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The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex® HV bone cement.

The SpineJack Expansion Kit (herein referred to as “SpineJack”) is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and a validated Stryker PMMA bone cement, such as Stryker VertaPlex® or VertaPlex® HV Bone Cement, is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack but are sold separately.

This document is a 510(k) premarket notification decision letter from the FDA regarding the SpineJack® Expansion Kit. It primarily addresses changes to the device's contraindications, specifically the removal of Type A trauma fractures, rather than providing detailed acceptance criteria and performance data for a new device or a device involving AI.

Therefore, the information required to answer your request about acceptance criteria and study proving device meets acceptance criteria (especially for an AI/software device) is NOT present in the provided text. The document explicitly states:

• Non-Clinical Testing: "Non-clinical testing was deemed not required for this 510(k). The SpineJack implant was previously tested to be non-pyrogenic."
• Clinical Testing: "Clinical testing was deemed not required for this 510(k)"
• Other Evidence: "Clinical literature, post-market surveillance data and a risk analysis per ISO 14971 were used in support of the subject modification."

This indicates that the submission is for a modification to an existing device (SpineJack Predicate Device, K181262), and the FDA determined that no new testing (clinical or non-clinical) was needed to establish substantial equivalence for the change (removal of Type A trauma fractures from contraindications). Instead, the decision was based on existing clinical literature, post-market data, and risk analysis.

Consequently, I cannot fill out the requested table or answer the specific questions about acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone performance, as this kind of data is not provided in the document. The document is a regulatory approval letter for a device modification, not a study report.

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