Search Results

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.

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.

Ask a specific question about this device

The P.F.C. Modular Total Knee System is indicated for use in a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.

This damage may also be the result of trauma or failed prior surgical intervention.

The P.F.C. ® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement.

The P.F.C. Modular Plus Offset Tibial Tray is part of a modular system for use in total knee replacement. The subject device is a titanium tibial tray component, which is designed to accept snap-in tibial inserts in a range of thicknesses and a variety of surface topographies.

The P.F.C. Modular Plus Offset Tibial Tray and its parent device, the P.F.C. Modular Plus Tibial Tray (K923807) have the same keel geometry and adjusted cement pockets that accommodate four screw holes for optional wedge attachment.

The P.F.C. Modular Plus Offset Tibial Tray has been designed with a proximal baseplate offset from the central stem to accommodate patients whose anatomic canal is not centered within the tibia.

This document is a 510(k) summary for a medical device (P.F.C.® Modular Plus Offset Tibial Tray), not a study report for an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable.

Here's an assessment based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document describes a submission for a new medical device, the P.F.C.® Modular Plus Offset Tibial Tray, to demonstrate substantial equivalence to an existing, legally marketed device. It does not present a study with specific acceptance criteria and performance metrics in the way one would for a diagnostic or AI-powered device.

Instead, the "acceptance criteria" are implicitly the requirements for substantial equivalence to predicate devices. The "reported device performance" is not quantified with specific metrics but is stated as being "similar in performance" to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not applicable and not provided in the document. This is a 510(k) submission for a physical medical device, not a data-driven study of an AI/ML product. The "test set" for substantial equivalence primarily involves comparing specifications, performance characteristics (e.g., mechanical testing), and materials to predicate devices, rather than a clinical dataset in the context of an AI study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable and not provided. "Ground truth" in the context of expert consensus on data is relevant for AI/ML performance evaluation. For a physical medical device asserting substantial equivalence, the "ground truth" is established through engineering design, material specifications, and performance testing against industry standards, not typically by expert review of a "test set" in the sense of an AI study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. Adjudication methods are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies and establish a consensus "ground truth." This is not relevant for the type of device and submission described.

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:

This information is not applicable and not provided. This document describes a physical medical implant (a knee replacement component), not an AI-assisted diagnostic tool. Therefore, an MRMC study and
AI-driven improvement are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable and not provided. As explained above, this is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

This information is not applicable in the context of AI/ML validation. For this physical medical device, the "ground truth" for its safety and effectiveness is established through:

• Engineering design principles.
• Material testing (e.g., biocompatibility, mechanical strength as per ASTM F136).
• Performance testing (e.g., wear, fatigue characteristics, likely bench testing according to the FDA "Draft Guidance for the Preparation of Premarket Notifications {510(k)s} for Cemented, Semi-Constrained Total Knee Prostheses").
• Comparison to the established performance and safety profiles of legally marketed predicate devices.

8. The sample size for the training set:

This information is not applicable and not provided. There is no "training set" for this type of device.

9. How the ground truth for the training set was established:

This information is not applicable and not provided. There is no "training set" or corresponding "ground truth" in the context of AI/ML for this device submission.

Ask a specific question about this device