(141 days)
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be cemented in place in the USA.
This new implant device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. The resulting implant, the Trabecular Metal Glenoid, is designed to interface & articulate with Zimmer B/F humeral components. The subject device is available in one thickness option of 5 mm, and the same outer profile options as the B/F all-polyethylene glenoid. The range of outer profile options include 40, 46, and 52 mm round shapes, and 40 by 46 mm, 46 by 52 mm, and 52 by 56 mm oval shapes.
The provided text is a 510(k) Summary for a medical device called "The Trabecular Metal Glenoid." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not a report of a study proving the device meets specific acceptance criteria through clinical trials or performance evaluations against a set threshold.
Therefore, much of the requested information cannot be found in this type of document. Specifically:
- Acceptance criteria and reported device performance: This document asserts "substantial equivalence" based on "similarity in technological characteristics and indications for use" to predicate devices. It does not provide specific acceptance criteria (e.g., a required accuracy, sensitivity, or precision) or report performance metrics against such criteria.
- Sample size and data provenance for a test set: No test set is described. The approval is based on a comparison to existing predicate devices.
- Number of experts and qualifications for ground truth: Not applicable as there is no test set with ground truth established by experts.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or required for a 510(k) submission of this nature.
- Standalone algorithm performance: Not applicable; this is a physical implant, not an algorithm.
- Type of ground truth used: Not applicable as there is no test set for performance evaluation.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document states:
- "Performance data for the UHMPWE and Hedrocel Trabecular Metal interface can be found in Implex MAF #920, and for the articulating surface geometry in K982981." This implies that prior performance data exists for the materials and articulating surface geometry of components similar to those used in the device, likely from studies supporting those specific material clearances or prior device approvals. However, these are references to other documents and not performance data explicitly reported or re-evaluated for this specific 510(k) submission as a study proving acceptance criteria for the whole device.
In summary, this 510(k) is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on presenting a study with specific acceptance criteria, test sets, or ground truth as would be found for a new diagnostic device or AI algorithm.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”