(90 days)
Total Shoulder or hemi-shoulder replacement is indicated for:
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis 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 humeral components of the Global AP™ Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.
Glenoid components of the Global AP™ Shoulder are indicated only for use with bone cement for the above indications.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures;
- Avascular necrosis of the humeral head.
- Deformity and/or limited motion.
The Global AP™ Shoulder Prosthesis consists of individually packaged metal humeral stem, metal head, taper assembly for use in total shoulder arthroplasty. In addition, previously cleared DePuy Global UHMWPE or crosslinked UHMWPE glenoids are used as compatible components in total shoulder arthroplasty.
A Hemi-Shoulder Prosthesis replaces the proximal humerus by either resurfacing the head or using a metal humeral stem and head in hemi-shoulder arthroplasty.
This 510(k) summary describes a premarket notification for a medical device (DePuy Global AP™ Shoulder System) and declares its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets them in the context of performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/software-as-a-medical-device (SaMD) clearances.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred about the "acceptance criteria" and "study" in this context:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial Equivalence to Predicate Devices: |
- Same Intended Use
- Same Indications for Use
- Similar Design
- Similar Materials
- Similar Packaging
- Similar Sterilization
- No new issues of safety or effectiveness raised | The DePuy Global AP™ Shoulder System is stated to be substantially equivalent to the DePuy Global™ Advantage Shoulder System (K992065), the Sulzer Anatomical Shoulder System with Removable Heads (K030259), and the Sulzer Orthopedics Anatomica Humeral Stem/Head (K990137) based on these criteria. The device is intended to perform the same function for the same indications as the predicates. |
Explanation: In the context of a 510(k) submission for a non-software medical device, "acceptance criteria" for clearance typically revolve around demonstrating substantial equivalence to a legally marketed predicate device. This means showing that the new device is as safe and effective as the predicate. The "study" here is the 510(k) submission itself, which presents data and arguments to support this claim of substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/SaMD performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/SaMD performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not an AI/SaMD performance study.
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/SaMD and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense of an AI/SaMD performance study. The "ground truth" for substantial equivalence is based on the known safety and effectiveness of the existing predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/SaMD.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/SaMD.
§ 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.”