The Straight Stud Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

The Straight Stud Attachment is compatible with all Sterngold SFI Abutments.

Device Description

The attachment consists of a modified ball, which screws into an SFI Abutment and a retaining female, which is processed into the denture. The retaining female engages the outside of the ball shape and allows retention of the prosthesis to the denture.

Sterngold SFI abutments are compatible with several implant systems that have been previously cleared under K130183 and K132814 - SFI Bar® Implant Abutments.

The Straight Stud Attachment is a straight attachment and is not intended for angulation of divergent implants. It has a 0.048" hex for tightening to the SFI abutment.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Straight Stud Attachment) and does not describe acceptance criteria or a study proving that the device meets those criteria in the way typically expected for an AI/ML medical device. This document is for a mechanical dental device and the "performance data" refers to mechanical testing.

Therefore, many of the requested fields cannot be answered as they pertain to AI/ML device studies.

Here's an attempt to answer the questions based only on the provided text, recognizing its limitations:

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

The document mentions "specifications for a reliable connection" and "retention force testing was conducted to ensure level of retention was acceptable" and "dimensional verification against drawing." However, specific quantitative acceptance criteria and corresponding performance metrics are not provided in this summary.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Reliable connection with SFI implant abutments	"connection was reliable and functional"
Acceptable level of retention force	"level of retention was acceptable"
Adherence to dimensional specifications	"dimensional verification against drawing"
Equivalent performance to predicate devices	"Testing has shown that the Straight Stud Attachment is equivalent in performance characteristics to the predicate devices."

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: The document states "fit checks of attachment to SFI abutment on several samples." This is vague and does not provide a specific sample size.
Data provenance: Not specified. The testing is described as "Non-Clinical Performance Data," implying lab-based mechanical testing rather than human clinical data.

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. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here would be the physical properties and performance characteristics of the mechanical device, verified through engineering tests.

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

Not applicable for this type of mechanical device 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 is a mechanical dental device, not an AI/ML diagnostic tool.

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

No. This is a mechanical dental device. The "standalone" performance would be its mechanical function, which was evaluated non-clinically.

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

The "ground truth" for this device's non-clinical performance data would be:

Engineering specifications and drawings.
Physical measurements (dimensions, forces, material properties).
Functional requirements (e.g., ability to screw in, retention).

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML algorithm that requires training data.

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

Not applicable, as there is no training set for a mechanical device. The design specifications and material properties are established through standard engineering practices and regulatory requirements.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure, with three faces merging into one another. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

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

December 24, 2014

Sterngold Dental, LLC Maria Rao Director of Quality & Regulatory Affairs 23 Frank Mossberg Drive Attleboro, Massachusetts 02703

Re: K142407

Trade/Device Name: Straight Stud Attachment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 25, 2014 Received: November 26, 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.

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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 (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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Erin I. Keith -S

Erin I. Keith, M.S. 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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510(k) Number (if known): K142407

Device Name: Straight Stud Attachment

Indications for Use:

The Straight Stud Attachment is compatible with all Sterngold SFI Abutments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subparts D) AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

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510(k) Summary

Sponsor:	Sterngold Dental, LLC23 Frank Mossberg DriveAttleboro, MA 02703
Contact:	Maria Rao, QA/RA DirectorPh: 508-226-5660 ext 1206
Date:	November 25, 2014
Trade Name:	Straight Stud Attachment
Common Name:	Dental Attachment
Classification Name:	Endosseous dental implant abutment21 CFR 872.3630
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II
Product Code:	NHA

Legally Marketed Device to which Equivalence is claimed (Predicate Devices):

Trade Name	510(k) No.	Manufacturer
SFI Bar® Implant Abutments	K130183 and K132814	Sterngold Dental, LLC
SFI Anchor	K130618	Cendres & Metaux, SA
Locator Implant Anchor	K994257	Zest Anchors, Inc.

Description of Device:

Sterngold SFI abutments are compatible with several implant systems that have been previously cleared under K130183 and K132814 - SFI Bar® Implant Abutments.

The Straight Stud Attachment is a straight attachment and is not intended for angulation of divergent implants. It has a 0.048" hex for tightening to the SFI abutment.

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Intended Use of the Device:

The Straight Stud Attachment is compatible with all Sterngold SFI Abutments.

Summary Technological Characteristics:

The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices - titanium alloy, polyurethane (brown, green, yellow, black) were also used in legally marketed predicate devices.

A Failure Mode and Effects Analysis (FMEA) was performed to ensure safety of device.

Substantial Equivalence:

The proposed Straight Stud Attachment 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 devices. To ensure compatibility, the Straight Stud Attachment was designed, and manufactured according to manufacturer's specifications and controlled procedures and validated following a validation protocol in accordance with Design Control requirements per FDA CFR820.30.

Non-Clinical Performance Data:

The specifications for a reliable connection between the Straight Stud Attachment and the SFI implant abutments were developed by analyzing the SFI Abutment specifications. Non-clinical test data was used to support the substantial equivalency. Clinical testing was not necessary. Non-clinical testing consisted of analysis of the SFI abutment top portion (head) and Stud Attachment screw section, dimensional verification against drawing, and fit checks of attachment to SFI abutment on several samples to ensure connection was reliable and functional.

Retention force testing was conducted to ensure level of retention was acceptable.

Evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

Testing has shown that the Straight Stud Attachment is equivalent in performance characteristics to the predicate devices.

Conclusion as to Substantial Equivalence:

Based on the technological characteristics, non-clinical functional testing and comparison of indications for use, it can be concluded that the Straight Stud Attachment is substantially equivalent to the predicate devices.

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.)