(28 days)
The VariAx® Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.
This Special 510(k) submission is intended to add aiming blocks as an accessory to the VariAx® Distal Radius plate line which was cleared in K040022 and K100271. The aiming blocks are accessories used intra-operatively to guide the user in placement of the screws into the plate. There are 4 aiming blocks which correspond to the configurations of volar plates: Narrow Right, Narrow Left, Standard Right and Standard Left. The aiming blocks are used with a joystick tool which helps the user find the appropriate screw trajectory and is pinned in place once the desired alignment is obtained. Kirschner wires can also be used in conjunction with the aiming blocks to determine screw trajectory.
This document describes a Special 510(k) submission for the VariAx® Distal Radius Locked Plating System Line Extension, specifically for the addition of aiming blocks. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (K040022 and K100271).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Torque to failure (joystick and block assembly) must withstand clinically relevant loads. | "Torque to failure was performed using the joystick and the block assembled and failure loads were found to be acceptable." |
| Lateral loads on the construct must result in acceptable failure modes (e.g., disassembly without significant damage). | "Lateral loads were also placed on the construct and the failure mode was disassembly without significant damage to the plate." |
| Biocompatibility: | |
| Materials (PEEK and stainless steel) must be biocompatible. | "Biocompatibility testing of the materials in the aiming block assembly (PEEK and stainless steel) was conducted..." |
| Sterility: | |
| Device must be sterile. | "...as well as cleanability testing, sterility testing..." |
| Cleanability: | |
| Device must be cleanable. | "...cleanability testing..." |
| Corrosion Resistance: | |
| Device must be corrosion resistant. | "...and corrosion resistance testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each benchtop test (torque to failure, lateral loads, biocompatibility, cleanability, sterility, corrosion resistance). It only mentions that these tests "were conducted." The data provenance is from non-clinical benchtop testing, performed by the manufacturer, Howmedica Osteonics Corp., in the USA (implied, given the company's address). This is a prospective test in the sense that it was conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for a medical device accessory and relies on benchtop mechanical and material testing, not clinical data or expert evaluation of images/data for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical study involving human judgment or interpretation, therefore no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required for this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense. The "standalone" performance here refers to the device's intrinsic mechanical and material properties as assessed through benchtop testing, without human judgment playing a direct role in evaluating its primary function (guiding screw placement). The tests focused on the physical integrity and safety of the aiming blocks themselves.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on engineering specifications, material science standards, and established regulatory requirements for mechanical performance, biocompatibility, sterility, cleanability, and corrosion resistance for medical devices. The "acceptance" of the "failure loads" for torque and lateral tests implies a pre-defined threshold or range considered safe and effective based on industry standards for bone fixation devices.
8. The Sample Size for the Training Set
Not applicable. This submission is for a hardware accessory and involves benchtop testing, not machine learning or AI, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
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.