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The Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated:

· For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis

· For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis

· For single tooth or multiple unit prosthesis

The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded. root-form endosseous implants that will be available is a variety of sizes to suit individual user/patient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration.

The proposed implants are compatible with standard, regular platform (4.1mm), external-hex (antirotational) abutments such as the currently marketed Sterngold-Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants.

The Sterngold Acid Etch Implants will be available in the following sizes:

Diameter (mm): 3.75, 4.00, 5.00
Overall Length (mm): 8.5, 10, 11.5, 13, 15, 18 (for 3.75mm diameter); 8.5, 10, 13, 15 (for 4.00mm diameter); 8.5, 10 (for 5.00mm diameter)

The provided text is a 510(k) summary for a dental implant system. It describes the device, its indications for use, and states that it relies on substantial equivalence to predicate devices and conformity with FDA guidance documents regarding endosseous implants.

However, the document does not contain information about acceptance criteria, specific device performance measurements, detailed study designs (such as sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

Therefore, I cannot provide the requested information. The 510(k) summary explicitly states:

"This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Sterngold has provided information to demonstrate conformity with the following standards:

• Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants (FDA Guidance)
• Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996)"

This indicates that the submission focuses on demonstrating substantial equivalence through adherence to existing guidance and comparison to predicate devices, rather than presenting a de novo study with explicit acceptance criteria and performance data as might be found in a Premarket Approval (PMA) application or a more extensive clinical study write-up.

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