(152 days)
The Arthrex Mini Comprehensive Fixation System Plates (1.4-1.6 mm) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid).
The Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (1.4-1.6 mm).
The Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm 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 and wrist including straight, T-, Y-, Z-, Hook, Triangular, Cage and Bridge configurations. The plates are attached to bone with 1.4 mm and 1.6 mm cortical and variable locking screws. The screws range from 1.4 mm to 1.6 mm in diameter and from 6 mm to 24 mm in length. The plates and screws are manufactured from titanium. The plates and screws are sold non-sterile and single-use.
The provided text is related to a 510(k) premarket notification for the "Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm Module." This document describes the device and claims substantial equivalence to a predicate device based on mechanical testing. However, it does not describe a study involving "acceptance criteria" and "reported device performance" in the context of AI/ML or diagnostic device performance as typically expected when asking about such criteria. Instead, the "performance data" section refers to mechanical testing of a physical medical device (plates and screws).
Therefore, most of the requested information regarding AI/ML study components (sample size, data provenance, expert consensus, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document.
Here's the relevant information that can be extracted, interpreted based on the document's context as a medical device 510(k) submission:
Acceptance Criteria and Device Performance (Mechanical Testing)
The document states that studies were conducted to demonstrate that the proposed device performs "statistically equivalent to the predicate" device. While explicit numerical acceptance criteria aren't listed as a table, the goal of the testing was to show equivalence in specific mechanical properties.
Table of Acceptance Criteria and Reported Device Performance (as inferred for mechanical equivalence):
| Performance Metric | Acceptance Criteria (Inferred from "Statistically Equivalent") | Reported Device Performance (Summary) |
|---|---|---|
| Pull-out Strength (ASTM F543) | Statistically equivalent to predicate device | Achieves statistical equivalence to predicate device |
| Insertion Torque/Failure Torque | Statistically equivalent to predicate device | Achieves statistical equivalence to predicate device |
| Static Four-Point Bend (ASTM F382) | Statistically equivalent to predicate device | Achieves statistical equivalence to predicate device |
| Four-Point Bend Fatigue (ASTM F382) | Statistically equivalent to predicate device | Achieves statistical equivalence to predicate device |
| Bending Strength | Statistically equivalent to predicate device | Achieves statistical equivalence to predicate device |
| Fatigue Strength | Statistically equivalent to predicate device | Achieves statistical equivalence to predicate device |
Information Not Applicable or Not Provided in the Document:
Due to the nature of the device (a physical bone fixation system) and the type of submission (510(k) for substantial equivalence based on mechanical testing), the following requested information is not applicable or not provided in the document:
- Sample size used for the test set and the data provenance: This refers to the mechanical components tested. The exact quantity of individual plates and screws tested is not specified, nor is their origin (e.g., manufacturing batches). It's a physical product test, not a data-driven study in the AI/ML sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not relevant for mechanical performance testing.
- Adjudication method: Not applicable for mechanical performance testing.
- 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, as this is a physical medical device, not an AI/ML diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is the established ASTM standards and the performance of the predicate device.
- The sample size for the training set: Not applicable, as this device does not involve an AI/ML algorithm or a "training set."
- How the ground truth for the training set was established: Not applicable.
§ 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.