(170 days)
The Arthrex Fracture Plates are 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, fibula.
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, and Distal Extremity Plates.
The Arthrex Low Profile Screws (2.0-3.0mm 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, and wrist.
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, Fracture 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 Arthrex Fracture Plates are a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50 mm to 244 mm in length. The accompanying screws are 2.5mm to 6.7mm in diameter.
Here's a breakdown of the acceptance criteria and study information for the Arthrex Fracture Plates, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Devices) | Reported Device Performance (Arthrex Fracture Plates) |
|---|---|
| Material Composition: Must be composed of materials substantially equivalent to predicate devices. | Composed of Titanium or Stainless Steel, which is substantially equivalent to the predicate devices. |
| Bending Strength: Bending strength must be substantially equivalent to predicate devices. | The mechanical testing data demonstrated that the bending strength of the proposed devices is substantially equivalent to the bending strength of the predicate devices. |
| Pull-out Strength: Pull-out strength must be substantially equivalent to predicate devices. | The mechanical testing data demonstrated that the pull-out strength of the proposed devices is substantially equivalent to the pull-out strength of the predicate devices. |
| Torque Strength: Torque strength must be substantially equivalent to predicate devices. | The mechanical testing data demonstrated that the torque strength of the proposed devices is substantially equivalent to the torque strength of the predicate devices. |
| Indications for Use: Must have equivalent indications for use to predicate devices. | The indications for use are the same as the predicate devices (internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in various specified anatomical locations). |
| Technological Characteristics: Must have technological characteristics comparable to predicate devices. | The technological characteristics are comparable to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the study described is a benchtop mechanical testing study, not a clinical study involving patients or human data. The "test set" would refer to the physical devices (fracture plates and screws) subjected to mechanical stress tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable. Ground truth, in the context of this 510(k) submission, is established by objective mechanical testing standards and comparison to predicate device performance, not expert consensus on human data.
4. Adjudication Method for the Test Set
This is not applicable. There is no adjudication method described as it's a mechanical performance study, not involving human interpretation or decision-making.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (fracture plates and screws) and primarily relies on mechanical performance testing for substantial equivalence, not a comparison of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study (algorithm only) was not done. This device is a physical implant, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" used for demonstrating substantial equivalence is objective mechanical performance data (bending, pull-out, and torque strength) and material composition standards, compared against that of legally marketed predicate devices.
8. Sample Size for the Training Set
This is not applicable, as this is a physical medical device submission based on mechanical testing and material equivalence, not an AI/machine learning study. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set" for this type of device submission.
§ 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.