(56 days)
The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.
The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Ankle System is made of Pure Titanium and 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-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 cortical screws, locking screws diameter is 3.5mm lengths is from 10mm to 70mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc., The ARIX Ankle System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery.
This document describes a 510(k) premarket notification for the ARIX Ankle System, a device for internal fixation of the distal fibula. The submission aims to demonstrate substantial equivalence to a predicate device, the VariAX™ Distal Fibula Plate (K081284).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly define "acceptance criteria" with specific numerical targets in the same way a clinical trial might for a diagnostic device. Instead, the performance is reported against established ASTM standards for metallic bone plates and screws. The "acceptance criteria" are implied to be conformance with these standards and equivalency to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Plates | |
| Conformance to ASTM F382-99: Standard Specification and Test Method for Metallic Bone Plates | Dimension test: Complied with design specifications. |
| Single Cycle Bending test: Demonstrated compliance with ASTM F382. | |
| Bending Fatigue test: Demonstrated compliance with ASTM F382. | |
| Screws | |
| Conformance to ASTM F543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws | Dimension test: Complied with design specifications. |
| Driving torque test: Demonstrated compliance with ASTM F543-07. | |
| Axial pull-out test: Demonstrated compliance with ASTM F543-07. | |
| Torsion test: Demonstrated compliance with ASTM F543-07. | |
| Substantial equivalence to predicate device (K081284) in design, function, materials, and operational principles. | The test results indicate that the ARIX Ankle System is equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify the sample size used for the bench tests. It mentions "plates" and "screws" in general, implying a set of each type was tested, but no numbers are provided.
- Data provenance: The data provenance is from non-clinical bench testing conducted to verify that the proposed device met design specifications and complied with ASTM standards. There is no information regarding country of origin for the test data, nor is it retrospective or prospective in the clinical sense, as no human data was involved.
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 the study was non-clinical bench testing. Ground truth in this context would be defined by the specifications of the ASTM standards and the design specifications of the device, not expert consensus.
4. Adjudication method for the test set:
This information is not applicable as the study was non-clinical bench testing. Performance was assessed against objective engineering standards and specifications.
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. The device is a physical bone fixation system, not an AI or imaging diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used:
The ground truth used for the non-clinical tests was based on:
- ASTM Standards: Specifically, ASTM F 382-99 for metallic bone plates and ASTM F 543-07 for metallic medical bone screws.
- Design Specifications: The device was tested to verify it met its "design specifications."
- Predicate Device Characteristics: The performance and characteristics were compared to the predicate device to establish substantial equivalence.
8. The sample size for the training set:
This information is not applicable. There was no "training set" in the context of an AI/machine learning model, as this is a physical medical device.
9. How the ground truth for the training set was established:
This information is not applicable. There was no training set or ground truth in the AI/machine learning sense.
§ 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.