Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device