(84 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; ununited 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 arthoplasty 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 of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.
The Zimmer Trabecular Metal Humeral Stem is intended to be a single use only implant that is used to replace a shoulder joint. This humeral stem uses Trabecular Metal around the proximal part of the stem for biological ingrowth. It also has an anti-rotational fin, a proximal stem collar, suture holes, and a distal fluted stem body. Stems are available in sizes ranging in diameter from 9-18mm and in the lengths of 130mm and 170mm.
The provided text describes a 510(k) premarket notification for the Zimmer Trabecular Metal™ Humeral Stem. This submission aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not to set or meet specific performance acceptance criteria through the kind of study described in the prompt's requested information.
Therefore, the information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable to this 510(k) submission.
A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device through comparisons of:
- Intended use
- Technological characteristics (materials, design, manufacturing processes)
- Performance data (often non-clinical bench testing, but sometimes limited clinical data if necessary to address new questions of safety or effectiveness).
In this specific case, the "Performance Data (Nonclinical and/or Clinical)" section (within {1}) states:
- "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Humeral Stem is as safe and effective as the predicate devices."
This indicates that a study was performed, but its purpose was to support the claim of safety and effectiveness equivalent to the predicate devices, rather than to meet predefined performance acceptance criteria for a novel functionality. Without more details on the non-clinical testing, it's impossible to provide the specific information requested in the prompt.
Summary of available information relevant to "study that proves the device meets the acceptance criteria":
- Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) review, which doesn't typically involve new, device-specific performance acceptance criteria in the way a PMA might. Instead, the "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness. The reported performance from non-clinical testing was that the device is "as safe and effective as the predicate devices."
- Study Type: Non-clinical testing was performed.
- Purpose: To demonstrate substantial equivalence to predicate devices (New Zimmer Shoulder System (Bigliani/Flatow) K982981 and Bio-Modular Shoulder System by Biomet, Inc. K992119).
- Missing Information: The provided text does not contain details about:
- Specific quantitative acceptance criteria.
- The exact nature of the non-clinical tests (e.g., mechanical testing specifications).
- Sample sizes used for testing.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance.
- Type of ground truth used.
- Training set size or ground truth establishment for a training set (as this is non-clinical and not an AI/algorithm-based device).
§ 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.”