(28 days)
The Arthrex Low Profile Screws (2.0-3.0mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment 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 (3.5mm 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 and Small Fragment 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 Low Profile Screws are titanium or stainless steel, fully or partially threaded, solid or cannulated, self-tapping, headed screws. The screws range from 2.0mm to 4.0mm in diameter and in length from 8mm to 80mm.
This document is a 510(k) premarket notification for the "Arthrex Low Profile Screws". It details the device, its intended use, and its substantial equivalence to a predicate device. The purpose of the submission is primarily for sterilization method clearance and line extensions, rather than proving performance against acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML or comparative effectiveness, MRMC studies, or standalone algorithm performance, is not available in the provided document.
This document describes a traditional medical device (bone screws) and its regulatory submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data from a new clinical study with acceptance criteria.
However, I can extract information related to the device itself and its regulatory context:
1. A table of acceptance criteria and the reported device performance:
* Not applicable / Not provided. This document is a 510(k) submission based on substantial equivalence, not a clinical trial demonstrating performance against specific acceptance criteria. The "performance" assessment is based on the new device having similar design, materials, and intended use as the predicate device.
2. Sample size used for the test set and the data provenance:
* Not applicable / Not provided. No specific test set or data provenance from a clinical study is included in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable / Not provided. Ground truth establishment, as typically required for AI/ML device studies, is not part of this 510(k) submission for bone screws.
4. Adjudication method for the test set:
* Not applicable / Not provided.
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:
* Not applicable / Not provided. This is not a study for an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable / Not provided. This is not an algorithm-only device; it is a physical medical device.
7. The type of ground truth used:
* Not applicable / Not provided. The basis for clearance is substantial equivalence to a predicate device, not empirical ground truth data from a new study.
8. The sample size for the training set:
* Not applicable / Not provided. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established:
* Not applicable / Not provided.
Information that is present in the document:
- Device Name: Arthrex Low Profile Screws
- Regulation Number: 21 CFR 888.3040
- Regulation Name: Smooth or threaded metallic bone fixation fastener
- Regulatory Class: Class II
- Product Code: HWC, HRS
- Predicate Device: K103705: Arthrex Low Profile Screws
- Purpose of Submission:
- To obtain FDA clearance for the use of Gamma Irradiation and Ethylene Oxide sterilization for the Arthrex Low Profile Screws (which were previously cleared as non-sterile through K103705).
- To address the addition of 3.75mm Low Profile Screws and Low Profile Variable Angle Locking Screws as line extensions, being similar in design, identical in material, and intended use to the cleared predicate.
- Device Description: Titanium or stainless steel, fully or partially threaded, solid or cannulated, self-tapping, headed screws. Range from 2.0mm to 4.0mm in diameter and 8mm to 80mm in length.
- Intended Use (summarized): Internal bone fixation for fractures, fusions, osteotomies, and non-unions in various anatomical locations (ankle, foot, hand, wrist for smaller sizes; adding clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula for larger sizes), either as stand-alone screws or in a plate-screw system.
- Basis for Substantial Equivalence: The new screws are stated to be substantially equivalent to the predicate device because "the basic design features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety and effectiveness." The new sterilization methods and expanded sizes are also deemed to be within acceptable parameters when compared to the predicate.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.