(101 days)
The Catalyst F1x Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
· Severe arthropathy with a grossly deficient rotator cuff;
· Previously failed joint replacement with a grossly deficient rotator cuff;
· Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/or glenoid;
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity
The Catalyst F1x press-fit stems are intended for cementless press-fit applications.
The Catalyst F1x cemented stems are intended for cemented fixation.
The Catalyst F1x stem is compatible with the implants from the R1 Shoulder Systems.
The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in reverse arthroplasty. The stems can be used in conjunction with the Catalyst R1 Reverse Shoulder humeral articulating poly inserts and glenoid implants for use in reverse shoulder arthroplasty.
This submission for the Catalyst F1x Shoulder System consists of proximal bodies, distal stems, locking screws and spacers. The fracture specific proximal bodies have asymmetric, right- and left-sided finned geometry to provide specific locations to reattach the greater and lesser tuberosities for a stable reconstruction of the proximal humerus. The proximal bodies have a porous titanium structure on the bone engaging regions. The distal stems shall be provided in varying diameters to accommodate varying bone geometries. The distal stems will be offered in press-fit and cemented versions. The press-fit distal stems shall have a tapered, splined proximal geometry with an HA (hydroxyapatite) coating. The cemented stems shall have a smooth stem geometry. The proximal bodies and distal stems shall be secured together using a mechanical taper interface that is supplemented with a locking screw. Spacers shall be provided to offer additional options for restoring the appropriate humeral height.
I am sorry, but the provided text is a 510(k) Premarket Notification letter from the FDA regarding a medical device, the "Catalyst F1x Shoulder System." This document does not contain any information about acceptance criteria or a study that proves a device meets specific acceptance criteria, particularly not for AI/Software as a Medical Device (SaMD) performance.
The document states:
- "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst F1x Shoulder System to the predicate devices."
- "The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, as the legally marketed predicate identified in this 510(k) Summary."
This indicates that the submission relied on non-clinical testing (like biocompatibility, fatigue testing, etc.) and comparison to predicate devices, rather than a clinical study evaluating AI performance against acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text, as this information is not present.
§ 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.”