(136 days)
The Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid).
The Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mimi Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm).
The Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module consists of a series of plates and screws of varying lengths and thickness. The plates are contoured to fit the various aspects of the hand, wrist, foot and ankle including Straight, T-, Y-, V-, Cage, Triangular and Bridge. The plates are attached to bone with 2.0 mm and 2.4 mm cortical and variable locking screws. The screws range from 2.0 mm to 2.4 mm in diameter and from 6 mm to 40 mm in length. The plates and screws are manufactured from titanium. The plates and screws are sold non-sterile and single-use.
The provided document describes a 510(k) premarket notification for a medical device, the "Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module." This device is a bone fixation system, consisting of plates and screws, intended for treating fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments.
The study presented in this document is a mechanical performance study designed to demonstrate substantial equivalence to a predicate device, not a study involving human subjects or AI-assisted interpretation of medical images. Therefore, many of the requested criteria (like sample size for test set, number of experts, reader studies, ground truth establishment for training, etc.) are not applicable in this context.
Here's a breakdown of the acceptance criteria and study as described in the document, focusing on what is relevant for a mechanical device submission:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence in mechanical performance to a legally marketed predicate device (K063049: Synthes (USA) Modular Mini Fragment LCP System). The performance data presented are for the mechanical properties of the device components (plates and screws).
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Pull-out strength (ASTM F543) | "statistically equivalent to the predicate" |
| Insertion torque/failure torque | "statistically equivalent to the predicate" |
| Static four-point bend (ASTM F382) | "statistically equivalent to the predicate" |
| Four-point bend fatigue testing (ASTM F382) | "statistically equivalent to the predicate" |
Summary of Conclusion: "The submitted mechanical testing data demonstrates that the pull-out, torque, bending strength and the fatigue strength of the proposed devices are substantially equivalent to that of the predicate device for the desired indications."
Details of the Study
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Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample sizes used for each mechanical test. Mechanical tests typically involve a certain n number of samples per test type and comparison group (new device vs. predicate).
- Data Provenance: The data is generated from in vitro mechanical testing. The document does not specify the country of origin of the data beyond "Arthrex Inc." being located in Naples, Florida, USA. Since it's a mechanical test, the concept of "retrospective or prospective" as applied to clinical data is not directly applicable; it's a controlled laboratory study.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a mechanical device, and "ground truth" is established by direct physical measurement according to established ASTM standards, not by expert interpretation of images or clinical outcomes.
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Adjudication Method for the Test Set:
- Not Applicable. As a mechanical test, there is no expert adjudication in the classic sense. The comparison to the predicate device would be based on statistical analysis of the measured mechanical properties.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is relevant for AI or imaging devices where human readers interpret medical images. This document describes mechanical testing of a bone fixation system.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The Type of Ground Truth Used:
- The "ground truth" for this type of submission is the measured physical properties of the device and the predicate device according to standardized testing protocols (ASTM F543, ASTM F382). The goal is to show these physical properties are "substantially equivalent."
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The Sample Size for the Training Set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
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How the Ground Truth for the Training Set was Established:
- Not Applicable. As mentioned, this is not an AI/machine learning device.
In summary, this 510(k) submission relies on demonstrating the mechanical and material equivalence of the new bone fixation system to a predicate device through standardized in vitro laboratory testing, rather than clinical trials or AI performance evaluations.
§ 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.