Search Results

• · Fixation of Metaphyseal Fractures of the Distal Tibia
• · Proximal Metaphyseal Tibial Fractures
• · Calcaneus Body Fractures
• · Proximal Humeral Head/Shaft Fractures
• · Distal Femur Fracture Comminuted Shaft Fractures
• · Fixation of soft tissue, such as tendon and ligaments, to bone

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.

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.

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• · Fixation of Metaphyseal Fractures of the Distal Tibia
• · Proximal Metaphyseal Tibial Fractures
• · Calcaneus Body Fractures
• · Proximal Humeral Head/Shaft Fractures
• · Distal Femur Fracture -- Comminuted Shaft Fractures

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. 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.

The provided text describes a 510(k) submission for a medical device called the "DePuy ACE Spider Plate." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the input does not contain information about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for the training set was established.

The document focuses on establishing substantial equivalence to a predicate device (Acumed Suture Washer) based on similar design and function, rather than presenting a performance study against predefined acceptance criteria.

Ask a specific question about this device