(144 days)
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.
| Acceptance Criterion Type | Acceptance Criterion (as described) | Reported Device Performance (as described) |
|---|---|---|
| Mechanical Performance | Statistically equivalent to predicate devices K123241, K103705, and K143614 for: Pull-out, Failure Torque, Insertion Torque (ASTM F543-17), and 4-Point Bend (ASTM F382-17). | The Arthrex Ankle Fracture System performs "statistically equivalent to the predicate devices cleared under K123241, K103705 and K143614." The submitted data "demonstrates that the Pull-out, 4-Point Bend strength and Failure Torque/Insertion Torque... is substantially equivalent to that of the predicate devices." |
| MRI Compatibility | Compliant with FDA guidance and specified ASTM standards (F2052, F2119, F2182, F2213) for force, torque, and image artifacts. | MRI force, torque, and image artifact testing were conducted in accordance with the specified FDA guidance and ASTM standards. The device was evaluated for MR Conditional labeling. |
| Sterility / Pyrogenicity | Meet pyrogen limit specifications per ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14 using Kinetic Chromogenic Method. | Testing "demonstrates that the sterile devices... meet pyrogen limit specifications." |
| Physical Attributes | Not introduce additional risks or concerns regarding sterilization and shelf-life compared to predicates. | Assessment determined that the system "does not introduce additional risks or concerns regarding sterilization and shelf-life." |
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.
§ 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.