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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.

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