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Total or hemi-shoulder replacement is indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
4. Rotator cuff tear arthropathy.

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.

The Global Fx porous-coated humeral stem is intended for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating.

Porocoat® Porous-Coated Components
Porocoat® Porous-coated humeral stem prostheses are indicated for cementless use with fixation provided by biological tissue in-growth into the porous coating.

Cemented Components
Humeral stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.

The Porous-coated Global Fx humeral stem is a modified Global Fx humeral stem. Porocoat® porous coating has been added to the proximal portion of the stem. The stem is manufactured from cobalt-chromium --molybdenum alloy conforming to ASTM F-75. The stem mates with humeral heads previously cleared as Global Advantage Head (K984541), Global Advantage CTA Heads (K000575) and the Global Advantage Eccentric Humeral Head (K992065).

This 510(k) summary is for a medical device called the "Global™ Fx Porous-Coated Humeral Stem." This document does not describe any acceptance criteria or studies proving the device meets performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device for marketing clearance.

Therefore, most of the requested information regarding acceptance criteria, device performance, and study details like sample size, ground truth, and expert involvement is not available within the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The document does not describe performance acceptance criteria for the device itself or report any performance metrics against such criteria. The focus is on demonstrating substantial equivalence to a predicate device, meaning it is considered safe and effective because it is very similar to an already legally marketed device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not available. There is no test set described for evaluating the device's performance. The review is based on a comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not available. No ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not available. No test set or adjudication method is described.

5. 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. This device is a physical shoulder implant and not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This device is a physical shoulder implant and not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not available. No ground truth is described as there are no performance studies outlined here. The "ground truth" for regulatory clearance in this context is the predicate device's existing clearance, implying its safety and effectiveness.

8. The sample size for the training set:

• Not applicable/Not available. There is no "training set" in the context of this device, which is a physical implant. The substantial equivalence argument relies on engineering analysis and comparison to an existing device, not machine learning model training.

9. How the ground truth for the training set was established:

• Not applicable/Not available. As above, no training set is relevant here.

Summary of Device Comparison for Substantial Equivalence (the main "study" in this document):

• Predicate Device: Global Fx Humeral Stem (K984541)
• Key Similarity: Both humeral stems have identical locking tapers, are tapered in design, come in similar sizes, and are manufactured from the same materials (cobalt-chromium-molybdenum alloy conforming to ASTM F-75).
• Key Difference (and reason for this 510(k)): The addition of Porocoat® porous coating to the proximal portion of the new Global™ Fx Porous-Coated Humeral Stem.
• Outcome: The FDA found the device "substantially equivalent" to the predicate device, allowing it to be marketed. This decision is based on the similarities described and the understanding that the addition of porous coating for biological tissue in-growth (rather than cementless use) is well-understood and fits within the regulatory framework for similar devices.

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