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The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of:

1. A severely painful and/or disabled joint resulting from osteoarthritis 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).
   The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemi-shoulder replacement for the treatment of:
4. Ununited humeral head fractures;
5. Avascular necrosis of the humeral head.
   The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
   The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears.
   The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods:
   POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
   Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
   Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of:

1. A severely painful and/or disabled joint resulting from osteoarthritis 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. Ununited humeral head fractures;
5. Avascular necrosis of the humeral head.
   The DePuy GLOBAL FX Shoulder System is indicated for the following fixation methods:
   POROCOAT™ Porous-Coated Components Porocat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
   Cemented Components Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
   Press-fit or Cemented Components Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended as a total or hemi-shoulder replacement in patients where the humeral head and neck are of sufficient bone stock cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing alignment; restoring flexion and extension movement: and resisting dislocation.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
The DePuy GLOBAL ™ CAP CTA Resurfacing Shoulder is indicated only for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

1. Rotator cuff tear arthropathy.
2. Difficult clinical management problems where other methods of treatment may not be inadequate.
   The DePuy GLOBAL ™CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only.

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surface is severely communited, 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).
   Glenoid components are intended for cemented use only.

The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:

1. A severely painful and/or disabled joint resulting from osteoarthritis 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).
   The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of:
4. Ununited humeral head fractures;
5. Avascular necrosis of the humeral head.
   The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
   The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears.
   The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods:
   POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
   Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
   Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.

The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surface is severely communited, 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).
   Glenoid components are intended for cemented use only.

The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:

1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surfaces are severely communited, 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).
   Glenoid components are intended for cemented use only.

The DELTA CTA™ Reverse Shoulder Prosthesis is indicated for use in:

1. Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
2. The DELTA CTA™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
3. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
   For US use only: All components are intended for cemented use only

The Global Shoulder System is comprised of multiple brands (Global Advantage, Global FX, Global AP, Global CAP, Global APG and Global Steptech), each comprised of different components (humeral stems, humeral heads and glenoids) intended for hemiand/or total-shoulder arthroplasty.
The DELTA CTA System is comprised of components intended for reverse shoulder arthroplasty.

This is a 510(k) premarket notification for various DePuy shoulder systems (Global Shoulder, Delta CTA, etc.). The document details the device names, indications for use, and a comparison to predicate devices, focusing on the addition of MRI compatibility labeling.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-clinical testing performed to support MRI compatibility. The reported device performance is that these tests demonstrated compatibility.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for AI performance. Instead, it refers to non-clinical testing for MRI compatibility.

• Sample size: Not applicable or not specified in terms of patient numbers. The testing was done on the devices themselves.
• Data provenance: Not applicable. These are physical tests on the medical devices, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission is about the physical device and its MRI compatibility, not an AI/ML device requiring expert-established ground truth from medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. This refers to the adjudication of clinical review for AI/ML performance, which is not relevant here. The tests performed are standardized engineering tests.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For the MRI compatibility testing, the "ground truth" would be the specifications and limits defined by the ASTM standards themselves. The physical properties of the devices are measured against these established limits.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no training set mentioned or implied.

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

Not applicable. There is no training set for this device.

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