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The humeral components of the Global Total Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement which is indicated for:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surfaces are severely comminuted, separated from blood supply or where experience shows more conventional methods of treatment are unsatisfactory;
3. Other difficult clinical management problems where arthrodesis or resection are not acceptable (i.e., revision of a failed primary component).
   The glenoid components of the Global Total Shoulder are intended for cemented use only for the above indications.
   Hemi-shoulder replacement is also indicated for:
4. Ununited humeral head fractures of long duration;
5. Avascular necrosis of the humeral head.

The DePuy Global Total Shoulder Eccentric Humeral Head will be available in a variety of sizes which are designed with offset male tapers to be used with the currently marketed DePuy Global Total Shoulder Humeral Bodies and Glenoid Components. The male taper on the Global Total Shoulder Eccentric Humaral Head is shifted 4.0mm off the head center. This offset permits the head to be "dialed" to cover the cut surface of the proximal humerus. This allows placement of the head in a more anatornically aligned position.

This 510(k) summary does not contain information about a study that established acceptance criteria for a device's performance, nor does it provide data on device performance against such criteria.

Instead, this document is a Summary of Safety and Effectiveness for the DePuy Global™ Total Shoulder Eccentric Humeral Head. Its primary purpose, as a 510(k) submission, is to demonstrate substantial equivalence to a predicate device already legally marketed in the U.S., not to prove performance against specific acceptance criteria through a clinical or non-clinical study in the way one might for a novel diagnostic or AI device.

Here's why the requested information cannot be extracted from this document:

• Type of Device: This document describes an orthopedic implant (humeral head for a shoulder replacement), not an AI/ML-based device or a diagnostic tool that would typically have performance metrics like sensitivity, specificity, or accuracy established in a clinical study for regulatory submission.
• Regulatory Pathway: The 510(k) pathway establishes substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. This often relies on comparing design, materials, indications for use, and possibly bench testing, rather than extensive clinical performance studies that define acceptance criteria.
• Content: The document focuses on comparing the new eccentric humeral head to the predicate standard humeral head, highlighting their similarities in materials, sizes, intended use, and geometry (except for the 4.0mm offset). It explicitly states: "The subject Global Total Shoulder Eccentric Humeral Heads are identical in design to the predicate Global Total Shoulder (standard) Humeral Head with the exception that the male taper is offsel 4.0mm."

Therefore, it is not possible to fill out the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies, as these types of studies and performance metrics are not typically part of a 510(k) submission for this class of device.

The document states the basis for substantial equivalence is that the new device is similar to the predicate in design (except for eccentricity), materials, sizes, and intended use. The FDA letter confirms the device is substantially equivalent, allowing it to be marketed.

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