(67 days)
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.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | 4-Point Bend (ASTM F382-17): Statistically equivalent performance to predicate devices and reference devices. | Arthrex 2.4 mm Volar Distal Radius Plate System plates perform statistically equivalent to the additional predicate devices cleared under Arthrex Plates, Screws and Staples, K150456, which were originally cleared under primary predicate Arthrex Distal Radius Plate System, K131474. |
| MRI Safety | FDA guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213: Evaluation for MR Conditional labeling. | MRI force, torque, and image artifact testing were conducted in accordance with these standards. The device was evaluated for MR Conditional labeling. (The text does not explicitly state the quantitative results or confirm "MR Conditional" status, only that it was evaluated for it.) The primary predicate (K131474) was not evaluated for MR Safety. |
| Biocompatibility/Sterility | Bacterial Endotoxins Test (BET): Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Must meet pyrogen limit specifications. | Testing demonstrates that the sterile devices within the Arthrex Plates meet pyrogen limit specifications. |
| Material Composition | Plates: CP Grade 4 Titanium conforming to ASTM F67. Screws: Titanium Alloy conforming to ASTM F136. | Plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67. Screws are manufactured from Titanium Alloy conforming to ASTM F136. This is stated as equivalent to the primary predicate K131474. |
| Physical Dimensions | Plates: 2.26 mm thickness. Screws: 2.4 mm diameter. | Plates are 2.26 mm in thickness. Screws are 2.4 mm in diameter. This is stated as equivalent to the primary predicate K131474. |
| Shelf-life | Non-sterile plates: Unlimited shelf-life (equivalent to predicate). Sterile plates/screws: Labeled with a 5-year shelf-life. | Non-sterile Arthrex 2.4 mm Volar Distal Radius Plates have an unlimited shelf-life. Sterile Arthrex 2.4 mm Volar Distal Radius Plates and Arthrex Low Profile Screws are labeled with a 5-year shelf-life. |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.