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The Arthrex Spine Compression FT Screws are intended to stabilize the spine as an aid to fusion through immobilization of the facet joints, either through bilateral transfacet fixation, or unilateral transfacet fixation when used contralateral to pedicle screw fixation. The Arthrex Spine Compression FT Screws are intended to be used with or without bone graft, at a single or multiple levels, from C2 to S1, for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations. The Arthrex Spine Compression FT Screw is also indicated for fracture fixation of small bones and bone fragments including pars interarticularis and odontoid. The fracture fixation of pars interarticularis is indicated for the adult and adolescent population (12 to 21 years of age).

The Arthrex Spine Compression FT Screws are headless, threaded, cannulated titanium implants that are available in a variety of sizes. The screws have a fully threaded screw shaft with a tapering head and a variable-stepped thread pitch that allows the screw the ability to provide compression and stability between bony fragments or joints.

The provided FDA approval letter heavily focuses on the regulatory and administrative aspects of the device, primarily confirming its substantial equivalence to predicate devices based on non-clinical performance data. It does not contain information about a study proving specific acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance (MRMC), or detailed clinical trial information.

The document discusses the mechanical performance of the Arthrex Spine Compression FT Screw, which is a physical medical device (a screw for spinal fixation), not a software or AI-driven diagnostic tool. Therefore, many of the requested points (e.g., sample size for test set, ground truth for test set, number of experts, MRMC study, standalone algorithm performance, training set details) are not applicable to the type of device described in this FDA letter.

However, based on the information provided, I can infer and state what is available regarding the device's performance demonstration:

Device: Arthrex Spine Compression FT Screw

Purpose of Submission: To obtain clearance for the Arthrex Spine Compression FT Screws for spine indications, demonstrating substantial equivalence to predicate devices.

Type of Device: A physical, implantable medical device (a screw for spinal fixation), not an AI/software diagnostic tool.

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a physical device, the "acceptance criteria" discussed are related to its mechanical performance and safety for implantation and MR compatibility, not diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for mechanical or MR compatibility testing. These are typically bench tests following established standards, not patient-based test sets.
• Data Provenance: The studies are described as "non-clinical testing" conducted by Arthrex. This implies in-house laboratory testing. Not applicable to country of origin, retrospective/prospective data as these are not clinical trials.

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

• Not applicable. The "ground truth" for mechanical and MR compatibility tests is defined by the test standards (e.g., ASTM F2193, F2182-19, F2119-13) and physical measurements, not by expert interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation, not for bench testing of mechanical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is designed to assess human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is a surgical implant, not a diagnostic AI tool.

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

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

7. The Type of Ground Truth Used:

• For mechanical testing: Engineering specifications and direct physical measurements according to validated test methods (ASTM standards).
• For MR compatibility: Measurements against established safety limits and comparisons to predicate devices, verified through standardized test methods (ASTM standards) and in-vivo electromagnetic simulation.

8. The Sample Size for the Training Set:

• Not applicable. This device does not use a training set as it is not an AI/machine learning product.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

Important Note:

The letter does mention, "A clinical literature summary was provided to support the expansion of indications." This indicates that existing clinical data from published literature was used to support the broadened indications for use of the device, rather than a new, dedicated clinical trial being conducted for this 510(k) submission. However, details of this literature review are not provided in the letter.

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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 Pilon Fusion Plates are intended to be internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous.

The Arthrex Low Profile 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, 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 Pilon Fusion Plate System are a family of contoured plates and screws. The Arthrex Pilon Fusion Plates are manufactured from Titanium conforming to ASTM F136 and are available in a variety of configurations. The Arthrex Pilon Fusion Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed plates are sold sterile or non-sterile and single use.

The proposed Arthrex Low Profile Screws are offered in a 3.5mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The screws are manufactured from Titanium conforming to ASTM F136 and are sold sterile or non-sterile and single-use.

The provided FDA 510(k) clearance letter and summary for the Arthrex Pilon Fusion System do not contain information about a study proving that a device meets acceptance criteria related to artificial intelligence (AI) or software performance.

The document describes a medical device, which is a system of plates and screws for internal bone fixation. The performance data presented refers to mechanical testing of the plates and screws (e.g., insertion torque, failure torque, 4-point bend testing, pull-out testing) to demonstrate substantial equivalence to predicate devices. There is also mention of MR compatibility testing.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/software device meets acceptance criteria from the provided text.

Based on the nature of the document (510(k) for orthopedic implants), it is highly unlikely to contain such information. This type of submission focuses on the physical and mechanical properties of the device, biocompatibility, and substantial equivalence to existing predicate devices, not AI or software performance.

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The Arthrex Mesh Plates are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, osteopenic bone and patella fractures.

The Arthrex Mesh Plates are manufactured from either titanium alloy or stainless steel. The plates are 1.3 mm thick in a semi-contoured, mesh-like design. The plates are available in long and short versions ranging from 50 mm to 115 mm in length. The plates are designed for the surgeon to cut to a desired length as needed. The Arthrex Mesh Plates are intended to be used with existing FDA cleared Arthrex screws. The Arthrex Mesh Plates are sold sterile and non-sterile and are single use.

The document describes the acceptance criteria and supporting studies for the Arthrex Mesh Plates, a medical device, not an AI/ML product. Therefore, several points in your request related to AI/ML devices (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.

Here's a breakdown of the available information regarding the acceptance criteria and studies for the Arthrex Mesh Plates:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This information is typically relevant for AI/ML device studies. This submission pertains to a physical medical device (bone fixation plates). The mechanical and other tests would have specific sample sizes as per relevant ASTM/ISO standards, but these details are not provided in this summary.

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

• Not Applicable. Ground truth, in the context of expert review, is typically relevant for AI/ML devices where human expert judgment is used to label data. For a physical device, performance is evaluated against engineering specifications and regulatory standards.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods are typically used in clinical studies or for setting ground truth in AI/ML performance evaluation based on expert consensus.

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. MRMC studies are specific to AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical implant.

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

• Not Applicable. This refers to AI/ML algorithm performance without human intervention, which is not relevant for a physical implantable device.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by engineering standards, regulatory guidelines (e.g., FDA guidance for MR safety, ISO 10993 for biocompatibility), and direct mechanical testing against predicate device performance. It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device might be. The goal is to demonstrate equivalence to a legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. "Training set" is a concept specific to AI/ML model development.

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

• Not Applicable. This is specific to AI/ML model development.

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The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for fixation of bone fractures and fusions in the foot and ankle. The Arthrex Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile Screws.

The Arthrex Minimally Invasive Ankle Fusion Plate is a Titanium bone fixation device intended to be permanently implanted. The implant is contoured with a tapered proximal end and contoured bend on the distal end. The implant has a 3-hole design and is 1.74 inches in length. The implant is single-use and may be available in sterile and non-sterile versions.

The Arthrex Minimally Invasive Ankle Fusion Plate is a bone fixation device intended for permanent implantation to fix bone fractures and fusions in the foot and ankle, to be used with Arthrex Low Profile Screws. The device is made of Titanium, has a 3-hole design, and is 1.74 inches in length.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided document for each specific test. However, the document refers to "testing conducted" generally.
• Data Provenance: Not explicitly stated. The studies are laboratory-based performance tests evaluating the physical and biological properties of the device, rather than clinical data from human subjects.

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

This information is not applicable. The studies conducted are mechanical and material property tests against established engineering and biological standards (ASTM F382-17, FDA Guidance for MRI Safety, ANSI/AAMI ST72, etc.), not studies relying on expert interpretation of medical data. Therefore, there is no "ground truth" in the clinical sense established by medical experts for these tests. The "ground truth" is defined by the objective performance criteria outlined in the standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly for diagnostic devices where multiple readers might interpret data to establish a consensus ground truth. The studies performed here are objective laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

No. An MRMC comparative effectiveness study is not discussed. This device is a bone fixation plate, not an AI-powered diagnostic or assistive technology.

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

No. This information is not applicable as the device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted (static bending, fatigue bending, MRI safety, bacterial endotoxins) is based on established engineering and biological standards and specifications. For instance, the mechanical tests are compared against the performance of a predicate device cleared under K141735, implying that the predicate's performance against ASTM F382-17 served as the benchmark ("ground truth") for equivalence. The Bacterial Endotoxins Test has specific pyrogen limit specifications as its "ground truth."

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical implant and does not involve AI or machine learning models that require training sets.

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

This information is not applicable, as there is no training set for this device.

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The Arthrex Mesh Plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.

The Arthrex Low Profile Screws (3.0 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 Mesh Plates.

The Arthrex Mesh Plate System is a family of plates and screws made from stainless steel and titanium. The system is comprised of the Arthrex Mesh Plates and accompanying Arthrex Low Profile Screws. The proposed plates in long and short versions are offered sterile and non-sterile.

The accompanying screws are 3.0 mm low profile screws with lengths ranging from 42 mm to 50 mm. The proposed screws are offered sterile and non-sterile.

The provided document is a 510(k) premarket notification for the Arthrex Mesh Plate System, which is a metallic bone fixation appliance and accessories. This type of regulatory submission demonstrates substantial equivalence to legally marketed predicate devices, rather than proving device safety and effectiveness through clinical studies with acceptance criteria as one would find for novel devices or software with AI/ML components.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets.

Instead, the submission relies on:

• Mechanical testing performed in accordance with ASTM F 382-14 (Standard Specification and Test Method for Metallic Bone Plates).
• Bacterial endotoxin testing in accordance with USP .
• Demonstration of substantial equivalence to predicate devices (K111253: Arthrex Distal Extremity Plate System, K143614: Arthrex Low Profile Screws, and K150456: Arthrex Plates, Screws, and Staples) based on intended use, technological characteristics, and mechanical testing data for bending strength, fatigue testing of plates, and torque and pull-out testing of screws.

The document explicitly states: "Any differences between the Arthrex Mesh Plate System and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This indicates that the regulatory pathway is based on demonstrating similarity to existing, approved devices, not on de novo clinical performance studies with specific statistical acceptance criteria that would typically be associated with AI/ML devices.

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