(137 days)
The ARIX Sternal System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion.
The ARIX Sternal System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Sternal System is made of Unalloyed Titanium Alloy (Ti-6Al-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 2.4, 2.7mm. And both are provided with lengths from 8 mm to 20 mm.
The provided document is a 510(k) summary for the ARIX Sternal System, a medical device. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through novel acceptance criteria and studies.
Therefore, the document does not contain information related to acceptance criteria for an AI/algorithm's performance, nor does it describe a study to prove such performance against specific metrics.
The document details the following regarding the device:
- Device Name: ARIX Sternal System
- Intended Use: Stabilization and fixation of fractures of the anterior chest wall following sternotomy and sternal reconstructive surgical procedures, to promote fusion.
- Materials: Unalloyed Titanium Alloy (Ti-6Al-4V)
- Predicate Device: K110574 - SternaLock Blu Biomet Microfixation Sternal Closure System and additional similar predicate devices.
- Non-Clinical Testing: Bench tests were conducted to verify that the subject device met all design specifications and complies with ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates) and ASTM F543 (Standard Specification and Test Method for Metallic Medical Bone Screws).
- Tests performed on Plate: 4-Point Bending Test, 4-Point Fatigue Test.
- Tests performed on Screw: Driving Torque Test, Torsion Test, Axial Pull-out Test.
- Conclusion: The results indicated that the ARIX Sternal System is equivalent to the predicate device.
- Clinical Testing: "No clinical studies were considered necessary and performed." This means there is no data on human or AI reader performance available in this document.
In summary, none of the requested information regarding acceptance criteria for AI/algorithm performance, study methodologies, sample sizes for AI training/test sets, expert ground truth establishment, or MRMC studies is present in this 510(k) summary. This document is for a physical medical device (sternal system), not an AI/algorithm-based diagnostic or therapeutic device.
§ 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.