(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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.