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This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.

A disposable single use Biopsy Needle

I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for the BONETRAP Bone Marrow Biopsy Needle. The document is a 510(k) summary and an FDA approval letter, which primarily focus on the device's substantial equivalence to a predicate device and its indications for use, not on a detailed performance study with specific metrics and methodologies.

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The boneTRAP is designed for use in various oral surgical procedures (implant surgery, periodontal surgery, etc.) where the oral surgeon desires to collect a patient's own bone particles and other tissue fragments for later use in bone or tissue transplantation.

boneTRAP is a sterile, disposable plastic trap for collecting bone particles.

The provided text is a 510(k) premarket notification letter from the FDA regarding the "BoneTRAP" device. This type of document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot extract the requested information from the given text. The letter only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include technical specifications, study methodologies, or performance metrics.

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