(111 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 is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Wrist System is made of Unalloyed Titanium Alloy (Ti-6AI-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 screws are selftapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 1.5mm and 2.5mm. The Non-locking Screws are provided with diameter 2.5mm. The Smooth Peg Screws are provided with diameter 2.0mm. And Locking Screws are provided with lengths from 4mm to 56mm. Non-locking Screws are provided with lengths from 6mm to 56mm and Smooth Peg Screws are provided with lengths from 10mm to 30mm.
The provided text is a 510(k) summary for the ARIX Wrist System, a medical device for bone fixation. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on non-clinical (bench) testing.
However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device. The ARIX Wrist System is a physical metallic bone fixation appliance, and its clearance relies on demonstrating substantial equivalence to similar predicate devices through bench testing of mechanical properties and biocompatibility, not through clinical or standalone performance studies of an AI algorithm.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance: This document does not describe performance metrics or acceptance criteria for an AI/ML device. It focuses on the physical properties and mechanical performance of a metallic implant.
- Sample size for the test set and data provenance: No test set of clinical images or data is mentioned for an AI/ML study. The "test set" refers to the physical devices undergoing bench tests (e.g., plates and screws).
- Number of experts and qualifications for ground truth: No expert annotation or ground truth establishment relevant to AI/ML is mentioned.
- Adjudication method: Not applicable to a physical implant.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device.
- Standalone performance (algorithm only): Not applicable, as there is no algorithm.
- Type of ground truth used: Not applicable in the context of AI/ML ground truth. The "ground truth" for this device would be its physical and mechanical properties, assessed through standardized bench tests.
- Sample size for the training set: Not applicable, as there is no AI model requiring a training set.
- How ground truth for the training set was established: Not applicable.
The document states:
- "Bench tests were conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with the following standards: ASTM F382, Standard Specification and Test Method for Metallic Bone Plates; ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws."
- "The following tests were performed with the predicate device: Plate (4-Point Bending Test, 4-Point Fatigue Test), Screw (Driving Torque Test, Torsion Test, Axial Pull-out Test), Smooth Peg Screw (3-Point Bending Test)."
- "The results of this testing indicate that the ARIX Wrist System is equivalent to predicate device."
- "No clinical studies were considered necessary and performed."
This clearly indicates that the clearance was based on non-clinical bench testing comparing the physical device's mechanical performance to established standards and predicate devices, not on a study involving AI/ML and human clinical data.
§ 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.