(239 days)
The ADVANCE® Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
Porous-coated total knee replacement components are for use without bone cement.
The purpose of this submission is to add patellar components to the ADVANCE® Total Knee System. The design features of the subject patellae are summarized below:
- All-poly patellae manufactured from UHMWPE
- Available in sizes 25-41, single- or tri-peg design
- Metal-backed patellae manufactured from UHMWPE and CoCr alloy
- Available in sizes 29-38, tri-peg design with porous coating
The provided document is a 510(k) Summary for the ADVANCE® Total Knee System, specifically for the addition of new patellar components. It outlines the device's indications for use, description, and claims of substantial equivalence to predicate devices. However, this type of regulatory submission does not typically include detailed acceptance criteria or a dedicated study report with performance metrics in the way a clinical trial or algorithm validation study would.
Here's an analysis based on the information provided, and where the requested details are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the evaluation of the new patellar components through "mechanical testing and engineering analyses." It states a general conclusion rather than specific numerical acceptance criteria and performance data.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Capable of withstanding expected in vivo loading without failure | "A review of these results indicates that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure." |
| Mechanical (static stability, contact area, interface strength) and porous coating characteristics comparable to predicate devices | "The design features and materials of the subject devices are identical to those of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary. The evaluation described involves "mechanical testing and engineering analyses" on the device itself, not a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This is not applicable/not provided as the evaluation is based on mechanical testing and engineering analysis of the device, not a human reader assessment of medical imagery or patient outcomes.
4. Adjudication Method for the Test Set:
This is not applicable/not provided for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
This is not applicable/not provided. The document describes mechanical testing of device components, not a study involving human readers or AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) Was Done:
This is not applicable/not provided. This document pertains to a physical medical device (knee implant components), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the results of standardized mechanical and engineering tests, as well as material characterization, demonstrating that the new patellar components perform equivalently to existing predicate devices and can withstand in vivo conditions. This is a physical/material ground truth, not a clinical one.
8. The Sample Size for the Training Set:
This is not applicable/not provided. There is no "training set" in the context of mechanical device testing.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable/not provided for the same reasons as above.
Summary of Study (Based on Provided Text):
The "study" described in the 510(k) summary is a mechanical and engineering evaluation of new patellar components for the ADVANCE® Total Knee System.
- Objective: To demonstrate that the new patellar components (all-poly and metal-backed) are substantially equivalent to existing predicate devices and are safe and effective for their intended use.
- Methodology:
- Mechanical Testing: Performed on the new patellar components to evaluate:
- Static stability
- Contact area
- Interface strength
- Engineering Analyses: Used to interpret the mechanical testing results and compare them to performance expectations.
- Material Characterization: Fully characterized the porous coating for the metal-backed design and tested its static shear properties.
- Comparison to Predicate Devices: The results of these tests and analyses were used to establish "equivalence" with the design features and materials of the predicate devices (ADVANCE® Total Knee System, AXIOM® Total Knee System).
- Mechanical Testing: Performed on the new patellar components to evaluate:
- Conclusion: The review of these results indicated that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
Key Missing Information (for the requested table structure):
As this is a 510(k) Summary for a physical orthopedic implant, the provided document focuses on demonstrating substantial equivalence through mechanical and material characterization, rather than clinical performance data, AI algorithm validation, or human reader studies. Therefore, many categories in your requested table are not directly applicable or are not detailed in this type of submission. Specific numerical values for the mechanical tests (e.g., specific load tolerances, displacement limits, wear rates) would typically be found in a more detailed test report, but are summarized in the 510(k) for regulatory review.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.