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The Arthrex 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, and wrist. 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 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, 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 Compression FT Screws (2.0-3.0 mm 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, and wrist.

The Arthrex Compression FT Screws (3.5 mm 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, calcaneus, femur and fibula.

The Arthrex KreuLock Compression Screws are a family of screws that are offered in a diameter range of 2.4 to 4.5 mm, length range of 10 to 80 mm, in a fully threaded design, solid, and locking design. The Arthrex KreuLock Compression Screws are intended to be used with plates in the same applications as existing Arthrex Low Profile Screws. Those plates remain unchanged. The Arthrex KreuLock Compression Screws are manufactured from either Titanium or Stainless Steel materials and are available in straight or variable angle configurations. The screws are sold sterile or non-sterile and single-use.

The Arthrex Compression FT Screws are a family of screws that are offered in a diameter range of 2.8 to 7.0 mm, length range of 8 to 140 mm, in a fully threaded and cannulated design. The Arthrex Compression FT Screws are manufactured from Titanium. The screws are sold sterile or non-sterile and single-use.

This document describes the premarket notification (510(k)) for Arthrex Compression Screws (K201132). The primary focus of the performance data section is mechanical testing to demonstrate substantial equivalence to predicate devices, rather than a study involving a diagnostic AI device or human-in-the-loop performance. Therefore, most of the requested information (related to AI acceptance criteria, expert ground truth, MRMC studies, etc.) is not applicable to this submission.

However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the study performed:

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

The acceptance criteria for the Arthrex Compression Screws are based on demonstrating "statistical equivalence" to predicate devices in mechanical performance. The reported performance is that the device meets these criteria, showing substantial equivalence.

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

The document does not specify the exact sample sizes used for the mechanical testing (e.g., number of screws tested for each mechanical property). Mechanical testing typically involves a set number of samples per configuration (e.g., diameter, length, material) to achieve statistical significance.

The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective" because this is mechanical testing, not a clinical study involving human patient data. It's an engineering test performed in a lab setting.

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 mechanical testing, is established by scientific principles and validated testing methodologies, not by expert human interpretation. The "truth" is the measured mechanical property.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or subjective assessment that requires adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This is a mechanical device, not an AI or imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a physical medical device (screws), not an algorithm.

7. The type of ground truth used

The ground truth for this study is derived from:

• Physical measurements: The actual measurements of push-out force, insertion/failure torque, and compression strength.
• Standardized testing methods: Adherence to established mechanical testing standards (e.g., for strength, torque) and specific ASTM standards for MR compatibility.
• Statistical comparison: The performance is compared statistically to the known performance of predicate devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of mechanical device submission.

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

Not applicable, as there is no training set for mechanical testing.

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The Arthrex Compression Screws are intended for fixation of fractures, osteotomies and arthrodesis in:

• carpal, metacarpal and small hand bones .
• . tarsal and metatarsals
• . phalanges
• . intra-articular fractures
• . ankle
• . proximal and distal humerus
• . proximal and distal radius
• . proximal and distal ulna
• . osteochondral fixation and fractures
• . osteochondritis dissecans
• . fixation of fractures and osteotomies about the knee
• . oblique fractures of the fibula
• . reconstructive surgeries of the foot
• malleolar fixation

where size of offered implant is patient appropriate.

The Arthrex Compression Screws are a family of titanium, cannulated, compression screws that are offered in a diameter range of 5.0 to 7.0mm, length range of 20 to 140mm, in a fully threaded design.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex Compression Screws, formatted as requested:

This document is a 510(k) premarket notification for Arthrex Compression Screws. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with human readers or AI. Therefore, many of the requested fields related to AI performance, human reader studies, and large-scale ground truth establishment are not applicable.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document mentions "Shear, push-out, torque, and compression testing" which are mechanical tests performed on the devices themselves, not tests involving human anatomical samples or patient data.
   • The specific sample sizes for these mechanical tests are not provided in the summary.
   • Data provenance is not applicable as it's not clinical data or images.

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

   • Not applicable. The "ground truth" here refers to the performance of the predicate device for comparison in mechanical testing. Expert consensus related to diagnostic imaging or clinical outcomes is not involved.

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

   • Not applicable, as there's no clinical test set requiring adjudication.

4. 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 MRMC study was done. This is a medical device (bone fixation screw) and the submission is for its substantial equivalence, not an AI-powered diagnostic or assistive tool.

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

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

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

   • The "ground truth" for comparison was the performance characteristics of the legally marketed predicate device (K132217: Arthrex Compression FT Screws) as measured through mechanical testing. This is a benchmark against a predicate device's established mechanical properties.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning device, so there is no "training set."

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

   • Not applicable, as there is no training set.

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