(88 days)
Candidates for total knee replacement include patients with:
- A severely painful and/or severely disabled joint resulting from osteoarthritis, post-● traumatic arthritis, or rheumatoid arthritis
- Moderate valgus, varus, or flexion deformities
- Avascular necrosis of the femoral condyle
- A previous unsuccessful knee replacement, osteotomy, or other knee procedure ●
ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:
- Absence or loss of both cruciate ligaments ●
- Moderate varus-valgus or flexion instability that requires a bearing surface with increased ● constraint in the clinical judgment of the surgeon
- Bone loss that requires supplemental fixation in the clinical judgment of the surgeon
The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.
Any non porous-coated components are intended for cemented use only.
The ATTUNE® Revision Knee System is a total knee replacement prosthesis consisting of various components including ATTUNE REVISION CRS FEMORAL COMPONENTS, ATTUNE REVISION CRS FIXED BEARING INSERTS, ATTUNE REVISION FIXED BEARING TIBIAL BASES, ATTUNE REVISION STEMS, ATTUNE REVISION FEMORAL SLEEVES, ATTUNE REVISION FEMORAL AUGMENTS, ATTUNE REVISION TIBIAL AUGMENTS, and ATTUNE REVISION OFFSET ADAPTOR. These components are made from materials such as cast Co-Cr-Mo alloy, UHMWPE, and Ti-6Al-4V ELI alloy. The system is designed for use in total knee arthroplasty to replace the damaged knee joint articulation.
The provided document is a 510(k) Premarket Notification for a medical device, the ATTUNE® Revision Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets clinical acceptance criteria through a formal clinical study with ground truth and expert consensus. The FDA document explicitly states, “Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Revision Knee System and the predicate devices.”
Therefore, the requested information regarding acceptance criteria, study data, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found in this document.
The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices. Below is a summary of the non-clinical performance information provided.
1. A table of acceptance criteria and the reported device performance:
The document describes functional testing performed in compliance with FDA Guidance for Knee Joint Prostheses. While explicit numerical acceptance criteria values are not provided, the general statement below indicates that the measured performance met the necessary thresholds.
| Test Category | Reported Device Performance |
|---|---|
| Functional/Mechanical Testing (e.g., Fatigue, Constraint, Contact Pressure, Interlock Strength) | The results demonstrated that the subject devices are substantially equivalent to the legally marketed predicate devices for anticipated in-vivo loading via various constraint, contact, wear, and fatigue tests. |
| Biocompatibility Testing | Not explicitly detailed with performance metrics, but the materials (e.g., Co-Cr-Mo alloy, Ti-6Al-4V ELI alloy, UHMWPE) conform to relevant ASTM standards (e.g., ASTM F75, ASTM F136, ASTM F648, ASTM F620, ASTM F1537, ASTM F799), which are accepted standards for biocompatibility in implantable devices. There is no mention of novel materials requiring new biocompatibility testing data. |
| Sterilization & Endotoxin Testing | The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. This document refers to non-clinical, in-vitro mechanical and material testing, not human-subject testing involving datasets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth based on expert review was established in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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. No MRMC comparative effectiveness study was performed or required for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a knee implant, not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" in this context is adherence to established engineering standards (ASTM F75, F136, F648, F620, F1537, F799, ANSI AAMI ST-72:2011) and FDA Guidance for mechanical performance testing for knee prostheses.
8. The sample size for the training set:
Not applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.