(30 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 ARIX Ankle Distal Tibia System is made of Titanium Alloy (Ti-6Al-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-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 Screws are provided with diameter 3.5mm and 4.0mm. And Screws are provided with lengths from 10mm to 110mm.
The provided document is a 510(k) summary for the "ARIX Ankle Distal Tibia System," a device intended for bone fixation. However, it explicitly states, "No clinical studies were considered necessary and performed." Therefore, there is no information available within this document regarding acceptance criteria or a study proving the device meets those criteria, as no clinical study was conducted.
The document focuses on demonstrating substantial equivalence to a predicate device (K170313) through bench tests and technological characteristics comparison. The bench tests conducted verified the device met design specifications and complied with ASTM standards for metallic bone plates and screws.
Here's a breakdown of what can be extracted from the document, acknowledging the absence of clinical study data:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study was performed, there are no reported clinical performance criteria or results. The document mentions bench test results indicating compliance with ASTM standards, these would act as performance criteria for mechanical characteristics.
| Acceptance Criteria (from Bench Tests) | Reported Device Performance |
|---|---|
| Compliance with ASTM F382 (Metallic Bone Plates) | Complies |
| Compliance with ASTM F543 (Metallic Medical Bone Screws) | Complies |
| 4-Point Bending Test (Plate) | Results indicate equivalence to predicate device |
| 4-Point Fatigue Test (Plate) | Results indicate equivalence to predicate device |
| Driving Torque Test (Screw) | Results indicate equivalence to predicate device |
| Torsion Test (Screw) | Results indicate equivalence to predicate device |
| Axial Pull-out Test (Screw) | Results indicate equivalence to predicate device |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for the bench tests.
- Data Provenance: The bench tests were conducted internally by the manufacturer ("Non-Clinical Test Summary"). The geographical origin is therefore Korea, South (location of Jeil Medical Corporation). The data is by definition prospective (designed and executed for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as no clinical study was performed. The "ground truth" for the non-clinical bench tests is established by the ASTM standards and mechanical engineering principles.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as no clinical study was performed. Adjudication methods are typically used in clinical trials to resolve discrepancies in expert evaluations.
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:
This information is not applicable as no clinical study was performed and this device is a physical bone fixation system, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used:
- For the bench tests, the "ground truth" is defined by the ASTM standards (ASTM F382, ASTM F543), which set the criteria for mechanical properties, and the performance of the predicate device (K170313), against which the subject device's performance was compared for equivalence.
8. The sample size for the training set:
This information is not applicable as no clinical study was performed. A "training set" typically refers to data used to train machine learning models or for initial clinical observations, neither of which are mentioned here.
9. How the ground truth for the training set was established:
This information is not applicable as no clinical study was performed and therefore no training set.
§ 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.