Search Results

The Arthrex Small Fragment Plates and Screws are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies for Hallux Valgus.

The Arthrex Small Fragment Plate is an L-shaped opening wedge plate with four holes for insertion of screws for fixation. The plate is available in opening and closing wedge design, in various lengths, in both left and right configurations. The Arthrex screw is a cortical, headed, self-tapping screw available in one diameter, in numerous length options.

The provided document is a 510(k) summary for the Arthrex Small Fragment Plates and Screws, which are medical devices (implants). The information requested pertains to the evaluation of a software algorithm's performance, which is not relevant to this type of medical device submission.

Here's why the requested information cannot be provided from this document:

• Device Type: The Arthrex Small Fragment Plates and Screws are physical implants used for internal bone fixation. They are not a software algorithm, an AI model, or an diagnostic imaging device.
• Approval Process: A 510(k) for a device like this focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) based on material properties, design, manufacturing, and intended use. It does not involve studies to establish performance criteria like sensitivity, specificity, or reader studies in the way an AI/software device would.
• Missing Information: The concepts of "acceptance criteria for an algorithm," "test set," "ground truth," "expert adjudication," "MRMC study," "standalone performance," or "training set" simply do not apply to the regulatory evaluation of a bone plate and screw system.

Therefore, I cannot extract the requested information from this document because it is not applicable to the device described.

Ask a specific question about this device