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The Arthrex VAL KreuLock™ Compression Screws (2.0-3.0 mm 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, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, clavicle and scapula. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.

The Arthrex Hybrid 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, 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 Hybrid Low Profile VAL Screws (3.5mm 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, 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 and VAL KreuLock™ Compression Screw System is a fracture fixation device system comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking (VAL) screws that are offered in standard and hybrid configurations. The Arthrex VAL KreuLock™ Compression Screws are offered in 2.0, 2.7 and 3.0 diameters and range in lengths from 6 mm to 80 mm. The Arthrex Hybrid KreuLock™ Compression Screws and Hybrid Low Profile VAL Screws consist of line extension screws with the locking head geometry of the existing 2.7 mm screws and a shaft geometry of the existing 3.5 mm screws. The Arthrex Hybrid KreuLock™ Compression Screws range in lengths from 12 mm to 80 mm and the Arthrex Hybrid Low Profile VAL Screws range in lengths from 10 mm to 80 mm. Arthrex VAL and VAL KreuLock™ Compression Screw System consist of single-use, non-sterile devices intended for end-user sterilization.

The provided text describes a 510(k) premarket notification for the Arthrex VAL and VAL KreuLock™ Compression Screw System. This is a medical device submission, and the information is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI/ML algorithm's performance study with acceptance criteria and ground truth.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for an AI/ML model, are not applicable to this document.

However, I can extract information related to the performance data and the conclusion regarding substantial equivalence.

Here's a summary of the available information:

1. A table of acceptance criteria and the reported device performance:

Since this is a mechanical fixation device, the "acceptance criteria" are not framed in terms of metrics like sensitivity or specificity, but rather in terms of compliance with established ASTM standards for mechanical properties. The reported performance is that the device meets these standards.

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated in terms of the number of screws or test repetitions. Testing was conducted "on the proposed Arthrex VAL and VAL KreuLock™ Compression Screw Systems."
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from mechanical and MRI compatibility testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic system requiring expert interpretation for ground truth. The "ground truth" is adherence to established engineering and safety standards.

4. Adjudication method for the test set:

• Not Applicable. Mechanical testing to standards does not typically involve adjudication in the clinical sense. Results are measured against predefined engineering 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:

• Not Applicable. This is a medical implant, not an AI/ML diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is adherence to recognized ASTM International standards and FDA guidance documents for mechanical properties (e.g., pull-out strength, torsional strength, driving torque) and MRI compatibility (e.g., force, torque, image artifact, heating).

8. The sample size for the training set:

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

9. How the ground truth for the training set was established:

• Not Applicable. This is a medical implant, not an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance letter for a traditional medical device (bone screws), not an AI/ML software device. Therefore, most of the requested information pertinent to AI/ML model validation is not found here and is not relevant to this type of device submission. The study described focuses on demonstrating the physical and mechanical properties of the screws meet established industry standards and are substantially equivalent to predicate devices.

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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)

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.

Ask a specific question about this device