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The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set is intended for vertebral body access, biopsy and infusion during a vertebroplasty procedure.

The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set consists of a cannula with an accompanying inner stylet and an obturator. The device may include an additional inner biopsy needle and obturator. The cannula is available in several sizes (11, 13 or 15 gauge) and lengths (10 or 15 cm) with various cannula/stylet tip configurations. The additional inner biopsy needle is available in two sizes (14 or 16 gauge) and lengths (17.1 or 22.1 cm) with a trephine tip and functions coaxially with the cannula once the stylet is removed. A plastic, non-radiopaque needle holder is also available to aid with needle placement.

The provided document does not contain information related to software or AI/ML-driven medical devices. Therefore, it is impossible to extract the requested details such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document discusses a physical medical device, the "Osteo-Site Bone Biopsy Needle and the Osteo-Site Bone Biopsy Needle Set," and its substantial equivalence to a predicate device. The performance data presented refers to mechanical and biocompatibility testing of this physical device.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details relevant to AI/ML device performance based on the provided text.

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"Disposable needle for obtaining biopsies from Bone and Bone Marrow."

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I am sorry, but the provided text does not contain the information requested. The document is an FDA letter regarding the 510(k) clearance for a bone biopsy needle and includes sections on "Indications for Use." However, it does not detail any acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a more detailed submission summary. Therefore, I cannot generate the requested table or answer the specific questions about the study.

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