The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.

Device Description

The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment.

The implant abutments fit Straumann Bone Level RP, Straumann Bone Level NP, Ankylos, Nobel 5mm Trilobe, Nobel Conical RP, Nobel Conical NP, Astra 4.5/5.0, Astra 3.5/4.0, Zimmer TSV 5.7mm.

There are nine (9) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [BD], [BE], [AE], [AN], [AY], [AY], [AJ], [AK], [BF]. Table 1 indicates which implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant.

The devices are supplied non-sterile, therefore there is no shelf life.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the SFI Bar® Implant Abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested categories for device performance, ground truth, and comprehensive study details are not applicable or available in this type of regulatory submission. The document primarily describes non-clinical testing to support the claim of equivalence.

Here's a breakdown based on the available information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Material Conformance: Material of implant abutments conforms to ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy.	The material of the implant abutments conform to ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy.
Performance Equivalence: Device performs equivalently to predicate SFI Bar® Implant Abutments.	Testing has shown that the SFI-Bar® Implant Abutments included in this application are equivalent in performance characteristics to the predicate SFI Bar®. The acceptance criteria were met. (Specific numerical performance criteria are not detailed in the document.)
Design and Manufacturing: Designed and developed, and manufactured according to manufacturer's specifications and controlled procedures. Validation protocol done in accordance with Design Control requirements per FDA CFR820.30.	The implant abutments were designed and developed, and manufactured according to manufacturer's specifications and controlled procedures. A validation protocol was done in accordance with Design Control requirements per FDA CFR820.30.
Non-clinical Test Methods: Application and functional testing done using the same test methods as in predicate devices.	The test methods used were the same as in predicate devices.
Worst-Case Sample Identification: Tolerance analysis of platforms performed to identify worst-case test samples.	Tolerance analysis of platforms -to-identify-worst-case-test-samples was performed.
Fatigue Testing: (Not applicable as noted in the document)	Fatigue testing .was-not-done as the basic design is the same as the predicate devices.
Torque Tests, Application and Functional Tests: Performed as part of non-clinical testing.	Torque tests, application and functional tests have been carried out.

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: Not explicitly stated as numerical counts of products tested. The document mentions "tolerance analysis of platforms -to-identify-worst-case-test-samples" which implies selected samples were tested, but the exact number isn't provided.
Data Provenance: Not specified. Given it's a US-based company submitting to the FDA, it's highly probable the testing was conducted in the US, but this is not explicitly stated. The testing is described as non-clinical, likely laboratory-based.
Retrospective or Prospective: Not applicable, as this refers to clinical studies, and only non-clinical testing was performed.

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)

Number of Experts & Qualifications: Not applicable. Non-clinical testing for equivalence does not typically involve expert consensus to establish a "ground truth" in the way clinical studies do. The "ground truth" for material specifications and performance would be established by engineering standards and internal company specifications.

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

Adjudication Method: Not applicable. This concept is relevant to clinical studies involving human interpretation or subjective assessments. Performance testing of abutments involves objective measurements against engineering specifications.

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

MRMC Comparative Effectiveness Study: No, this type of study was not done. The device is a dental implant abutment, not an AI-powered diagnostic tool.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. The device is a mechanical component (dental abutment), not an algorithm.

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

Type of Ground Truth: For the non-clinical testing, the "ground truth" would be engineering specifications, material standards (like ASTM F136), and validated test methodologies to assess physical properties and fit. There is no biological "ground truth" in the context of this 510(k) submission.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. The device is a manufactured medical device, not an AI/ML model that requires a training set.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary

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K13 27164

Fr: 2 5 2014

Sterngold Dental, LLC Abbreviated 510(k) Premarket Notification

September 6, 2013 SFI Bar® Implant Abutments for 9 Implant Platforms

510(k) Summary

Sponsor:	Sterngold Dental, LLC23 Frank Mossberg DriveAttleboro, MA 02703
Contact:	Maria Rao, QA/RA DirectorPh: 508-226-5660 ext 1206
Trade Name:	SFI Bar® Implant Abutments
Common Name:	Implant Abutments
Classification Name:	Endosseous Dental Implant Abutment
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II
Product Code:	NHA (21CFR 872.3630)

Legally Marketed Device to which Equivalence is claimed (Predicate Devices): Predicate Device(s): K130183, K102382.

K130183	SFI Bar® Implant Abutments for 7 Platforms
K102382	SFI Bar® Implant Adapter Straumann, SFI Bar® Implant Adapter Neo

Description of Device:

Device Description: The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment.

The implant abutments fit Straumann Bone Level RP, Straumann Bone Level NP, Ankylos, Nobel 5mm Trilobe, Nobel Conical RP, Nobel Conical NP, Astra 4.5/5.0, Astra 3.5/4.0, Zimmer TSV 5.7mm.

See table 1 for platform compatibility.

The devices are supplied non-sterile, therefore there is no shelf life.

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Abutment Insertion

Choose the abutment with the proper cuff height that fits on the existing implant. Abutment platforms should be 1 to 2 mm above the gingival level and approximately parallel to the occlusal plane. However, to allow the subsequent placement of the sections of SFI-Bar on top of these abutments so that the bars are approximately parallel to the occlusal plane, it may be necessary to choose some abutments with different heights. Abutments are screwed into each implant.

Intended Use of the Device:

Model Implant Brand Straumann Bone Level RC, Blue Sky Bio Square Taper RC Straumann Straumann Bone Level NC, Blue Sky Bio Square Taper NC Straumann Ankylos Ankvlos Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, Nobel Biocare Implant Direct 5.0 RePlant, BlueSky Bio 5.0 Trilobe Nobel Biocare Nobel Conical Connection RP Nobel Conical Connection NP, Blue Sky Bio Max Nobel Biocare Astra 4.5 / 5.0, Blue Skv Bio Conus 12 4.5 / 5.0 Astra Dental Astra 3.5 / 4.0. Blue Sky Bio Conus 12 3.5 / 4.0 Astra Dental Zimmer TSV 5.7mm, Implant Direct Legacy 5.7, BioHorizon 5.7 Zimmer Dental

The SFI-Bar® Implant Abutments are compatible with the following implant systems:

Summary Technological Characteristics:

The proposed implant abutments 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 abutments conform to ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy.

Comparison/Compatibility

Substantial Equivalence:

To ensure compatibility the following process was carried out: The implant abutments were designed and developed, and manufactured according to manufacturer's

specifications and controlled procedures. A validation protocol was done in accordance with Design Control requirements per FDA CFR820.30.

Table 2 summarizes the substantial equivalence comparison to the predicate devices.

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Performance Data:

Application and functional testing have been conducted to evaluate the performance characteristics of the SFI Bar® Implant Abutments. The test methods used were the same as in predicate devices. Testing has shown that the SFI-Bar® Implant Abutments included in this application are 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. The non-clinical testing consisted of tolerance analysis of platforms -to-identify-worst-case-test-samples ... Fatigue testing .was-not-done as the basic design is the same as the predicate devices. 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 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.

13.4

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

February 25, 2014

Sterngold Dental LLC Ms. Maria Rao Quality Assurance Director 23 Frank Mossberg Drive Attleboro, MA 02703

Re: K132814

Trade/Device Name: SFI Bar Implant Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 21, 2014 Received: January 22, 2014

Dear Ms. Rao:

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.

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

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Page 2 - Ms. Cheng

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 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.fda.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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/8 description: The image shows the name "Kwame O. Ulmer" in bold, black font. Below the name, there is a faded, patterned design that is difficult to discern. The letter "S" is located to the left of the design, also in bold, black font.

for

Erin I. Keith, M.S. Acting 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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Sterngold Dental, LLC Abbreviated 510(k) Premarket Notification

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.. . . . . .

September 6, 2013 SFI Bar® Implant Abutments for 9 Implant Platforms

INDICATIONS FOR USE STATEMENT

SECTION 2

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and the country of the country of the country of the country

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510(k) Number (if known): K132814

Device Name: SFI Bar® Abutments for 9 Implant Platforms

Indications for Use:

The SFI-Bar® Implant Abutments are compatible with the following implant systems:

Implant Brand	Model
Straumann	Straumann Bone Level RC, Blue Sky Bio Square Taper RC
Straumann	Straumann Bone Level NC, Blue Sky Bio Square Taper NC
Ankylos	Ankylos
Nobel Biocare	Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP,Implant Direct 5.0 RePlant, BlueSky Bio 5.0 Trilobe
Nobel Biocare	Nobel Conical Connection RP
Nobel Biocare	Nobel Conical Connection NP, Blue Sky Bio Max
Astra Dental	Astra 4.5 / 5.0, Blue Sky Bio Conus 12 4.5 / 5.0
Astra Dental	Astra 3.5 / 4.0, Blue Sky Bio Conus 12 3.5 / 4.0
Zimmer Dental	Zimmer TSV 5.7mm, Implant Direct Legacy 5.7, BioHorizon 5.7

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Mary S. Runner - S 2014.02.24 0.28.46 05.00 Over-the -Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart D) (Part 21 CFR 801 Subparts D) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. . ...

• • •

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.)