(89 days)
The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.
The Arthrex VAL Screws (3.5 mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.
The Arthrex VAL KreuLock™ Compression Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking screws that are offered in standard and reinforced configurations. They are offered with a 3.5 mm diameter and the standard versions range in lengths from 10 mm to 90 mm while the reinforced versions range in lengths from 10 mm to 110 mm. The reinforced configurations have a larger minor diameter with the same major diameter as the standard configurations.
The Arthrex VAL Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking screws that are offered in standard and reinforced configurations. They are offered with a 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The reinforced configurations have a larger minor diameter with the same major diameter as the standard configurations.
The provided text describes the 510(k) summary for the Arthrex VAL and VAL KreuLock™ Compression Screw System. This document outlines the device's technical specifications, indications for use, and a comparison to predicate devices, primarily focusing on demonstrating substantial equivalence through various mechanical and material tests.
However, there is no information within this document that describes a study involving an "AI device" or "algorithm." The document pertains to a medical device for bone fixation (screws), not a diagnostic or AI-powered imaging/analysis tool. Therefore, it does not contain the details typically sought when asking about acceptance criteria and study designs for AI/algorithmic devices, such as:
- A table of acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, etc.)
- Sample sizes for test sets of AI data
- Data provenance for AI training/test sets
- Number of experts for ground truth establishment for AI
- Adjudication methods for AI ground truth
- Multi-reader multi-case (MRMC) studies for AI assistance
- Standalone performance of an AI algorithm
- Type of ground truth used for AI models
- Sample size and ground truth establishment for AI training sets
To directly answer your request based on the provided text, the answer is that the given document does not contain the information you are asking for, as it is not about an AI/algorithmic device.
The "Performance Data" section of the document describes the following types of tests for the mechanical bone screws:
- Mechanical Testing:
- Pullout testing
- Cantilever testing
- Pushout testing
- Head locking testing
- Compression testing
- Torque testing
- Axial pullout analysis
- Torsional strength testing
- Driving torque testing
- These tests were conducted in accordance with ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws to demonstrate that the changes do not affect performance and that the proposed devices are substantially equivalent to the primary predicate device.
- MRI Compatibility Testing:
- MRI force, torque, and image artifact testing were conducted in accordance with
- FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment"
- ASTM F2052 (Measurement of Magnetically Induced Displacement Force)
- ASTM F2119 (Evaluation of MR Image Artifacts from Passive Implants)
- ASTM F2182 (Measurement of Radio Frequency Induced Heating near Passive Implants)
- ASTM F2213 (Measurement of Magnetically Induced Torque on Medical Devices)
- MRI force, torque, and image artifact testing were conducted in accordance with
The acceptance criteria for these mechanical tests would typically be defined by the relevant ASTM standards and comparative data against the predicate device to demonstrate equivalent or superior performance in the specified mechanical properties. The study "proves" the device meets these criteria by showing that the results of these tests fall within acceptable ranges as compared to the predicate device.
To reiterate, if you're looking for information specific to AI/algorithmic device acceptance criteria and study designs, this document does not provide it because the device described is a physical bone screw system.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.