(176 days)
The ARIX Ankle Distal Tibia System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal tibia including distal tibia fractures in combination with diaphyseal fracture.
The ARIX Ankle Distal Tibia System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The plates are Medial Type and Anterolateral Type and T Type. The screws are Cortical Screw (28-SO-L Series, 35-SO-L Series) and Locking Screw (28L-SO-L Series, 35L-SO-L Series). The system is made of ASTM F 136, 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 2.8 mm to 3.5 mm and lengths from 8 mm to 80 mm. The system is provided as Gold color which is casted according to the anodizing technique while apply 5 V electric energy to the titanium. It also includes various manual surgical instruments, such as drill bits, counter sink, depth gauge, compression, drill guide, drill sleeve, guide pin, bender and screw driver handle. The ARIX Ankle Distal Tibia System is not provided sterile.
This document, K170313, describes the ARIX Ankle Distal Tibia System, a bone plate and screw system intended for fixation of intra- and extra-articular fractures and osteotomies of the distal tibia.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Standard) | Reported Device Performance (Reference) |
|---|---|
| Plates: |
- Bending strength test per ASTM F382-14
- Bending fatigue test per ASTM F382-14 | The test results for bending strength and bending fatigue for the ARIX Ankle Distal Tibia System indicate equivalence to the predicate device. (Page 6) |
| Screws: - Driving torque test per ASTM F543-13
- Torsion test per ASTM F543-13
- Axial pull out test per ASTM F543-13 | The test results for driving torque, torsion, and axial pull out for the ARIX Ankle Distal Tibia System indicate equivalence to the predicate device. (Page 6) |
| Biocompatibility: Meet ASTM F136 for Titanium Alloy (Ti-6Al-4V) | Device material (ASTM F 136, Titanium Alloy) is widely used for surgical implants with well-known biocompatibility. (Page 5) |
| Sterilization: Achieve a SAL of 10^-6 via autoclave, validated per ISO 17665-1: 2006 | Sterilization method validated per ISO 17665-1: 2006. (Page 5) |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for specific tests. The document refers to "bench tests" performed using the "proposed device" and "predicate device." It doesn't specify the number of plates or screws tested for each mechanical test.
- Data Provenance: The study is a non-clinical bench test conducted to verify design specifications and compliance with ASTM standards. The provenance is internal testing performed by the manufacturer or a contracted lab. There is no mention of country of origin for the data itself, but the manufacturer is Jeil Medical Corporation in Korea. This is a retrospective analysis in the sense that the testing was performed to support the 510(k) submission, not as a prospective clinical trial.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This submission is for a medical device (bone fixation system) and relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device, not on diagnostic accuracy against a clinical ground truth established by experts.
4. Adjudication Method
- Not Applicable. As no expert review or clinical diagnosis is involved in the acceptance criteria, there is no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "No clinical studies were considered necessary and performed." This means no MRMC study was conducted.
6. Standalone Performance Study
- Yes, a form of standalone performance was done for the device itself. The bench tests (bending strength, fatigue, driving torque, torsion, axial pull-out) assess the mechanical performance of the ARIX Ankle Distal Tibia System independently, comparing it to established standards and a predicate device. This is "standalone" in the sense that the mechanical behavior of the device components is evaluated without human interaction during the test, beyond setting up the experiment.
7. Type of Ground Truth Used
- Standardized Mechanical Performance Metrics / Predicate Device Performance. The "ground truth" for the acceptance criteria and performance evaluation is based on:
- Compliance with recognized international standards (ASTM F382-14 for plates, ASTM F543-13 for screws).
- Demonstration of equivalent mechanical performance to a legally marketed predicate device (Synthes LCP Distal Tibia Plates - K013248).
8. Sample Size for Training Set
- Not Applicable. This is a medical device (bone fixation system) and not an AI/ML diagnostic algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing process are informed by established engineering principles and material science, not by training on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, there is no ground truth established for it.
§ 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.