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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 FibuLock Nail is intended for use in the fixation of fibula fractures and osteotomies.

The Arthrex FibuLock Nail is used in the Fibula Repair System cleared under K160069. It is a stainless steel implant used with stainless steel bone screws for the fixation of fibula fractures and osteotomies. The Arthrex FibuLock Nail can be used with existing FDA cleared Arthrex Low Profile Cortical Screws (K141478, K143139 and K143614), Arthrex TightRope Syndesmosis Devices (K043248) and instrumentation required for the fixation of fibula fractures and osteotomies.

The provided text describes the Arthrex FibuLock Nail, its predicate device, and the basis for its 510(k) clearance. However, it does not contain information related to acceptance criteria, human reader studies (MRMC), standalone algorithm performance, or ground truth establishment for a study proving device performance in the context of AI/ML.

The "Performance Data" section briefly mentions "Worst-Case Cross-Section Comparison" and "Axial pullout and torsion comparison testing," which are mechanical performance tests typical for orthopedic implants, not studies involving AI or human readers for diagnostic tasks.

Therefore, many of the requested details, particularly those pertaining to AI/ML device evaluation, cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

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

• Test Set Sample Size: Not applicable. This document describes mechanical testing for an orthopedic implant, not a study with a "test set" of patient data for diagnostic or predictive purposes.
• Data Provenance: Not applicable. The "data" refers to mechanical test results, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert diagnosis, pathology) is not relevant for the mechanical testing described.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. This document does not mention any MRMC studies or human reader performance.

6. If a standalone (algorithm only) performance study was done:

• No. This document describes a physical medical device (an intramedullary nail), not an algorithm or AI system.

7. The type of ground truth used:

• Not applicable. The relevant "ground truth" for this device would be its mechanical properties meeting engineering specifications, which is assessed through direct mechanical testing, not expert consensus or histopathology.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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The Arthrex Fracture Plates are intended to be used 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, calcaneous, and fibula.

The Arthrex Low Profile Screws (2.5mm 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, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Fracture Plates are a family of flat and contoured plates and screws. The plates are comprised of stainless steel and come in a variety of configurations. The Arthrex Fracture Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed Low Profile Screws, in this submission, are comprised of Stainless Steel and are 2.7mm in diameter and range from 32mm to 60mm in length.

The provided text is a 510(k) premarket notification for the Arthrex Fracture Plates and accompanying screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested categories for AI/ML study description (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a mechanical performance study to demonstrate substantial equivalence.

Here's the information that can be extracted relevant to acceptance criteria and the "study" conducted for this type of device:

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

The document describes material and mechanical testing to demonstrate substantial equivalence. It implies that the acceptance criteria for these tests were met by being comparable to the predicate devices. The specific raw data or numerical acceptance limits are not provided in this summary, but the conclusion of meeting them is stated.

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

• Sample size: Not explicitly stated for the mechanical tests in this summary. Mechanical tests typically involve a small number of samples of the device and predicate.
• Data provenance: The tests were "in-vitro testing" conducted by the manufacturer, Arthrex, Inc., in the USA (Naples, FL).

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

• Not applicable. This pertains to mechanical testing, not expert-based evaluation of medical images.

4. Adjudication method for the test set:

• Not applicable. This pertains to mechanical testing.

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:

• No. This is not an AI/ML device, and no MRMC study was performed.

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

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

7. The type of ground truth used:

• Mechanical properties comparison to predicate devices. The "ground truth" here is the established mechanical performance of legally marketed predicate devices, against which the new device's performance is compared.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

Summary of what the document does say about the "study":

The study conducted was in-vitro mechanical testing (4-point bend, section modulus comparison, torque) to compare the performance of the Arthrex Fracture Plates and screws to their predicate devices. The conclusion was that the "performance of the proposed devices is substantially equivalent to that of the predicate devices" and that "The mechanical data indicate that the Arthrex Fracture Plates are adequate for their intended use." The document explicitly states: "Clinical data and conclusions are not needed for this device."

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