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The Stern Micro ERA System is a resilient retention device for dental prosthesis, designed to be used in restoration of removable dentures.

Device consists of a series of nylon male attachments in six variable sizes to provide six levels of retention. The six levels of retention are color coded - white, orange, blue, gray, yellow, and red (in order of increasing degrees of retention). Variations in the degree of retention are incorporated to facilitate requirements of individual patients. It also includes a black processing (also referred to as fabricating) male that is not used in the mouth for retention of the finished denture, but only used as a tool to incorporate the final snap-in male into the finished dental appliance. A resin female is also incorporated in this system, along with stainless steel and titanium alloy instruments.

The provided document is a 510(k) summary for the Stern Micro ERA Attachment System, a dental device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, this document is a regulatory submission for premarket notification, demonstrating substantial equivalence to a predicate device. It explicitly states: "This submission is a Special 510(k): 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 FDA's guidance document entitled Premarket Notification 510(k): Regulatory Requirements for Medical Devices."

The conclusion further clarifies: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Stern Micro ERA System has been shown to be safe and effective for its intended use."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a previously approved device (Stern ERA System – 510(k) No. K 913348) rather than presenting a performance study against specific acceptance criteria.

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