(30 days)
The APTUS® Titanium Fixation System is indicated for use in hand and forearm fractures and arthrodeses.
APTUS® Hand group:
- · Management of the fractures of the distal, middle and proximal phalanges and metacarpals
- · Management of all types of transversal fractures, spiral fractures near joints with or without joint
- involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
- · DIP and PIP arthrodeses
- APTUS® Radius 2.5 group:
- · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
- Management via dorsal approach of ractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
APTUS® 2.0/2.3 Four Corner Fusion Plate
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.
APTUS® K-Wire System
The APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as guide pins for insertion of other implants.
APTUS® 1.5 TriLock
The APTUS® 1.5 TriLock is indicated for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS® Hand group:
- · Management of the fractures of the distal, middle and proximal phalanges and metacarpals
- · Management of all types of transversal fractures, fractures near joints with or without joint
- involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
- DIP and PIP arthrodeses
- APTUS® Radius 2.5 group:
- · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
- Management via dorsal approach of ractures that cannot be adequately reduced via volar approach.
procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
APTUS® Ulna Plates
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
APTUS® Wrist 2.5 System
APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures and arthrodeses.
APTUS® Wrist Arthrodesis Plates APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
APTUS® Forearm Shaft Plates
APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.
The Sterile Products of the APTUS System is a plating, screw, and K-wire system for internal fixation of the hand, wrist, and/ or forearm. All plates have anatomical designs that are appropriate to their intended use. The subject device plates includes crew holes designed to accommodate appropriately sized bone screws.
Sterile Products of the APTUS System plate, screw, and K-wire system are the previously cleared predicate and additional predicate devices. The overal dimens of the subject device plates have the same lengths, widths, and thicknesses as the previously cleared predicate and additional predicate device screws have the same design as the previously cleared Medartis APTUS Screws under K051567, K103332, and K142906. These include both locking (cortical) screws. The subject device K-wires have design as the previously cleared APTUS K-Wires System under K092038. The K-wires are provided with a diameter of 1.2, 1.6, or 1.8 mm. All have a length of 150 mm. Single-ended trocar points are provided in 1.2 mm and 1.6 mm diameters, and single-ended bayonet (lancet) points are provided at all 3 diameters.
This submission includes all plates screws, and K-wires that have been previously cleared under the predicate devices by Medartis AG, however, they will be provided in a sterile condition.
All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.
All subject device screws are manufactured from titanium alloy conforming to ASTM F136.
All subject device K-wires are manufactured from stainless steel conforming to ASTM F138.
All subject devices are associated with the predicate device and/or an additional predicate device mentioned in the predicates and product list sections.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device called "Sterile Products of the APTUS System." It describes the device, its intended use, a comparison to previously cleared predicate devices, and a summary of non-clinical testing.
However, this document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The product is a bone fixation system (plates, screws, and K-wires), and the 510(k) submission is primarily focused on demonstrating substantial equivalence to already marketed devices, especially regarding the sterilization process and packaging of these physical implants.
The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are highly relevant to the validation of AI/ML-enabled medical devices that perform tasks like image analysis, diagnosis, or prediction. This document describes a physical implantable device, not an AI/ML algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them in the context of AI/ML, as this information is not present in the provided text. The document is about hardware (bone fixation systems) and its sterilization, not software or AI performance 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.