The SternSnap Angled 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 SternSnap Angled Attachment is compatible with Sterngold SFI Abutments.

Device Description

The SternSnapAngled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. An appropriate height Sterngold SFI Abutment is screwed into an endosseous implant. A SternSnap Angled Attachment is screwed into the SFI Abutment. The SternSnap Angled Attachment can be manually pivoted on the hemispherical occlusal of the SFI Abutment until alignment is achieved. A retaining cap is processed into the denture. The retention cap engages the outside of the modified ball shape and allows retention of the prosthesis to the denture.

The proposed device is intended for angulation of divergent implants.

The SternSnap Angled Attachment can be pivoted from a central, 0 degree, position up to and including 17 degrees. It can also be rotated through 360 degrees. Therefore, two SternSnap Attachments can align two implants that are up to and including 34° out of parallel. The SternSnap Angled Attachment is only to be used with Sterngold SFI Abutments.

AI/ML Overview

The provided text is a 510(k) summary for the "SternSnap Angled Attachment." This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study might for a novel diagnostic algorithm.

Therefore, the requested information elements related to algorithms, ground truth, expert adjudication, multi-reader studies, and training sets are not applicable to this type of regulatory submission and device.

However, I can extract the relevant information regarding acceptance criteria and the non-clinical studies performed for this device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Characteristic	Reported Device Performance (Non-Clinical Testing)
Connection Reliability	Developed by analyzing SFI Abutment specifications. Dimensional verification against drawing, and fit checks to ensure reliable and functional connection.
Prosthetic Screw Tightness	Remained tightened to the initial torque after 10,000 cycles (Cyclic Load testing).
Angled Attachment Orientation	Still in original orientation after 1,000 cycles (Cyclic Load testing).
Retention Force	Level of retention was acceptable (Retention force testing). Specific values are mentioned in the "Summary Technological Characteristics" table, but not as explicit acceptance criteria for the SternSnap itself like "must be >= X N". The table shows "Up to 4.0 lb (17.8 N)" as its general retention force.
Angulation Capability	Can be pivoted from 0 to 17 degrees. Can be rotated 360 degrees. Allows alignment of two implants up to 34° out of parallel. (This is a design feature, confirmed by dimensional/functional checks).

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

Sample Size: Not explicitly stated as a number of devices tested. The non-clinical tests likely involved a representative sample of manufactured devices.
Data Provenance: The studies were non-clinical bench tests performed by the manufacturer, Sterngold Dental, LLC, or referenced data from Cendres & Metaux, SA for predicate devices. There is no mention of country of origin for the data (beyond the companies' locations) or whether it was retrospective/prospective, as these are clinical study terms.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not Applicable. This is a mechanical device, and "ground truth" as typically defined for AI algorithms (e.g., expert consensus on medical images) does not apply. Performance was assessed through engineering and mechanical testing methodologies.

4. Adjudication Method for the Test Set

Not Applicable. See point 3. Testing results were evaluated against engineering specifications and industry standards/guidance.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a non-AI, non-diagnostic medical device. No human readers or AI assistance are involved in its primary function or evaluation.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

Not Applicable (in the AI/clinical sense). For this device, "ground truth" would be established through engineering specifications, material properties, and validated bench testing protocols (e.g., ASTM standards for cyclic loading, torque retention measurements, dimensional accuracy verification).

8. Sample Size for the Training Set

Not Applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

Not Applicable. See point 8.

Summary

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

June 11, 2015

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

Re: K150250

Trade/Device Name: SternSnap Angled Attachment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 4, 2015 Received: May 6, 2015

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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K150250 510(k) Number (if known):

Device Name: SternSnap Angled Attachment

Indications for Use:

The SternSnap Angled Attachment is compatible with 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 × (Part 21 CFR 801 Subparts D) AND/OR

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

ਨ 2.

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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:	June 3, 2015
Trade Name:	SternSnap Angled Attachment
Common Name:	Dental Attachment
Classification Name:	Endosseous Dental Implant Abutment
Classification:	21 CFR 872.3630, Class II
Product Code:	NHA

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

Trade Name	510(k) No.	Manufacturer	Manufacturer
Straight Stud Attachment	K142407	Sterngold Dental, LLC	Primary Predicate
SFI Bar® Implant Abutments	K130183 and K132814	Sterngold Dental, LLC	Reference Predicate
SFI Anchor	K130618	Cendres & Metaux, SA	Reference Predicate
SFI Bar	K131526	Cendres & Metaux, SA	Reference Predicate

Description of Device:

The proposed device is intended for angulation of divergent implants.

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The SFI abutments are compatible with several implant systems and have been previously cleared under K130183 and K132184 - SFI Bar® Implant Abutments.

Intended Use of the Device:

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

The SternSnap Angled Attachment is compatible with 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.

Attributes	Proposed Device	Primary PredicateDevice	Reference PredicateDevice	Reference PredicateDevice	Reference PredicateDevice
	SternSnap AngledAttachmentSterngold Dental, LLC	Straight StudAttachmentSterngold Dental, LLCK142407	SFI ImplantAbutmentsSterngold Dental, LLCK130183, K132814	SFI AnchorCendres & Metaux,SAK130618	SFI BarCendres & Metaux,SAK131526
Device Material	Wrought Titanium-6AL-4Vanadium ELI Alloy	Wrought Titanium-6AL-4 Vanadium ELI Alloy	Wrought Titanium-6AL-4 VanadiumELI Alloy	Wrought Titanium-6AL-4 Vanadium ELIAlloy	Titanium
Manufacturing	Machined	Machined	Machined	Machined	Machined
Retentive Force	Up to 4.0 lb (17.8 N)	Up to 4.0 lb (17.8 N)	Up to 4.5 lb (20 N)	Up to 3.93 lb (17.5 N)	N/A
OperatingPrinciple	Screw fixation to SFIAbutment. Connectingprinciple to overdenture:Retentive system	Screw fixation to SFIAbutment. Connectingprinciple to overdenture:Retentive system	Screw fixation toImplant.Connecting principleto overdenture:Retentive system	Screw fixation toImplant.Connecting principleto overdenture:Retentive system	Screw fixation toImplant.Connecting principleto overdenture:Retentive system
Indications forUse	Intended for the fixationof dental prostheses tocorresponding dentalimplants.	Intended for the fixationof dental prostheses tocorresponding dentalimplants.	Intended for thefixation of dentalprostheses tocorresponding dentalimplants.	Intended for thefixation of dentalprostheses tocorresponding dentalimplants.	Intended to providesupport for thefixation of dentalprostheses tocorresponding dentalimplants.

Non-Clinical Performance Data:

The specifications for a reliable connection between the SternSnap Angled Attachment and the SFI implant abutments were developed by analyzing the SFI Abutment specifications. Nonclinical 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 SternSnap Angled Attachment screw section, dimensional verification against drawing, and fit checks of angled attachment to SFI abutment to ensure connection was reliable and functional.

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Review of fatigue testing data performed on the Angled SFI Bar by Cendres & Metaux showed the device being tested "with an angle of 30° to the implant axes". The SFI abutments support the pivoting ball component of the SFI Bar. This demonstrates that the proposed device is substantial equivalent to its predicates.

Cyclic Load testing was conducted to ensure prosthetic screw would remain tightened to the initial torque after 10,000 cycles and angled attachment would still be in their original orientation after 1,000 cycles. 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 SternSnap Angled Attachment is equivalent in performance characteristics to the predicate devices.

Substantial Equivalence: The summary of technological characteristics and performance testing indicate that the device is substantially equivalent to its predicate devices. The intended use and technological characteristics are the Straight Stud Attachment previously cleared under K142407.

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.)