AxSOS 3 Ti

• K Number: K172350
• Device Name: AxSOS 3 Ti
• Manufacturer: Stryker GmbH
• Date Cleared: 2017-12-15 ( 134 days)
• Product Code: HRS , HWC
• Regulation Number: 888.3030
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K133451 , K000080

Intended Use

AxSOS 3 Ti is intended for long bone fracture fixation

Indications include:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions and malunions
• Normal and osteopenic bone
• Osteotomies
• Periprosthetic fractures of the femur and proximal tibia.

The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:

• Periprosthetic fractures
• Diaphyseal and metaphyseal areas of long bones in pediatric patients

The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis

Device Description

The AxSOS 3 Ti system (also referred to as the AxSOS 3 Ti Locking Plate system) is a system used for internal fixation applications. The system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws (limited to waisted compression plates) . The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirschner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components are available sterile and non-sterile and are manufactured from titanium alloy (Ti6Al4V-ELI) per ASTM F136.

The AxSOS 3 Ti 5.0mm Cable Plug is categorized as permanent, direct bone/tissue patient contacting implant with contact duration >30 days. It is manufactured from titanium alloy (ASTM F136, Ti6Al4V-ELI) and is Type II anodized. It is designed to be used in combination with the 5.0mm AxSOS 3 Ti system. It is an aid for internal fixation component used in conjunction with the AxSOS 3 Ti 5.0mm distal lateral femur, broad compression and narrow compression plates. The Cable Plug is threaded or clicked into a 5.0mm universal locking hole of the AxSOS 3 Ti plates and provides a positioning point for a cerclage cable.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device (AxSOS 3 Ti) and focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria through AI/ML performance.

The document discusses:

• Device Name: AxSOS 3 Ti
• Regulation Number and Name: 21 CFR 888.3030 (Single/Multiple Component Metallic Bone Fixation Appliances And Accessories) and 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
• Regulatory Class: Class II
• Product Code: HRS, HWC
• Indications for Use: Long bone fracture fixation, including various types of fractures, non-unions, malunions, normal and osteopenic bone, osteotomies, and periprosthetic fractures. Also specific indications for Waisted Compression Plates in pediatric patients and for the scapula and pelvis.
• Predicate Devices: AxSOS 3 Ti (K153379 & K162439) and Dall-Miles Homogenous Vitallium Cable (K961283).
• Reference Devices: Fixos Screw System (K133451) and Asnis III Cannulated Screw System (K000080).
• Non-Clinical Testing: Performed to ASTM standards for pull-out, dynamic compression, and MR compatibility (magnetically induced displacement force, torque, heating, and image artifacts).
• Clinical Testing: Not required for this submission.

Therefore, we cannot answer your request based on the provided text because it does not contain information about:

• Acceptance criteria and reported device performance related to AI/ML. The device is a bone fixation system, not an AI/ML-driven diagnostic or therapeutic device.
• Sample size for a test set (in the context of AI/ML).
• Data provenance (country of origin, retrospective/prospective) for AI/ML data.
• Number of experts and their qualifications for establishing ground truth for AI/ML.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI/ML.
• Standalone (algorithm only) performance for AI/ML.
• Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established (for AI/ML).

The document is a regulatory approval letter for a conventional medical device based on engineering and materials testing, not an AI/ML performance study.

Regulation Number and Section

§ 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.