(153 days)
The Arthrex Univers Revers Modular Glenoid System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's ioint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Arthrex Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Arthrex Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex Univers Revers Modular Glenoid System cleared under K173900 consists of a monoblock or modular baseplate that is centrally anchored by a central screw or post for cementless use with peripheral screws, a glenosphere, and humeral insert as part of the Univers Revers Shoulder Prosthesis System, K142863.
This Special 510(k) introduces size 45 glenospheres manufactured from Cobalt Chromium (CoCr) and as well as combination humeral inserts manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), same materials as K173900.
The provided text is an FDA 510(k) Summary for the Arthrex Univers Revers Modular Glenoid System. It describes the device, its indications for use, and how it was determined to be substantially equivalent to a predicate device.
However, this document does NOT contain information about a study proving the device meets acceptance criteria for an AI/ML-enabled medical device.
The 510(k) summary focuses on the mechanical and material properties of the shoulder prosthesis components (glenospheres and humeral inserts). The acceptance criteria and "study" described are related to:
- Mechanical testing: Fatigue testing, corrosion testing, and PE/Cup interface testing. These demonstrate that the new sizes of the device perform equivalently to the predicate device in terms of physical integrity.
- Biocompatibility testing: Bacterial Endotoxin testing. This ensures the device meets pyrogen limit specifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-enabled medical device meets its acceptance criteria based on the provided text, as the document is about a mechanical orthopedic implant, not an AI/ML device.
To answer your request, I would need a document detailing the evaluation of an AI/ML-enabled medical 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.”