(170 days)
The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalcaneal and tibiotalar joints.
The ARIX Ankle Distal Tibia System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes.
The ARIX Ankle Distal Tibia System is made of Titanium Alloy (Ti-6AI-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.
This document is a 510(k) Premarket Notification for the ARIX Ankle Distal Tibia System. It states that no clinical studies were considered necessary and performed. Therefore, a study demonstrating the device meets acceptance criteria, an MRMC comparative effectiveness study, or a standalone algorithm-only study were not conducted or reported in this document.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
Since no clinical study was performed, there are no reported acceptance criteria or device performance measurements in terms of clinical outcomes or diagnostic accuracy. The testing performed focused on compliance with material and mechanical standards.
| Acceptance Criteria (from standards) | Reported Device Performance (from bench tests) |
|---|---|
| Compliance with ASTM F382 (Metallic Bone Plates) Standard | The subject device complies with ASTM F382. |
| Compliance with ASTM F543 (Metallic Medical Bone Screws) Standard | The subject device complies with ASTM F543. |
| Biocompatibility (Ti-6AL-4V) | ARIX Ankle Distal Tibia System is made of Titanium Alloy (Ti-6AI-4V), meeting ASTM F136 for biocompatibility, similar to predicate devices. |
| No significant differences in technological characteristics compared to predicate devices that would adversely affect use. | No significant differences found in design features, material, surface treatment, sterilization methods, biocompatibility, and performance compared to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical test set was used. The testing was non-clinical bench testing of the physical device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set or ground truth established by medical experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device is a physical bone fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. The device is a physical bone fixation system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical ground truth was established for this device, which is a physical implant. The "ground truth" for the non-clinical testing was compliance with established ASTM standards for material properties and mechanical performance.
8. The sample size for the training set
Not applicable, as no training set was used. The device is a physical bone fixation system, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as no training set or its ground truth was established.
§ 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.