(181 days)
The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.
The Materialise Shoulder Guide and Models are single use only.
The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:
- Depuy Synthes'
- DJO's
- Smith & Nephew's
- Lima's
- Stryker's .
SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.
Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following:
a software component, branded as SurgiCase Shoulder Planner. This software is . a planning tool used to generate a pre-surgical plan for a specific patient.
Materialise Shoulder Guide and Models, which are a patient-specific quide and . models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific quides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.
I am sorry, but the provided text primarily consists of an FDA 510(k) clearance letter and summary for the Materialise Shoulder System. While it describes the device, its indications for use, and technological characteristics compared to a predicate device, crucial details regarding the acceptance criteria and the study proving the device meets those criteria (such as specific performance metrics, sample sizes for test sets, ground truth establishment, or clinical study designs like MRMC studies) are not present in the provided document.
The "Performance Data (non-clinical)" section briefly mentions software verification and validation, but it does not provide the specific "acceptance criteria" for performance or the details of the "study that proves the device meets the acceptance criteria" in the format requested. It mainly relies on demonstrating substantial equivalence to a predicate device based on similar technology and previous testing.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them using only the information given in the input text. The information required for the table and the detailed study description is simply not provided in this regulatory document.
§ 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.”