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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 Mini Comprehensive Fixation System (1.0 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand and wrist.

The Arthrex Mini Comprehensive Fixation System - 1.0mm Screws are manufactured from titanium. The screws are headed and self-tapping. The screws are available as fully threaded, solid screws. The screws are 1.0mm in diameter and from 6 mm to 14 mm in length (in 1 mm increments). The screws are sold non-sterile and single-use.

The provided text describes the Arthrex Mini Comprehensive Fixation System - 1.0mm Screws. This is a medical device, specifically a bone fixation fastener, and the document outlines its regulatory submission to the FDA. The information focuses on its substantial equivalence to predicate devices and mechanical testing, not on AI/algorithm performance. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them, based on what is described:

1. Table of acceptance criteria and the reported device performance

• Statistically equivalent pull-out strength to predicate device (K030310).
• Statistically equivalent torque strength to predicate device (K030310).
• Acceptable Insertion Torque/Failure Torque values. | - Pull-out and torque testing conducted in accordance with ASTM F543 demonstrated that the proposed Arthrex Mini Comprehensive Fixation System – 1.0mm Screws perform statistically equivalent to the predicate device, K030310.
• An engineering analysis concluded that the Insertion Torque/Failure Torque values of the Arthrex Mini Comprehensive Fixation System – 1.0mm Screws were acceptable.
• The submitted mechanical testing data demonstrates that the pull-out and torque strength are substantially equivalent. |
  | MR Compatibility (for MR Conditional labeling):
• Safe in the Magnetic Resonance (MR) Environment, including acceptable:
  • Magnetically induced displacement force.
  • MR image artifacts.
  • Radio frequency induced heating.
  • Magnetically induced torque. | - MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance and ASTM standards (F2052, F2119, F2182, F2213).
• The MR compatibility testing supports the device's MR Conditional labeling. There is no increased risk from this difference in technology. |
  | Device Material:
  Manufactured from titanium alloy identical to previously cleared devices (K191326 and K191344). | - The titanium alloy used is identical to the titanium alloy cleared in K191326 and K191344. |

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed under "Performance Data" in the 510(k) Summary.

• Mechanical Testing:

  • Test Performed: Pull-out and torque testing. An engineering analysis was also performed for insertion/failure torque.
  • Standard: Conducted in accordance with ASTM F543.
  • Conclusion: The tests demonstrated statistical equivalence to the predicate device (K030310) for pull-out and torque strength, and acceptable insertion/failure torque values.

• MR Compatibility Testing:

  • Test Performed: MRI force, torque, and image artifact testing. This included assessment of magnetically induced displacement force, MR image artifacts, radio frequency induced heating, and magnetically induced torque.
  • Standard: Conducted in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and specific ASTM standards:
    • 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)
    • ASTM F2213 (Measurement of Magnetically Induced Torque)
  • Conclusion: The testing supports the device's MR Conditional labeling, concluding no increased risk from this technology difference.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (e.g., number of screws or test replicates) for the mechanical or MR compatibility testing. It mentions "pull-out and torque testing was conducted" and "MRI force, torque, and image artifact testing were conducted," implying laboratory-based testing rather than clinical data from human subjects. The provenance is internal to the manufacturer (Arthrex Inc.). This type of testing is generally prospective in nature, as it is specifically designed and executed to evaluate the new device against established benchmarks and standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical bone fixation screw, and the evaluation involves engineering and laboratory testing conforming to ASTM standards and FDA guidance for physical properties and MR compatibility, not the assessment of images or clinical outcomes by medical experts for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this involves laboratory and engineering testing, not human expert adjudication of a test set.

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 document pertains to a physical medical device (bone screw), not an AI/software medical device involving human readers or comparative effectiveness studies with AI assistance.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" or reference for performance is the predicate device (K030310) performance in terms of pull-out and torque strength, as well as established engineering acceptability criteria for insertion/failure torque. For MR compatibility, the "ground truth" is established by compliance with recognized FDA guidance and ASTM standards that define safety and compatibility in the MR environment.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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