(77 days)
The DePuy Global Shoulder Glenoid is intended for use as a cemented glenoid component in total shoulder replacement which is indicated for:
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
- Fracture-dislocations of the proximal humerus where the articular surfaces are severely compromised or where conventional methods of treatment are unsatisfactory;
- Other difficult clinical management problems where arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The glenoid components of the Global Total Shoulder System are intended for cemented use only for the above indications.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures of long duration
- Avascular necrosis of the humeral head
The DePuy Global Shoulder Glenoid is intended use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the DePuy Global Total Shoulder System. The DePuy Global Shoulder Glenoid is manufactured in six sizes from Ultra High Molecular Weight Polyethylene (UHMWPe). The articular (lateral) surface is designed to articulate with the head of an existing, commercially available Global Shoulder humeral prosthesis. The fixation (medial) surface is convex and is designed with four pegs, one centrally located peg and three peripheral pegs placed in a triangular configuration. The center peg is fitted with radially extending fins which provide resistance to pullout. The space around the peripheral pegs is designed to provide interdigitation with cement. The main rotational motion caused by translation of the prosthetic humeral head is possible in the prosthetic humeral head.
The provided document is a 510(k) premarket notification for the DePuy Global Shoulder Glenoid. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a de novo clinical study to establish new acceptance criteria and prove performance against those criteria. Therefore, the information requested in points 1 through 9, which relate to a study proving device performance against specific acceptance criteria, is not directly available in this document.
However, I can extract information related to the device description, intended use, and the basis of substantial equivalence as provided.
Device Description and Intended Use:
The DePuy Global Shoulder Glenoid is intended for use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the DePuy Global Total Shoulder System. It is manufactured in six sizes from Ultra High Molecular Weight Polycht Polychylcuce (UHMWPe) and is designed to articulate with the head of an existing, commercially available Global Shoulder humeral prosthesis. The fixation surface is convex and designed with four pegs (one central, three peripheral) for interdigitation with cement.
Intended Use for the Global Total Shoulder System (of which this glenoid is a component):
The humeral components are intended for cemented total shoulder replacement for:
- Severely painful and/or disabled joints resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis.
- Fracture-dislocations of the proximal humerus where articular surfaces are severely compromised or conventional methods are unsatisfactory.
- Other difficult clinical management problems (e.g., revision of a failed primary component).
The glenoid components are intended for cemented use only for the above indications.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures of long duration.
- Avascular necrosis of the humeral head.
Basis of Substantial Equivalence:
The DePuy Global Shoulder Glenoid is considered substantially equivalent to the currently marketed cemented DePuy Global Shoulder Pegged and Keeled Glenoid components. The basis of equivalence is in terms of:
- Material (UHMWPe)
- Articular and fixation surface geometries
- Use as the cemented glenoid components of the Global Total Shoulder System.
Regarding the specific points 1-9 for a study proving acceptance criteria:
Based on the nature of a 510(k) submission, this document does not contain a study designed to prove the device meets pre-defined acceptance criteria through a specific clinical or performance trial with calculated sample sizes, ground truth establishment, or expert adjudication as typically seen in novel device approvals or performance claims.
Therefore, I cannot provide the requested information:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on equivalence, not setting new performance criteria.
- Sample size used for the test set and the data provenance: Not provided. No specific "test set" for a performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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: This is not an AI device, so an MRMC study is not relevant here and is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI device.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
The document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, allowing the DePuy Global Shoulder Glenoid to enter the market. It does not outline a clinical study proving its performance against novel acceptance criteria. The "study" here is the comparison to the predicate device to satisfy the substantial equivalence requirements of the 510(k) pathway.
§ 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.”