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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 3.5 mm Locking Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

The Arthrex 3.5 mm Locking Compression Plates consists of a series of varying lengths. The Arthrex 3.5 mm Locking Compression Plates range from 70 mm to 278 mm in length and 3.5 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from Titanium Alloy (ASTM F136) and Stainless Steel (ASTM F138). The proposed plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.

The provided document is a 510(k) premarket notification for a medical device: Arthrex 3.5 mm Locking Compression Plates (K222244). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a new AI-powered diagnostic device meets specific performance criteria.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, is not present in this document. This is because the device described is a physical implant (bone fixation plates), not an AI/medical imaging diagnostic system.

The document describes material testing and mechanical performance to demonstrate equivalence between the new plates and existing predicate devices.

Here's a breakdown of the relevant information provided in the document:

• Device Type: Arthrex 3.5 mm Locking Compression Plates – a physical metallic implant for bone fixation.
• Purpose of Submission: To obtain 510(k) clearance for the new plates by demonstrating substantial equivalence to a predicate device (K123241: Arthrex Fracture Plates).
• Performance Data: The document mentions physical and mechanical testing, not AI model performance.
  • 4-Point Bend Testing (ASTM F382-17): Conducted to demonstrate statistical equivalence in strength to the predicate device.
  • MRI Force, Torque, and Image Artifact Testing: Performed in accordance with FDA guidance and ASTM standards (e.g., ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213) to evaluate MR compatibility.
  • Bacterial Endotoxins Test (BET): Utilizes the Kinetic Chromogenic Method (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14) to confirm pyrogen limit specifications for sterile devices.
• No AI, Machine Learning, or Diagnostic Study Details: The document does not contain any information about the acceptance criteria or studies typically associated with AI/ML-driven diagnostic devices. There is no mention of:
  • Sensitivity, Specificity, AUC, or other diagnostic performance metrics.
  • Test/training data sets, their sizes, or provenance.
  • Expert involvement in establishing ground truth for diagnostic purposes.
  • Adjudication methods.
  • MRMC studies.
  • Standalone algorithm performance.

In summary, the provided document relates to the 510(k) clearance of a physical medical device (bone plates) and therefore does not contain the information required to answer the prompt regarding AI device acceptance criteria and studies.

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The Arthrex Fracture Plates are intended to be used for internal bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibula.

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, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws 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.

The proposed Arthrex Ankle Fracture System consists of a series of plates and screws of varying lengths and orientations for versatile treatment of distal tibia fractures. The Ankle Fracture System Plates consist of posterior and vertical plates that are anatomically contoured to provide fixation in the talus and may be available in left and right configurations. Each plate provides locking screw fixation. The proposed Arthrex Low Profile Screws are a family of fully threaded, solid, non-locking or locking screws; and partially threaded, cannulated and non-locking screws. The proposed plates and screws are manufactured from Titanium Alloy. The proposed plates and screws are sold sterile (Gamma) and non-sterile and are single-use.

The provided document is a 510(k) Premarket Notification from the FDA for the Arthrex Ankle Fracture System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and comparison of technological characteristics.

Crucially, this document does not describe a study involving an AI/software medical device. Therefore, most of the requested information regarding AI performance criteria, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training/test sets is not applicable to this submission.

The "Performance Data" section explicitly states the types of tests performed:

• Mechanical Testing: Pull-out (ASTM F543-17), Failure Torque, Insertion Torque (ASTM F543-17), and 4-Point Bend (ASTM F382-17). These tests compare the mechanical performance of the new device to predicate devices.
• MRI Compatibility Testing: MRI force, torque, and image artifact testing based on FDA guidance and ASTM standards (F2052, F2119, F2182, F2213).
• Sterility Testing: Bacterial Endotoxins Test (BET) in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14.

Here's a breakdown of the applicable information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criterion for mechanical testing was to demonstrate that the Arthrex Ankle Fracture System performs "statistically equivalent" to the predicate devices. Specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) are not provided in this summary document, but rather implied by the statistical equivalence claim. Similarly, for MRI compatibility and sterility, the acceptance criterion is compliance with the specified ASTM/USP standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the specific number of physical samples (e.g., plates, screws) tested for each mechanical or MRI test. Typically, these tests involve a statistically relevant number of samples to generate the reported data, but the exact number is not disclosed in this summary.
• Data Provenance: The data is generated from in vitro laboratory testing of the physical device components (plates and screws). This is not retrospective or prospective patient data from a specific country of origin, but rather engineering test data derived from manufactured devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This submission is for a physical medical device (bone fixation system), not an AI/software device that requires expert review of medical images or data to establish ground truth. The "ground truth" for this device's performance is derived from standardized physical and mechanical tests.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/software device involving subjective interpretations (like image readings), there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is relevant to AI/software devices that assist human readers (e.g., radiologists) in diagnostic tasks. For a bone fixation system, an MRMC study is not applicable.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance Study

• Not Applicable. There is no AI algorithm being evaluated. The device's performance is its physical properties.

7. The Type of Ground Truth Used

• Engineering Test Results / Standardized Measurements: The ground truth for this device's performance is established through measurable physical properties (e.g., pull-out force, bending strength, torque) obtained from well-defined and standardized laboratory tests (ASTM, USP, ANSI/AAMI standards). Comparison is made against predicate devices' measured performance.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/software device that requires a "training set" of data for machine learning.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

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