(197 days)
The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.
The ARIX Wrist System consists of plates designed for the Ulna and Radius. The ARIX Wrist 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-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 vary essentially through different lengths and diameters. The screws in this system are available from 2.0mm to 2.8mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and hand body. The ARIX Wrist System not provided sterile. It is required to be sterilized via autoclave using the validated method prior to surgery.
The provided text is a 510(k) Summary for the ARIX Wrist System. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria in the context of an AI/algorithm-based medical device.
Therefore, the information required for the requested table and study details (acceptance criteria, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not present in the provided text.
The text describes bench tests conducted, but these are for mechanical properties of the device components (plates and screws) against ASTM standards, not for evaluating an algorithmic performance.
Here's a breakdown of what is available from the text, and what is missing:
What is present (related to traditional device testing):
- Bench Tests: The document lists several bench tests performed on the plates and screws, primarily against ASTM standards (ASTM F 382 for plates, ASTM F 543 for screws). These tests assess mechanical properties like dimensions, bending, fatigue, driving torque, axial pull-out, and torsion.
- Conclusion on Equivalence: The document concludes that the ARIX Wrist System is substantially equivalent to predicate devices based on these bench tests and shared characteristics.
- No Clinical Studies: The document explicitly states: "No clinical studies were considered necessary and performed." This means there would be no human reader studies or direct human performance data in this submission.
What is missing (which would be relevant for an AI/algorithm device study):
- Table of Acceptance Criteria and Reported Device Performance (for an algorithm): No such table is provided, as this is not an algorithm's performance being evaluated. The bench tests indicate compliance with mechanical standards, but not a specific performance metric like sensitivity or specificity.
- Sample sizes used for the test set and data provenance: Not applicable, as there is no "test set" of data for algorithmic evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No such study was done or reported.
- If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In essence, the provided document is a regulatory submission for a physical medical device (bone fixation system), not a software or AI-driven device requiring performance evaluation against diagnostic or predictive metrics. Therefore, the requested information pertaining to acceptance criteria and studies for an algorithm's performance is not contained within this text.
§ 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.