(217 days)
The Arthrex Shoulder Humeral Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3-or4-fraqment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck. The Arthrex Shoulder Humeral Fracture Prosthesis is designed for cemented or non-cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.
The device consists of: a stem body with a height adjustment mechanism in the neck section, composed of titanium (Ti6Al4V); a metal head support also of titanium; the prosthesis head composed of Cr-CO alloy. This device may be used for total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.
This device is a shoulder prosthesis, and the provided text is a 510(k) summary and an FDA clearance letter. These documents describe the device, its intended use, and its substantial equivalence to predicate devices, but they do not contain any information about acceptance criteria or a study proving that the device meets specific performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The provided text only touches upon:
- Intended Use: Severe pain or significant disability from degenerative, rheumatoid, or traumatic disease/injury of the glenohumeral joint, including various types of fractures and avascular necrosis. It can be used for hemi- or total shoulder repair.
- Substantial Equivalence: The primary basis for clearance is that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.
In summary, the provided information does not include the details necessary to answer your request about acceptance criteria and a study proving their fulfillment.
§ 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.”