(84 days)
The ARIX Diaphysis System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The ARIX Diaphysis System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Diaphysis System is made of Unalloyed Titanium and Titanium Alloy (Ti-6Al-4V). The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping, which are applied with the reconstruction locking screws together. The Cortical Screws & locking screws are provided with diameter 3.5 mm and lengths from 10 mm to 100 mm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates) | Device demonstrated compliance through 4-Point Bending Test and 4-Point Fatigue Test. |
| Compliance with ASTM F543 (Standard Specification and Test Method for Metallic Medical Bone Screws) | Device demonstrated compliance through an engineering analysis evaluating torsional strength and pull-out strength. |
| Equivalence to predicate devices in design, function, materials, and operational principles as internal fixation components. | Non-clinical bench tests confirmed the ARIX Diaphysis System is equivalent to predicate devices, particularly in mechanical properties. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical bench testing. Therefore, there are no human subject test sets or associated data provenance (e.g., country of origin, retrospective/prospective). The "test set" in this context refers to the physical devices (plates and screws) subjected to mechanical testing. The sample size for these tests is not explicitly stated in numerical terms (e.g., "n=X plates," "n=Y screws"), but the phrase "The following tests were performed with the predicate device" implies a comparison between the subject device and the predicate device for each test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a non-clinical bench study. The "ground truth" for mechanical testing is established by the ASTM standards and the measured physical properties of the devices. No human experts were used to "establish ground truth" in the way they would for medical image interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As a non-clinical bench study, there was no adjudication method involving multiple experts or consensus for the "test set" in the context of human data. The compliance was determined by objective measurements against established engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were considered necessary and performed." This study is a non-clinical bench study focused on mechanical performance and equivalence to predicate devices, not a clinical trial involving human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device (bone fixation system), not an algorithm or AI software. Therefore, there is no "standalone algorithm only performance" to assess.
7. Type of Ground Truth Used
The "ground truth" for this study was engineering standards and mechanical test results. Specifically:
- ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates)
- ASTM F543 (Standard Specification and Test Method for Metallic Medical Bone Screws)
- Comparative mechanical properties (e.g., torsional strength, pull-out strength, bending, fatigue) relative to legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. This is a medical device and not an AI or machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical 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.