditional 510{k} - SFI-Bar® 510(k) Summary

May 23, 2013

Summary of Testing to Oernonstrate Safety and Effectiveness / Conclusion:

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 identity worst-case test samples. Faligue lesting was not done as the basic cesign is the same than the predicate device. The evaluation was based on FDA guidance "Class II Soccial 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 cevice is safe and . effective for its intended use and performis as well or better than the predicate devices.

Page 6 of 6

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 23, 2013

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

Cendres & Metaux SA Ms. Tanja Bongni Regulatory Affairs Manager Rue De Boujean 122 2501 Biel/Bienne, Switzerland

Re: K131526

Trade/Device Name: SFI-Bar® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosscous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 11, 2013 Received: September 13, 2013

Dear Ms. 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 cnactment 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 cither 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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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/MedicalDevices/ResourcesforYou/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/MedicallDevices/Safets/Reportal/roblem/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,

Richard C. Chapman 2013.09.23 13:19:52 -04'00'

for

Kwame Ulmer M.S. Acting Division 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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May 23, 2013

Indications for Use

KISIS26 5 10(k) Number (if known):

Device Name:

SFI-Bark

Indications for Use:

The SFI-Bans is intended to be used with the implant translations in the called in to provide support ler lixation of overdentures.

Only the imp ant systems listed in Table I may be used will SFI-Mar-y.

The compatible implant systems are specified in Table . below

Implant Manufacturer	Implant System	Implant Platform Diameter
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
Thommen Medica	SPI Element Platform	4.0 mm
Neoss	Neoss ProActive Implant	3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm
BioHorizons	Tapered Internal Implant - bone level	⌀ 3.5 mm, ⌀ 4.5 mm, ⌀ 5.7 mm
	Internal Implants - bone level
	Single-stage Implants - tissue level

Table I Compatible Implani Systems

AND / OR Prescription Jsc × (Pari 21 CFR 801 Subpart D)

Over-The-Counter Jsc (2) CFR 801 Subpart C)

(PLEASE DO NOT WRITE RELOW THIS : INE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CORH. Office of Device Evaluation (OOE)

Andrew I. Steen -S 2013.09.23 08:00:13 -04'00'

:Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Fage : ci l

K131524 510(k) Number:

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.)