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510(k) Data Aggregation
(469 days)
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 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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(43 days)
The Smart Toe II is indicated for interphalangeal fusion of the toes.
The X Fuse is indicated for interphalangeal fusion of fingers and toes.
The Smart Toe II & X Fuse, previously cleared in K112179, are threaded metallic bone fixation fasteners and include superelastic and body temperature activated shape memory Nitinol per ASTM F2063-18. The subject of the bundled submission introduces a new passivation step and packaging change.
I am sorry. The provided FDA submission document is a 510(k) summary for a medical device (Smart Toe II & X Fuse) and primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing. It explicitly states that clinical testing was not required for this submission.
Therefore, I cannot provide information on acceptance criteria, reported device performance from a clinical study, sample sizes for test sets (as there was no clinical test set), expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The document describes non-clinical testing for mechanical performance and corrosion testing. The acceptance criteria for these non-clinical tests would typically be a demonstration of equivalence or superiority to the predicate device, but these specific criteria and numerical results are not detailed in the provided summary.
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