(136 days)
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.
The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.
The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
The Arthrex VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.shoulder systems.
The Glenoid IRIS is an instrument system intended for use in total shoulder replacement to facilitate preoperative planning and intraoperative placement of the glenoid implant component.
This bundled submission contains four traditional 510(k) submissions associated with Arthrex Glenoid IRIS. All of the submissions correspond to components of the system that are intended for use together to place the guide pin, and subsequently the glenoid implant, in a total shoulder replacement surgery. All of the components (subject devices in the bundled submissions) of Arthrex Glenoid IRIS are indicated for use with the Arthrex lines of Glenoid implants. We would now like to add the Arthrex Vault Lock glenoid implant to this list of compatible/indicated implant systems.
The provided text describes a 510(k) submission for the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) and associated components. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria. The document primarily focuses on the device's intended use, regulatory classification, and its substantial equivalence to predicate devices, with a brief mention of verification/validation testing.
Therefore, I cannot provide the detailed information requested in the prompt based on the given text. The "SUMMARY OF VERIFICATION/VALIDATION TESTING" section is very high-level and lacks the specifics required to answer your questions.
To answer your questions accurately, I would need a document that describes:
- Specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device.
- Thresholds or targets for these metrics that constitute "acceptance."
- Detailed methodology of studies (e.g., test set demographics, ground truth establishment, reader studies if applicable, statistical analysis).
Without this information, any attempt to populate the requested table or answer the specific questions would be speculative and inaccurate.
§ 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.”