(29 days)
The Tornier Perform Reversed Glenospheres are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- · Revision of the devices if sufficient bone stock remains
Notes:
- · All components are single use.
- The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres are part of a reverse shoulder prosthesis consisting of cannulated cobalt chromium and titanium alloy glenospheres. The Tornier Perform Reversed Glenoid Cannulated Glenospheres are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
The Tornier Perform Reversed Glenoid Cannulated Glenospheres must be used in association with a compatible Tornier reversed glenoid and humeral component. The cannulated glenosphere can be used as part of the glenoid implant. The glenoid implant is composed of a baseplate with central and peripheral anchoring screws and a glenosphere. An optional press-fit post is available that can be used in lieu of the central anchoring screw.
Ancillary instruments are also provided for the implantation of the prosthesis.
The provided text describes a 510(k) premarket notification for a medical device, the Tornier Perform™ Reversed Glenoid Cannulated Glenospheres. This document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML powered device.
The document states:
- "Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence to the predicate device."
- "No clinical studies were performed."
Therefore, there is no information available in the provided text to answer the specific questions about acceptance criteria for an AI/ML device, performance studies, sample sizes, expert involvement, or ground truth establishment. The document describes mechanical bench testing (Glenosphere Loosening, Taper Disassembly, Glenosphere Fatigue) and simulated use to demonstrate substantial equivalence to a legally marketed predicate device, K161742.
§ 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.”