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

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving compliance for the SFI-Bar® device:

The provided document describes the 510(k) premarket notification for the SFI-Bar® device, a dental implant abutment. It seeks to establish substantial equivalence to predicate devices, rather than proving performance against novel acceptance criteria in a comprehensive clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar® and that acceptance criteria were met. However, the document does not explicitly list specific numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating equivalence to the predicate device.

The "Performance Data" section mentions:

Validation of Sterilization for metallic components.
Evaluation of the intended manual disinfection procedure with SFI-Bar® Retention inserts G.
Application and functional testing based on literature research.

The key acceptance criterion seems to be: "The SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®."

Acceptance Criteria (Implied)	Reported Device Performance
Sterilization validated for metallic components.	Validation of Sterilization has been conducted.
Intended manual disinfection procedure evaluated.	Evaluation of the intended manual disinfection procedure with SFI-Bar® Retention inserts G. has been conducted.
Application and functional testing consistent with predicate.	Application and functional testing based on literature research have been conducted. The test methods used were the same as in the predicate device.
Overall performance equivalent to the predicate SFI-Bar®.	Testing has shown that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®.
Device is safe and effective for its intended use.	The summary of technological characteristics indicates that the device is safe and effective for its intended use and performs as well or better than the predicate devices.
Ability to provide support for fixation of overdentures with compatible implant systems.	The SFI-Bar® is intended to be used with the implant manufacturer's (TABLE A) implant to provide support for fixation of overdentures. (Supported by technical compatibility and material equivalence.)

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

The document explicitly states: "Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary."

This indicates that a "test set" in the sense of a patient cohort or a large sample for a clinical trial was not used for this submission. The testing performed was non-clinical.

Sample Size for Test Set: Not applicable in the context of clinical or large-scale performance testing. The "test samples" mentioned in the context of "analysis of platforms to identify worst-case test samples" would likely refer to physical samples or configurations chosen for non-clinical engineering tests (e.g., sterilization, disinfection). The specific number of these non-clinical worst-case samples is not provided.
Data Provenance: The submission is from Cendres+Metaux SA, Biel/Bienne, Switzerland. The non-clinical testing was conducted by the manufacturer, but the location where the tests were performed is not specified. The data is retrospective in the sense that it's based on existing designs and literature, and performed prior to this submission for regulatory clearance.

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

Not applicable. As clinical testing was not performed and the submission relies on demonstrating substantial equivalence through non-clinical data and comparison to predicate devices, there was no "ground truth" to be established by experts in a clinical context for a test set. The validation and evaluation mentioned primarily concern manufacturing processes and materials.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

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

Not applicable. This device is a dental implant abutment, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given the nature of the device and the submission, the "ground truth" relied upon is primarily:

Engineering and material standards (e.g., ASTM F 136 for Titanium alloy).
Performance characteristics of legally marketed predicate devices (K073628, K083876, K102382) as established through their prior regulatory clearances.
Scientific literature research supporting application and functional principles.
Validation of manufacturing processes (sterilization, cleaning).

There isn't "ground truth" in the sense of clinical outcomes or expert consensus on diagnostic interpretations.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary: The submission for the SFI-Bar® focuses on demonstrating substantial equivalence to existing predicate devices, leveraging non-clinical testing, material standards, and literature review. It does not involve new clinical trials, expert consensus, or AI performance metrics.

Summary

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2011 12

K1113910

Attachment: 510(k) Summary

Applicant's Name and Address

Submitter:

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

Contact Person:

Tanja Bongni Consultant Regulatory Affairs

Date of Submission:

May 09, 2011

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)

Predicate Device(s):

K073628, K083876, K102382

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.

The implants (min. 2) in the mandible can be fitted with the SFI-Bar® immediately after implantation, provided the following criteria are met:

Implant manufacturers permit immediate loading in their -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------system.
No necessity for simultaneous guided bone regeneration; -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------implants surrounded on all sides by local bone.
Implant insertion torque min. 35 Ncm.
All parts are sterilized or disinfected.
Pull-of strength during osseointegration < 20 N.

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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 is in a sans-serif font and is black. The logo appears to be for a company that deals with ashes and metals.

K111390

Intended Use of the Device:

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

TABLE A 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

Summary Technological Characteristics:

Comparison /Compatibility Substantially Equivalence: The proposed labelling change to the SFI-Bar® is 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 A, column "Implant Company").

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

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Image /page/2/Picture/0 description: The image shows a logo for Cendres+ Metaux. The logo consists of a stylized letter "M" on the left, followed by the words "CENDRES+" on the top line and "METAUX" on the bottom line. The text is in a simple, sans-serif font and is all in black.

・・

K11.1390

TABLE B summarizes the substantial equivalence comparison to the predicate device:

TABLE B Substantial Equivalence Comparison to Predicate Devices:

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K111390

Performance Data:

Validation of Sterilization for the metallic components, evaluation of the intended manual disinfection procedure with SFI-Bar® Retention inserts G. application and functional testing based on literature research have been conducted to evaluate the performance characteristics of the 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.

Summary of Testing to Demonstrate 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 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." Application and functional tests are based on the predicate device and literature research. The summary of technological characteristics 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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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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters.

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

Ms. Tanja Bongni Consultant Regulatory Affairs Cendres-Metaux SA Rue de Boujean 122 Biel/ Bienne Switzerland 2501

SEP 12 2011

Re: K111390

Trade/Device Name: SFI-Bar® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 23, 2011 Received: August 29, 2011

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 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 - Ms. 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/MicdicalDevices/Safety/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,

Nh 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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KIIBTO

Attachment: Indications for Use Statement

Device Name:

SFI-Bar®

Indications for Use:

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

Implant Company	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 /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

TABLE a Compatible Commercial Implant Manufacturers

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

Suan Suany

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K111390

Prescription Use x

Over-The-Counter Use

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.)

Attribute	Candidates	Predicate Device	Predicate Device
510(k) Number	SFI-BarⓇ	SFI-BarⓇK083876,K102382	RN synOctaⓇK073628
Design / construction	Machined, screw-retained	Machined, screw-retained	Machined, screw-retained
Anatomical Site	Oral Cavity	Oral Cavity	Oral Cavity
Platform compatibility	ITI Dental ImplantSystem®: 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 mm	ITI Dental ImplantSystem®: 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 mm	ITI Dental ImplantSystem®:Standard Ø 4.8 mm RNand Ø 6.5 mm WN /Standard Plus Ø 4.8 mmand Ø 6.5 mm WN/Tapered Effect Ø 4.8 mmand Ø 6.5 mm WN
	Neoss ProActive Implant:Ø 3.5 / 4.0 / 4.5 / 5.0 /5.5 mm	Neoss ProActive Implant:Ø 3.5 / 4.0 / 4.5 / 5.0 /5.5 mm
	Thommen Implant System:SPI® Element Platform Ø4.0 mm	Thommen Implant System:SPI® Element Platform Ø4.0 mm
Device Material	Wrought Titanium-6Aluminium-4VanadiumELI Alloy for SurgicalImplant applications	Wrought Titanium-6Aluminium-4VanadiumELI Alloy for SurgicalImplant applications	Titanium abutment,Ceramicor sleeve
Manufacturer	CENDRES+METAUX SA	CENDRES+METAUX SA	Institut Straumann AG
Indication for Use	The SFI-Bar® is intendedto be used with theimplant manufacturer's(see TABLE A) implant toprovide support for fixationof overdentures.	The SFI-Bar® is intendedto be used with theimplant manufacturer's(see TABLE A) implant toprovide support for fixationof overdentures.	Abutments are intended tobe placed into dentalimplants to providesupport for prostheticreconstructions such ascrowns, bridges andoverdentures.
Operating principle /Basic Design	Impression taking:optional,preassembled (plug-inconnection).Abutment implantconnection: screw fixation.Connecting principle tooverdenture: retentivesystem.Bar fixation on implant:screwed.Function: stabilization andprimary splinting ofimplants.Countering forces thatwould dislodge the	Impression taking:optional,preassembled (plug-inconnection).Abutment implantconnection: screw fixation.Connecting principle tooverdenture: retentivesystem.Bar fixation on implant:screwed.Function: stabilization andprimary splinting ofimplants.Countering forces thatwould dislodge the	Impression taking:required.Abutment Implantconnection: Screw fixation.Bar connection: soldered.Connecting principle tooverdenture: retentivesystem.Bar fixation on implant:screwed.Countering forces thatwould dislodge the

Attribute	Candidates	Predicate Device	Predicate Device
	denture, distribution ofshear forces, resiliencecompensation.	denture, distribution ofshear forces, resiliencecompensation.	denture, distribution ofshear forces, resiliencecompensation.
	Cleaning procedures forpatient: commonprocedure for oral hygiene.	Cleaning procedures forpatient: commonprocedure for oral hygiene.	Cleaning procedures forpatient: commonprocedure for oral hygiene.
	Patient handling:common cleaning andinsertion of denture.	Patient handling:common cleaning andinsertion of denture.	Patient handling:common cleaning andinsertion of denture.
Shelf life	95% after 10 years	95% after 10 years	95% after 10 years
Packaging, materials andprocesses	Produced on processorientated CNC machines.The last step is a validatedcleaning process (sameprocesses).	Produced on processorientated CNC machines.The last step is a validatedcleaning process (sameprocesses).	Produced on processoriented CNC machines.The last step is a validatedcleaning process (sameprocess).
	Packaging: dental blister,non-sterile.	Packaging: dental blister,non-sterile.	Packaging:non-sterile.
Abutment / implantadapter used in contextwith the immediateloading.	Yes (this submission).	No.	Yes. Abutment cleared forimmediate loading.