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The Graft Harvesting Sawblades are indicated for use as a power accessory in surgical procedures where it is necessary to cut a circular bone plug.

The Graft Harvesting Sawblade is a circular, two-piece, oscillating harvesting sawblade to create a precision circular bone plug 9-11 mm in diameter by 20-30 mm in length. The sawblades will be supplied either sterile for single use, or nonsterile and resterilizable. The Graft Harvesting Sawblade is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.

Based on the provided text, the document is a 510(k) Summary for a medical device called "Graft Harvesting Sawblade." This document describes the device, its intended use, and its substantial equivalence to a predicate device (Stryker Sawblade) for regulatory purposes. However, it does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) summary is a regulatory filing that demonstrates substantial equivalence to a legally marketed predicate device, rather than a detailed report of a new clinical study with specific performance metrics against acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

The document focuses on regulatory approval, not on the detailed results of a performance study.

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