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The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

The Level One (L1) Hand Plating System includes metallic plates, washers, and screws intended for small bone fixation. Plates are pre-contoured to accommodate patient anatomy, available in various shapes and range in thickness from 0.6mm - 3.0mm, and are compatible with the standard and multidirectional locking screws offered in the system. Screws are self-tapping, available in a standard or multidirectional locking configuration and range in diameter from 1.0mm - 2.7mm with lengths from 2mm - 32mm. Standard screws may be used alone or in conjunction with the washers or plates for small fragment osteosynthesis. Implants are manufactured from CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136). The system includes the necessary instrumentation to facilitate implantation. The purpose of this submission is to offer the previously cleared non-sterile device system in K141489 in sterile packaging via gamma irradiation.

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of device performance, as it is a 510(k) summary for a medical device (Level One Hand Plating System).

The primary purpose of this document is to demonstrate substantial equivalence to a predicate device, focusing on material, design, intended use, and a change in sterilization method (from non-sterile to sterile via gamma irradiation).

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this submission.

The document states:

• "Clinical testing was not necessary for the determination of substantial equivalence." This indicates that no clinical performance study, as might be required for new or high-risk devices, was performed or presented.
• The non-clinical performance data section focuses on biocompatibility and bacterial endotoxin testing to support the change to sterile packaging, rather than demonstrating performance against specific clinical or diagnostic acceptance criteria.

In summary, this document is concerned with regulatory approval based on equivalence, not with proving new performance claims against defined acceptance criteria.

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