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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 antegrade femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.

The retrograde femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections. Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions, and fractures resulting from osteoporosis.

The tibial nail system is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The tibial nail system is indicated for long bone fracture fixation of tibial fractures, which may include the following: traverse, oblique, spiral, segmental and comminuted fractures with bone loss and bone transport; open and closed fractures; pathologic fractures; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral fractures, proximal and distal non-unions and malunions and revisions procedures.

The ES trochanteric nail is intended to treat stable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

The Arthrex Intramedullary Nails are comprised of Femoral, Tibial, and Trochanteric Nail Systems.

The proposed Arthrex Femoral Nail System is comprised of femoral nails (antegrade, retrograde, supracondylar retrograde), proximal and distal locking screws, end caps, spacer, and washers. All retrograde nails are threaded on the distal end to accept an end cap. The proximal and distal locking screws are comprised of fully threaded, cancellous or cortical screws and partially threaded cancellous screws. The Arthrex Femoral Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136). The Arthrex Femoral Nail System is sold sterile and is single-use.

The proposed Arthrex Tibial Nail System is comprised of tibial nails, proximal and distal locking screws, end caps, and spacer of varying lengths and diameters. The tibial nail contains slots to accept the locking screws. The proximal and distal locking and blocking screws are comprised of fully threaded, cortical screws and partially threaded cannulated cancellous screws. The end caps are designed to prevent bony in-growth in the distal portion of the nail implant. The spacer is provided for proximal locking. The Arthrex Tibial Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI confirming to ASTM F136). The Arthrex Tibial Nail System is sold sterile and single-use.

The proposed Arthrex Trochanteric Nail System is comprised of trochanteric nails (short, ES [Extended Short], and long), proximal and distal locking screws, and end caps. The trochanteric nails have slots to accept distal and proximal screws. The proximal end of the nail is threaded to accept an end cap. The Arthrex Trochanteric Nail System (nails, screws, and end caps) is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136) and Stainless Steel (316LVM conforming to ASTM F138).

The provided FDA 510(k) summary (K230257) for the Arthrex Intramedullary Nails does not contain information related to software or AI/ML components. Therefore, it does not include acceptance criteria, study details, or performance metrics typically associated with such devices.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through:

• Technological Comparison: Highlighting that the intended use, fundamental scientific technology, design, material, sterility, and shelf-life are identical or have minor modifications that do not raise new questions of safety or effectiveness.
• Performance Data for Hardware Components: Detailing tests performed on the physical device components and packaging, such as:
  • Packaging validation and 5-year accelerated aging shelf-life testing (conforming to ISO 11607).
  • MRI safety testing (force, torque, image artifact, radiofrequency induced heating) in accordance with FDA guidance and ASTM standards (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213).
  • Bacterial Endotoxins Test (BET) to ensure pyrogen limit specifications are met (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14).

Therefore, I cannot answer questions 1 through 9 as they pertain to the evaluation of AI/ML or software performance. The device described is a physical medical implant (intramedullary nails) and the clearance is based on its similarity to existing, cleared hardware.

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The Arthrex 2.4 mm Volar Distal Radius Plate System is internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal, or orthogonal application.

The Arthrex Low Profile Screws (2.4 mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.

The Arthrex 2.4 mm Volar Distal Radius Plate System consists of a series of plates and screws of varying lengths and orientations. The Arthrex 2.4 mm Volar Distal Radius Plates are 2.26 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67. The plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.

The Arthrex Low Profile Screws are a family of fully threaded, solid, non-locking screws. The screw family is offered in 2.4 mm in diameter and range in lengths from 6 mm to 40 mm. The screws are manufactured from Titanium Alloy conforming to ASTM F136. The screws are sold sterile (Gamma) and are single-use.

The provided text describes the Arthrex 2.4 mm Volar Distal Radius Plate System and Arthrex Low Profile Screws. It outlines the device's intended use and performance data as part of a 510(k) premarket notification.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant ASTM and AAMI standards.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "testing" (e.g., 4-Point Bend testing, MRI testing, BET) but does not provide specific sample quantities for each test.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission for a medical device designed for fracture fixation, the testing would typically be conducted under controlled laboratory conditions rather than involving human patient data at this stage. It's safe to assume the testing is prospective and controlled in nature.

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

• This information is not provided in the given text. The studies described are primarily mechanical, material, and safety tests rather than clinical studies requiring expert interpretation of results to establish ground truth. The "ground truth" for these tests are the objective measurements against established standards.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies described are laboratory-based performance and safety tests, not clinical evaluations requiring adjudication of subjective outcomes.

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

• This is not applicable. The device described is a physical implant (plate and screws) for internal bone fixation, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• This is not applicable as the device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

• The ground truth used for the reported studies is based on objective measurements and adherence to established industry standards (ASTM, AAMI, USP, EP) and FDA guidance for device performance, material properties, and safety (e.g., strength, dimensions, pyrogen limits, MRI compatibility).

8. The Sample Size for the Training Set

• This is not applicable as the device is a physical implant, not a machine learning model requiring a training set.

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

• This is not applicable for the same reason as above.

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