(42 days)
The Arthrex Distal Radius Plate System is intended for 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, nonunions and malunions.
This system can be used for palmar, dorsal or orthogonal application.
The Arthrex Low Profile Screws (2.0-2.4mm 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 Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as standalone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (2.7mm and larger, solid) are intended to be used as standalone 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, Fracture Plates, Distal Extremity Plates, Distal Radius 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 Arthrex Distal Radius Plate System is a family of plates offered in various widths, thicknesses and lengths and locking screws in various diameters and lengths.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bending strength comparable to predicate device | Demonstrated to be comparable |
| Fatigue strength comparable to predicate device | Demonstrated to be comparable |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or algorithm performance. The evaluation was based on mechanical testing data.
- Sample size for mechanical testing: Not explicitly stated.
- Data provenance: Not specified (e.g., in-house lab, third-party lab, etc.).
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)
Not applicable. The study was mechanical testing, not a clinical study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The study was mechanical testing, not a clinical study requiring adjudication.
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
No MRMC comparative effectiveness study was done. This is a medical device (plate and screw system) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" implicitly refers to the mechanical properties (bending strength and fatigue strength) of the predicate devices. The new device's performance was compared against these established properties.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI model.
Summary of the Study:
The submission for the Arthrex Distal Radius Plate System is a traditional 510(k) premarket notification. The primary evidence presented for substantial equivalence to predicate devices is based on mechanical testing.
The study demonstrated that:
- The materials used (titanium) are substantially equivalent to those in predicate devices.
- The bending strength of the proposed devices is comparable to that of the predicate device.
- The fatigue strength of the proposed devices is comparable to that of the predicate device.
These mechanical performance comparisons are the basis for the FDA's determination of substantial equivalence, indicating that the device meets its acceptance criteria by performing similarly to already legally marketed devices.
§ 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.