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The EasyClip@ staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).
The EasyClip® Xpress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).

The EasyClip® & EasyClip® Xpress, previously cleared in K122113 and K162321, includes superelastic bone staples shape memory Nitinol per ASTM F2063-18. The subject of the bundled submission introduces a contraindication for both systems and packaging change for EasyClip.

The provided text describes a 510(k) premarket notification for the EasyClip® and EasyClip® Xpress bone fixation staples. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with detailed acceptance criteria and performance data for a new device.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method), MRMC studies, standalone performance, ground truth types, and training set information is not available in the provided text.

The document states:

• "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
• "All bench tests performed in accordance with ASTM standards and previously presented in EasyClip® and EasyClip® Xpress. K122113 and K162321, respectively, remains true and accurate."

This indicates that a new clinical study or detailed performance study using specific acceptance criteria for the current submission was not performed. Instead, the submission relies on the performance data from the predicate devices (K122113 and K162321) and demonstrates that the modifications (a new contraindication and minor packaging change for EasyClip) do not alter the fundamental scientific technology or raise new questions of safety and effectiveness.

The non-clinical performance data mentioned refers to packaging, biocompatibility, and corrosion tests to ISO and ASTM standards, but these are general safety and materials compliance tests, not a performance study to assess a specific functional acceptance criterion of the device's clinical efficacy.

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