(49 days)
The Arthrex Ankle Fusion Plating 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, and fibula.
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 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, Osteotomy Plates, and Ankle Fusion Plating System.
The Arthrex Ankle Fusion Plating System is a family of implantable titanium plates and screws 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, and fibula.
The subject plates are contoured and may be available in left and right configurations, ranging in length from 91.9mm to 133.6mm. The accompanying screws are solid or cannulated, fully or partially threaded, and may be locking or non-locking. The proposed screw offering subject of this application are 4.5mm to 6.7mm in diameter and 16mm to 120mm in length and include the partially threaded cannulated lag screws and 13mm washer previously cleared in K123241.
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, and 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, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.
The provided text describes a 510(k) premarket notification for the Arthrex Ankle Fusion Plating System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics against ground truth. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment is not present in the provided document.
Here's a breakdown of what can be extracted, and where the requested information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission aims to demonstrate "substantial equivalence" to the predicate device.
- Reported Device Performance: The document states: "mechanical testing data demonstrates that the four-point bending, pull-out and insertion torque strength of the proposed Arthrex Ankle Fusion Plating System devices are substantially equivalent to or better than the four-point bending, pull-out and insertion torque strength of the predicate devices." No specific numerical values or comparison data are provided in this summary.
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 present in the provided document. The device is a physical orthopedic implant, and the evaluation mentioned is mechanical testing, not a clinical study involving human patients where "test set" and "data provenance" would be applicable in the sense of patient data.
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 present. Ground truth in the context of mechanical testing would refer to established engineering standards or the performance of the predicate device, not expert human assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not present. Adjudication methods are typically used in clinical studies where human interpretation of data is involved, which is not the primary focus of this 510(k) summary.
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 present. This is a medical device for bone fixation, not an AI or imaging diagnostic tool. An MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not present. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a 510(k) submission of a bone fixation device, the "ground truth" for demonstrating substantial equivalence is typically based on mechanical testing against established engineering standards or the performance of the predicate device. The document refers to "mechanical testing data" for "four-point bending, pull-out and insertion torque strength."
8. The sample size for the training set
- This information is not present. A "training set" is relevant for machine learning algorithms, not for physical medical implants undergoing mechanical testing for substantial equivalence.
9. How the ground truth for the training set was established
- This information is not present for the same reason as point 8.
In summary, the provided document is a 510(k) summary for a bone fixation device, which focuses on demonstrating substantial equivalence through mechanical testing rather than presenting a clinical study with detailed acceptance criteria, ground truth establishment, or clinical performance metrics as would be seen for a diagnostic or AI-driven 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.