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The Orion Medical Disposable Brain Biopsy Needle is an aspiration biopsy needle to remove and sample tissue within the brain in conjunction with a sterotactic head frame. The following statement describes the indications for use of Orion Medical's 14 gauge, and 18 gauge sterotactic disposable brain biopsy needle:

• Sterotactic biopsy needle used to sample brain tissue or to extract brain tissue samples to . determine tissue abnormality or any deviation from healthy brain tissue.
• . Tissue samples are extracted via the cannula using a syringe to aspirate. The cannula is then removed and the tissue sample is placed on a glass slide or sample dish, which is sent to anatomical pathology for smear analysis to determine tissue type.
• . Needle to be used in conjunction with a sterotactic frame with a center-of-the-arc of 21cm. The needles are 21cm from the hub of the needle to the sharp front cutting edge.

The Orion Medical Inc. three piece disposable Brain Biopsy Needle for sampling brain tissue is to be used in conjunction with a sterotactic head frame. The Orion Medical disposable Brain Biopsy Needle is inserted in the brain through a burr hole via a sterotactic head frame to a desired target that is obtained by a CT image. Tissue samples are obtained by aspirating through the Orion Medical disposable Brain Biopsy Needle is then removed from the brain and the sterotactic system and the sample is expelled from the brain biopsy needle onto a slide for analysis. The Orion Medical disposable Brain Biopsy Needle is similar in geometry, safety, function, and intended use as currently available brain biopsy needles.

The provided text is a 510(k) Summary for a medical device (Orion Medical Inc. Disposable Brain Biopsy Needle) and does not describe any acceptance criteria or studies to prove the device meets them.

The document states that the device is "substantially equivalent in geometry, safety, function, and intended use as currently available brain biopsy needles." This is the basis for its 510(k) clearance, meaning it was compared to predicate devices already on the market, rather than requiring new performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text as it is not present.

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