(151 days)
The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of:
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
- 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;
- 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: - Ununited humeral head fractures;
- 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:
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
- 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;
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component);
- Ununited humeral head fractures;
- 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:
- Rotator cuff tear arthropathy.
- 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:
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
- 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.
- 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:
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
- 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;
- 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: - Ununited humeral head fractures;
- 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:
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
- 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.
- 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:
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
- 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.
- 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:
- Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
- 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.
- 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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Magnetic Resonance (MR) compatibility of the shoulder systems. | Results demonstrated compatibility conditions of the subject devices in the MR environment. |
| Compliance with ASTM F2213 (Magnetically Induced Torque) | Demonstrated |
| Compliance with ASTM F2052 (Magnetically Induced Displacement Force) | Demonstrated |
| Compliance with ASTM F2119 (MR Image Artifacts) | Demonstrated |
| Compliance with ASTM F2182 (Radio Frequency Induced Heating) | Demonstrated |
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.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”