(206 days)
The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:
-Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
-Opening wedge of Medial Cuneiform or Cotton osteotomies
-Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
-Metatarsal Cuneiform osteotomies
- -Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies(TMT or Lapidus) -Hindfoot osteotomies
These devices are intended to be used with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.
The Osteotomy Truss System is a titanium alloy implant used for correction of small bones in the foot. It is offered in three footprints and multiple sizes for each footprint with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4WEB truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.
The provided text is a 510(k) summary for a medical device (Osteotomy Truss System - OTS) and primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/algorithm performance.
Therefore, I cannot fulfill your request with the provided input text. The information requested (acceptance criteria, device performance, sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.) would be typical for a clinical study evaluating the performance of a diagnostic or AI-driven device, which is not what this 510(k) summary describes.
This document describes a submission for a metallic bone fixation appliance, and the "Non-clinical testing" section refers to mechanical and MRI compatibility tests (ASTM standards), not clinical performance or AI algorithm validation.
§ 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.