(74 days)
The Arthrex Fracture System is intended to be used 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 Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.
The Arthrex Fracture System is a family of stainless steel plates, screws, and buttons that will be offered as sterile or non-sterile devices. The plates may be contoured or straight and may be available in left and right configurations. The screw family ranges from 2.7mm to 4.0mm in diameter and from 8mm to 80mm in length. The screws are solid and fully threaded and may be locking or non-locking. The button is stainless steel and designed to fit securely in the holes of the fracture plates. The button is intended to be used with the previously cleared suture, which is provided separately.
This document is a 510(k) premarket notification for the Arthrex Fracture System, focusing on the sterilization methods of Gamma Irradiation and Ethylene Oxide (EO). The purpose of the submission is to obtain clearance for sterile versions of a device previously cleared as non-sterile (K112437).
Based on the provided information, it's essential to understand that this submission is for a medical device (bone fixation plates, screws, and buttons), not an AI-powered diagnostic or assistive tool. Therefore, many of the requested criteria related to AI performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable to this type of device submission.
Here's a breakdown of the requested information, addressing what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of accuracy, sensitivity, or specificity, as these are typically associated with diagnostic or AI performance. The "acceptance criteria" for a medical device like this are generally related to its physical and mechanical properties, biocompatibility, and sterility, ensuring it performs its intended function safely and effectively.
The "reported device performance" is essentially the determination of substantial equivalence to a predicate device. The claim is that the Arthrex Fracture System, with the addition of sterilization, is substantially equivalent to the predicate device (K112437). This equivalence is based on:
- Identical intended use: Internal bone fixation for fractures, fusions, osteotomies, and non-unions in various anatomical locations.
- Similar material: Stainless steel.
- Fundamental technological characteristics: Plates, screws, and buttons for bone fixation.
- Sterilization validation: The critical new aspect for this submission is the validation of Gamma Irradiation and Ethylene Oxide (EO) sterilization processes, ensuring the device remains safe and effective after these treatments. This is implied to have met relevant standards, though details are not provided in this summary.
| Acceptance Criteria (Implied for Device Safety/Effectiveness related to Sterilization) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Device remains safe and effective after Gamma Irradiation sterilization. | The submission states that the "purpose of submission is intended to address the use of Gamma Irradiation and Ethylene Oxide sterilization on the Arthrex Fracture System devices, which were originally cleared as non-sterile devices... The intended use, material, and fundamental technological characteristics of the proposed Arthrex Fracture System are substantially equivalent to the non-sterile predicates." This implies that the sterilization processes were validated to ensure the device's safety, effectiveness, and material compatibility were maintained, meeting the necessary standards for these sterilization methods, leading to a determination of substantial equivalence. |
| Device remains safe and effective after Ethylene Oxide (EO) sterilization. | |
| Intended Use, Material, and Fundamental Technological Characteristics match predicate. | The Arthrex Fracture System is substantially equivalent to the predicate devices (K112437) in which the basic design features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document. This is a submission for a physical medical device, not an AI/software product requiring a "test set" in the computational sense. The "test set" would be related to mechanical testing, biocompatibility, and sterilization validation, which are typically performed according to established ISO standards and are not described in terms of "samples" in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. "Ground truth" and "experts" in this context would refer to material scientists, engineers, and microbiologists conducting various tests to validate the device's properties and the effectiveness of the sterilization processes. This document is a summary and does not contain that level of detail.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for subjective interpretations, especially in diagnostic imaging or clinical trials, which is not the nature of this device's evaluation.
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 information is not applicable and not provided. MRMC studies and the concept of "human readers" improving with AI assistance are specific to AI/CAD (Computer-Aided Detection/Diagnosis) systems, which this device is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is for a physical orthopedic implant system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided in the context of AI. For a physical device, the "ground truth" would be established by scientific and engineering principles, material specifications, and validated test methods (e.g., mechanical strength testing, biocompatibility testing, sterility assurance level (SAL) validation for sterilization). These details are not part of the 510(k) summary.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" for this type of medical device submission.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" or "ground truth" establishment in the AI sense for this device.
§ 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.