(86 days)
Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. For cemented use only.
The ADVANCE® Modular Tibial Component is part of the ADVANCE® Total Knee System, a total knee replacement system consisting of femoral, tibial, and patellar components. The ADVANCE® Modular Tibial Component is a modular component consisting of a tibial base, optional tibial augments, and optional stem extensions, all manufactured from titanium alloy. The base is offered both nonporous and porous coated, and features screw holes for optional fixation of the augments or for screw fixation. The base is designed for use with the ADVANCE® tibial inserts and the ADVANCE® femoral and patellar components cleared in previous premarket notifications. All components are intended to be used only with bone cement.
The ADVANCE® Modular Tibial Component is a medical device for knee arthroplasty. The provided text outlines the acceptance criteria and the studies conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cyclic Fatigue Testing | Withstand at least 2.2 x body weight at 10 million cycles (ASTM F04.22.12) | Porous and nonporous titanium tibial bases demonstrated the ability to withstand at least 2.2 x body weight at 10 million cycles under test conditions. |
| Fatigue Testing | Withstand loads of up to 492 pounds for 1 million cycles (ASTM F04.22.01) | Results demonstrate the assembly's ability to withstand loads of up to 492 pounds for 1 million cycles. |
| Axial Distraction Testing | Demonstrate adequate results under extreme conditions | Testing demonstrates adequate results under extreme conditions. Testing confirms the taper connection's integrity. |
| Static Shear Strength | Adequate (ASTM F-1044) | Results from testing performed according to ASTM F-1044 demonstrate that the static shear strength of the porous coating is adequate. |
| Porous Coating Morphology | Distance between particles and mean intercept length in the range of 50 to 114 microns (suggested as optimum for bone ingrowth by Bobyn, et al.) | Stereological evaluation of the porous coating demonstrates that the distance between particles and mean intercept length measured are in the range of 50 to 114 microns suggested as optimum for bone ingrowth by Bobyn, et al. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for cyclic fatigue). The data provenance is from retrospective laboratory testing performed by Wright Medical Technology, Inc., for regulatory submission in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device's performance is established through physical and mechanical engineering tests against pre-defined ASTM standards and scientific literature (e.g., Bobyn, et al. for porous coating). Expert clinical judgment is not directly used to establish the "ground truth" for these performance metrics, but rather to define the standards themselves.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving interpretation by multiple human readers (e.g., radiologists). The performance of this device is assessed through objective, quantitative, and standardized engineering tests, not subjective interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (implantable component), not an AI diagnostic or assistive technology. MRMC studies are not relevant to its type of assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and manufacture, not an algorithmic output.
7. The type of ground truth used
The ground truth used for evaluating the ADVANCE® Modular Tibial Component is based on established engineering and material science standards (ASTM standards) and scientific literature (e.g., research by Bobyn, et al. on bone ingrowth). These standards define the acceptable performance parameters for the device's mechanical integrity and biological interaction (porous coating).
8. The sample size for the training set
Not applicable. This device is not an AI model requiring a training set. The "training" in this context would be the iterative design and development process, which is not quantified by a "sample size" in the same way an AI model's training data is.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI device. The "ground truth" for the device's design and manufacturing specifications would be established through a combination of engineering principles, biomechanical analysis, clinical needs assessment, and adherence to industry regulations and standards.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.