(30 days)
The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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
The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is a modular system consisting of a Glenoid Component Assembly and a Humeral Component Assembly for total shoulder arthroplasty. The associated shoulder surgical instruments are intended to facilitate proper implantation of this shoulder system. The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is designed and indicated for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
Unfortunately, I cannot fulfill your request to provide a detailed table of acceptance criteria and reported device performance, information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.
The provided document is a 510(k) summary from the FDA for a medical device (Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid). While it states that non-clinical bench testing and process validations were performed to demonstrate substantial equivalence, it does not include the detailed acceptance criteria or the specific results of these tests.
The document merely states that:
- "The addition of a short Press-fit Post to the Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system meets the device testing acceptance criteria described in the predicate submission (K161742), and is substantially equivalent to predicate long Press-fit Post."
- "Both the short and the long Press-fit Posts can be configured with the Half-Wedge Augment Baseplate and Full-Wedge Augment Baseplate. These configurations meet the appropriate acceptance criteria."
This document focuses on the regulatory clearance process based on substantial equivalence to a predicate device (K161742), rather than a detailed report of the performance study itself. It explicitly states that "Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device."
To obtain the information you're looking for, you would typically need to review the full 510(k) submission (which is much more extensive than this summary) or potentially the predicate device's submission (K161742) if the acceptance criteria are indeed described there.
§ 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.”