FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

AI/ML Overview

This document is a 510(k) summary for the DePuy ACE Spider Plate, seeking to expand its intended uses. It explicitly states that "The DePuy ACE Spider Plate has been previously cleared by the FDA for fracture fixation. Intended Uses are being expanded to include the fixation of soft tissue, such as tendon and ligaments, to bone."

The provided text does not contain information about specific acceptance criteria or a study proving the device meets them, especially not for the expanded indication. This document is a regulatory submission for substantial equivalence, not a clinical study report.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone performance (algorithm only) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Acumed Suture Washer) for the expanded indication of soft tissue fixation.

The key statements supporting this are:

"The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures."
"The Acumed Suture Washer (K965028) is intended for soft tissue fixation, small and large bone fixation and is used in conjunction with a titanium bone screw."
"The DePuy ACE Spider Plate and the Acumed Suture Washer are similar in design and function. Based on the above, DePuy ACE Medical Company considers the DePuy ACE Spider Plate to be substantially equivalent to the Acumed Suture Washer."

The FDA's response confirms substantial equivalence based on the submitted information for the expanded indications.

Summary

Regulation Number and Section

§ 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.