(90 days)
The Arthrex KreuLock Compression Screws (2.0-3.0 mm solid) are intended to be used 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 Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.
The Arthrex KreuLock Compression Screws (3.5 mm and larger, solid) are intended to be used 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, calcaneus, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.
The Arthrex Compression FT Screws (2.0-3.0 mm 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 Compression FT Screws (3.5 mm 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, calcaneus, femur and fibula.
The Arthrex KreuLock Compression Screws are a family of screws that are offered in a diameter range of 2.4 to 4.5 mm, length range of 10 to 80 mm, in a fully threaded design, solid, and locking design. The Arthrex KreuLock Compression Screws are intended to be used with plates in the same applications as existing Arthrex Low Profile Screws. Those plates remain unchanged. The Arthrex KreuLock Compression Screws are manufactured from either Titanium or Stainless Steel materials and are available in straight or variable angle configurations. The screws are sold sterile or non-sterile and single-use.
The Arthrex Compression FT Screws are a family of screws that are offered in a diameter range of 2.8 to 7.0 mm, length range of 8 to 140 mm, in a fully threaded and cannulated design. The Arthrex Compression FT Screws are manufactured from Titanium. The screws are sold sterile or non-sterile and single-use.
This document describes the premarket notification (510(k)) for Arthrex Compression Screws (K201132). The primary focus of the performance data section is mechanical testing to demonstrate substantial equivalence to predicate devices, rather than a study involving a diagnostic AI device or human-in-the-loop performance. Therefore, most of the requested information (related to AI acceptance criteria, expert ground truth, MRMC studies, etc.) is not applicable to this submission.
However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the study performed:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Arthrex Compression Screws are based on demonstrating "statistical equivalence" to predicate devices in mechanical performance. The reported performance is that the device meets these criteria, showing substantial equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Statistical equivalence to predicate devices for: | |
| - Push-out strength | The submitted mechanical testing data demonstrates that the push-out strength of the proposed devices are substantially equivalent to that of the predicate devices. |
| - Insertion torque/failure torque | The submitted mechanical testing data demonstrates that the torque of the proposed devices are substantially equivalent to that of the predicate devices. |
| - Compression strength | The submitted mechanical testing data demonstrates that the compression strength of the proposed devices are substantially equivalent to that of the predicate devices. |
| MR Compatibility: Compliance with specified ASTM standards for: | Conducted per ASTM F2052-15 (displacement force), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact), and ASTM F2182-11a (RF Heating). (The text states these tests were "conducted," implying they met the standards for MR compatibility without providing specific numerical results, usually indicating successful completion as per regulatory expectations.) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the mechanical testing (e.g., number of screws tested for each mechanical property). Mechanical testing typically involves a set number of samples per configuration (e.g., diameter, length, material) to achieve statistical significance.
The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective" because this is mechanical testing, not a clinical study involving human patient data. It's an engineering test performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of mechanical testing, is established by scientific principles and validated testing methodologies, not by expert human interpretation. The "truth" is the measured mechanical property.
4. Adjudication method for the test set
Not applicable. There is no human interpretation or subjective assessment that requires adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This is a mechanical device, not an AI or imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (screws), not an algorithm.
7. The type of ground truth used
The ground truth for this study is derived from:
- Physical measurements: The actual measurements of push-out force, insertion/failure torque, and compression strength.
- Standardized testing methods: Adherence to established mechanical testing standards (e.g., for strength, torque) and specific ASTM standards for MR compatibility.
- Statistical comparison: The performance is compared statistically to the known performance of predicate devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of mechanical device submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for mechanical testing.
§ 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.