(58 days)
The DePuy Attune Total Knee System is intended for use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.
A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint.
Femoral Components
The ATTUNE CR and PS Femoral Components are a metal femoral knee component intended for cemented use. The Femoral Component may be used with the native patella or a resurfaced patella. The congruency is variable and optimized throughout the range of motion.
Fixed Bearing (FB) Tibial Base
The ATTUNE FB Tibial Base is designed to utilize a central universal locking mechanism intended for cemented use. The tibial base incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The tibial base fixation surface is textured.
Fixed Bearing (FB) Tibial Insert
The ATTUNE CR and PS FB Tibial Insert is a polyethylene component. The FB Tibial Inserts are secured to the metal FB Tibial Base.
Patella Components
The ATTUNE Medialized Dome Patella and Medialized Anatomic Patella is a polyethylene component. The patellar components are cemented to the native patella and articulate with the trochlear groove and condyles of the Femoral Component.
The subject Attune medialized dome and medialized anatomic patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The articular surface is offset medially proportional to the size of the component.
The provided text does not describe a study involving a device that requires ground truth establishment by experts, adjudication methods, or MRMC studies. The document is an FDA 510(k) clearance letter for a medical device (DePuy ATTUNE™ Total Knee System), which involves demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing.
Therefore, the requested information regarding acceptance criteria for a study proving the device meets the criteria, including details like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth, training set sample size, and ground truth establishment for the training set, is not available in the provided document.
The document focuses on:
- Device Description: A total knee replacement system composed of individually packaged femoral, tibial, and patellar components.
- Reason for 510(k) Submission: Modification of the sterilization dosing method for a subset of the knee implants (Attune Medialized Anatomic and Medialized Dome Patellar components) from a single high dose to two doses (crosslinking and terminal sterilization).
- Substantial Equivalence: Claimed because the change in sterilization method does not impact intended use, performance, safety, effectiveness, biocompatibility, standards compliance, or labeling.
- Performance Data (Non-Clinical): A list of numerous ASTM, ISO, and ANSI AAMI standards that were followed for testing, indicating that evaluations were performed to determine the impact of the split sterilization dose. These tests likely cover aspects like wear, particle characterization, endurance, material properties (density, crystallinity, oxidation, trans-vinylene yield), and tensile properties.
- Clinical Data: Explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence."
In summary, this document is for a medical device seeking 510(k) clearance through non-clinical performance testing, not an AI/software-based device that would typically involve the detailed study design (e.g., ground truth, MRMC) you are asking about.
§ 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.