(64 days)
The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:
Reverse application:
- 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 (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.
Hemiarthroplasty/Total application:
- 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 arthroplasty is not acceptable.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).
The Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.
The Zimmer Trabecular Metal™ Reverse Shoulder System is a modular total shoulder prosthesis that was designed specifically to include patients with non-functional rotator cuffs. It was developed to either encompass a traditional shoulder prostheses, a reverse design or be transformed into a hemi-prosthesis depending on clinical cases encountered during the surgical procedure.
The provided document describes the acceptance criteria and a non-clinical study for the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | |
| (Compared to predicate device Zimmer Trabecular Metal™ Reverse Shoulder System, K052906) | Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are as safe and effective as the predicate devices. |
| Similarity in Materials and Processes | |
| (to predicate device K052906) | The subject device is packaged, manufactured, and sterilized using the same or similar materials and processes as the predicate device. |
| Similar Intended Use | |
| (to predicate device K052906) | The subject device also has similar intended use as the predicate device. |
| Similar Fixation Methods | |
| (to predicate device K052906) | The subject device also has similar fixation methods as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of evaluating a medical imaging or AI device. Instead, it refers to non-clinical performance testing. No sample size for a test set (e.g., number of patients or images) is provided, as this is a medical device and not a diagnostic AI system with patient data.
The data provenance is non-clinical testing, meaning it likely involved bench testing, mechanical simulations, and material characterization rather than human subject data. The country of origin for the data is not explicitly stated beyond the submitter's location (Warsaw, IN, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a medical implant system and not an AI-driven diagnostic device evaluated with a test set requiring expert ground truth annotations, this information is not relevant to the described study. The "ground truth" for this type of device would be established by engineering and material science standards for safety and efficacy.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of "ground truth" establishment by experts or adjudication methods in the context of this non-clinical performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this submission (a shoulder implant device).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device (shoulder implant), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm without human-in-the-loop is not relevant. The "standalone performance" of this device would refer to its physical function and integrity, which was assessed through non-clinical testing.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance evaluation is established through engineering standards, material specifications, and biomechanical principles. This includes demonstrating mechanical strength, durability, and biocompatibility that are comparable to or better than the predicate device. The document explicitly states "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are as safe and effective as the predicate devices." This implies that the 'ground truth' for establishing safety and effectiveness relied on established scientific and engineering methodologies for implantable devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI model, this question is not relevant.
§ 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.”