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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 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 are a family of screws that are offered in a 3.5 mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The Arthrex Low Profile Screws are manufactured from Stainless Steel materials conforming to ASTM F138. The screws are sold sterile or non-sterile and single-use.

This document is a 510(k) summary for the Arthrex Low Profile Screws. It describes mechanical testing performed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating device performance against pre-defined acceptance criteria for a diagnostic algorithm. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not specified. The document mentions "mechanical testing data" but does not quantify the number of screws or tests performed.
• Data provenance: Not explicitly stated, however, as mechanical testing, it would be laboratory-generated data, not from human subjects or clinical settings, thus neither retrospective nor prospective in the typical sense for clinical data. It would be considered prospective for the testing itself.

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

• Not Applicable. This document describes mechanical testing of a physical device, not the evaluation of a diagnostic tool against a ground truth established by experts.

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

• Not Applicable. Adjudication methods are relevant for clinical studies involving reader interpretations, not for 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:

• Not Applicable. This is a 510(k) for a medical screw, not an AI or diagnostic imaging device.

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

• Not Applicable. This document is for a physical medical device, not an algorithm.

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

• Not Applicable. For mechanical testing, the "ground truth" would be the measured physical properties and performance metrics of the previous devices as a benchmark for comparison.

8. The sample size for the training set:

• Not Applicable. This document describes mechanical testing, not a machine learning model or algorithm that requires a training set.

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

• Not Applicable. See point 8.

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The Arthrex Low Profile Screws are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates.

The Arthrex Low Profile Screws are headed and self-tapping screws manufactured from Titanium. They are available as fully and solid. The screw family ranges from 4.5 mm to 5.5 mm in diameter and from 80 mm to 120 mm in length (in 5 mm increments). The Arthrex Low Profile Screws are sold as sterile, single-use and non-sterile single-use.

This document is a 510(k) premarket notification for the "Arthrex Low Profile Screws," a medical device intended for internal bone fixation. It does not describe a study involving an AI/algorithmic device or a comparative effectiveness study with human readers.

Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for an AI/algorithmic device is not present in the provided text. The document focuses on the substantial equivalence of a physical medical device (screws) to a predicate device based on design, materials, and mechanical/safety testing.

Here's an attempt to answer the relevant questions based on the provided text, and highlighting what's not present:

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

Based on the "Performance Testing" section, the acceptance criteria relate to mechanical strength (driving torque, failure torque/insertion), MRI safety (force, torque, image artifact), and pyrogenicity. The exact numerical acceptance criteria are not specified in this summary, only that testing was "conducted in accordance with FDA guidance" and "demonstrates that the Arthrex Low Profile Screws meets pyrogen limit specifications."

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

For the physical device testing (mechanical, MRI, biological), the sample sizes are not explicitly stated.
The data provenance is from Arthrex Inc. as part of this 510(k) submission. It's a pre-market submission, implying the data was generated to support the clearance, not necessarily from a large-scale clinical trial. The testing appears to be primarily lab-based and engineering verification rather than human clinical data.

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

This is not applicable as the document describes a physical medical device, not an AI/algorithmic device requiring expert ground truth in the context of diagnostic/image interpretation. The "ground truth" here would be the physical properties and safety profiles verified through engineering and biocompatibility testing.

4. Adjudication method for the test set

This is not applicable for the type of testing described (mechanical, MRI safety, pyrogenicity for a physical orthopedic screw).

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. This document is for a physical orthopedic screw, not an AI/algorithmic device.

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

This is not applicable. This document is for a physical orthopedic screw, not an AI/algorithmic device.

7. The type of ground truth used

For the described device, the "ground truth" is established through:

• Engineering specifications and standards: For mechanical properties (torque, strength).
• FDA Guidance Documents: For MRI safety testing protocols and acceptable limits.
• Pharmacopoeia/Standards (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14): For bacterial endotoxin levels.

8. The sample size for the training set

This is not applicable. There is no machine learning "training set" described for this physical device. The device itself is manufactured; it does not learn from data.

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

This is not applicable as there is no training set for an AI/ML model for this device.

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The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal 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 and Small Fragment Plates.

The Arthrex Low Profile Screws (2.0-3.0mm 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 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 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 and Small Fragment 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 Arthrex Low Profile Screws are titanium or stainless steel, fully or partially threaded, solid or cannulated, self-tapping, headed screws. The screws range from 2.0mm to 4.0mm in diameter and in length from 8mm to 80mm.

This document is a 510(k) premarket notification for the "Arthrex Low Profile Screws". It details the device, its intended use, and its substantial equivalence to a predicate device. The purpose of the submission is primarily for sterilization method clearance and line extensions, rather than proving performance against acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML or comparative effectiveness, MRMC studies, or standalone algorithm performance, is not available in the provided document.

This document describes a traditional medical device (bone screws) and its regulatory submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data from a new clinical study with acceptance criteria.

However, I can extract information related to the device itself and its regulatory context:

1. A table of acceptance criteria and the reported device performance:
* Not applicable / Not provided. This document is a 510(k) submission based on substantial equivalence, not a clinical trial demonstrating performance against specific acceptance criteria. The "performance" assessment is based on the new device having similar design, materials, and intended use as the predicate device.

2. Sample size used for the test set and the data provenance:
* Not applicable / Not provided. No specific test set or data provenance from a clinical study is included in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable / Not provided. Ground truth establishment, as typically required for AI/ML device studies, is not part of this 510(k) submission for bone screws.

4. Adjudication method for the test set:
* Not applicable / Not provided.

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 / Not provided. This is not a study for an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable / Not provided. This is not an algorithm-only device; it is a physical medical device.

7. The type of ground truth used:
* Not applicable / Not provided. The basis for clearance is substantial equivalence to a predicate device, not empirical ground truth data from a new study.

8. The sample size for the training set:
* Not applicable / Not provided. There is no "training set" in the context of this traditional medical device submission.

9. How the ground truth for the training set was established:
* Not applicable / Not provided.

Information that is present in the document:

• Device Name: Arthrex Low Profile Screws
• Regulation Number: 21 CFR 888.3040
• Regulation Name: Smooth or threaded metallic bone fixation fastener
• Regulatory Class: Class II
• Product Code: HWC, HRS
• Predicate Device: K103705: Arthrex Low Profile Screws
• Purpose of Submission:
  • To obtain FDA clearance for the use of Gamma Irradiation and Ethylene Oxide sterilization for the Arthrex Low Profile Screws (which were previously cleared as non-sterile through K103705).
  • To address the addition of 3.75mm Low Profile Screws and Low Profile Variable Angle Locking Screws as line extensions, being similar in design, identical in material, and intended use to the cleared predicate.
• Device Description: Titanium or stainless steel, fully or partially threaded, solid or cannulated, self-tapping, headed screws. Range from 2.0mm to 4.0mm in diameter and 8mm to 80mm in length.
• Intended Use (summarized): Internal bone fixation for fractures, fusions, osteotomies, and non-unions in various anatomical locations (ankle, foot, hand, wrist for smaller sizes; adding clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula for larger sizes), either as stand-alone screws or in a plate-screw system.
• Basis for Substantial Equivalence: The new screws are stated to be substantially equivalent to the predicate device because "the basic design features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety and effectiveness." The new sterilization methods and expanded sizes are also deemed to be within acceptable parameters when compared to the predicate.

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