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The Encore Anterior Spinal Staple System is intended for anterior vertebral body fixation to the T3-L5 spine. This system is indicated to be used with an anterior spinal system that consists of screws that are between 6.0 and 6.5mm diameter manufactured out of Ti alloy.

The anterior vertebral body staple is designed to work in conjunction with the any existing spinal fixation systems utilizing 6.0mm to 6.5mm titanium screws. The staples are manufactured from Titanium alloy and are available as a single or double staple. The single staple has one hole for screw fixation with a 6.0mm -6.5mm titanium screws. The double staples are designed in pairs with specific superior and inferior components. Each has two screw holes allowing screws to pass through at a converging angle.

This 510(k) submission document for the Encore Anterior Spinal Staple System does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on design, indications, and materials. It does not include specific performance metrics, acceptance criteria, or a report of a study designed to test these criteria.
• No Clinical Study Details: There is no mention of a clinical study, human reader study, or standalone algorithm performance study. The device is a spinal implant, which typically would involve mechanical testing for safety and effectiveness, but these details are not provided in this summary.
• No Ground Truth Information: Since no study is described, there's no information about how ground truth would be established for any test set (training or evaluation).

Limitations of the Provided Document:

The provided text is a standard 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of technical characteristics, materials, and intended use, rather than extensive new clinical performance data, especially for Class II devices like this spinal fixation system.

Therefore, I cannot provide the requested information because the document does not contain it.

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