(266 days)
The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment.
- The cemented primary humeral stem, longrevision stems, and all Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the surgeon.
- . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- . Humeral Heads are intended for use in cemented and press-fit applications.
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows: - Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
- Congenital abnormalities in the skeletally mature
- Primary and secondary necrosis of the humeral head.
- Humeral head fracture with displacement of the tuberosities
- Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
- Displaced three-part and four-part upper humeral fractures
- Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
- Revision of failed previous reconstructions when distal anchorage is required
- To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Reverse Shoulder System is in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Equinoxe Platform Fracture Stem is in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
The Central Screw Baseplate System is comprised of devices that will be included as part of the Exactech Equinoxe® Shoulder System for reverse total shoulder arthroplasty (rTSA). The Central Screw Baseplate System includes Glenoid Baseplates, Central Compression Screws, a Locking Plate, a Locking Nut, and a Glenosphere Locking Screw. Previously cleared components used with the Central Screw Baseplate System include Peripheral Screws and Glenoid components. The design of the proposed Central Screw Baseplate System is based on the existing foundation and principles of the currently marketed Equinoxe Standard and Small Reverse Baseplates.
The provided text is a 510(k) summary for the Exactech Equinoxe® Central Screw Baseplate System. It describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical testing.
However, it does not contain information about a study proving that the device meets acceptance criteria related to an AI/ML component, human reader performance, or ground truth establishment based on expert consensus, pathology, or outcomes data. The provided document is for a medical implant (shoulder prosthesis) and focuses on mechanical, material, and biocompatibility testing, not software or AI performance.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this document. The prompt asks for information pertaining to a study for an "AI device," which this product is not.
§ 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.”