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The DePuy Attune Total Knee System is intended for cemented use as a total knee replacement system.

Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The subject device is a polyethylene tibial inserts and patella component made from AOX Polyethylene that mates with existing cemented and noncemented femoral and tibial base components

The provided text does not describe an AI medical device or a study involving AI. It is a 510(k) submission for a Total Knee System and specifically concerns an extension of the product's shelf life (from 5 years to 8 years) for certain components made from AOX Polyethylene that are gamma irradiated.

Therefore, I cannot extract information related to:

• Acceptance criteria for an AI device.
• Sample size for a test set or data provenance for an AI study.
• Number of experts for ground truth establishment for an AI study.
• Adjudication method for an AI study.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI.
• Standalone performance for an AI algorithm.
• Type of ground truth for an AI study.
• Sample size for a training set for AI.
• How ground truth for a training set was established for AI.

The document discusses non-clinical testing to support the shelf-life extension, specifically:

• Material Oxidation Index/Resistance Testing (ASTM F2102-17, ASTM F2003)
• Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3, ASTM F1877-05)

It explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patella components and the predicate devices."

In summary, the provided text does not contain the information requested as it pertains to a mechanical medical device (knee implant) and a shelf-life extension, not an AI device or an AI study.

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Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The subject device is an all polyethylene tibia component made from AOX Polyethylene that mates with existing ATTUNE cemented (K101433) and cementless (K140881) femoral components, and existing ATTUNE patella components (K103756).

The document provided is a 510(k) premarket notification for a medical device, the ATTUNE All Polyethylene Tibia, and does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data.

Here's why the requested information cannot be extracted from this document:

• Device Type: The device is a "Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis," which is a physical implant for total knee replacement, not a software or AI/ML-driven device.
• Study Type: The studies mentioned are "non-clinical tests" related to mechanical properties and material performance of the physical implant (e.g., Contact Area/Pressure, Wear, Constraint on tibiofemoral interface, Spine Fatigue, C2 Fixation Testing, Range of Motion, and bacterial endotoxin testing). These are not studies to evaluate AI/ML performance.
• Lack of AI/ML Specifics: There is no mention of AI, machine learning, algorithms, or any form of software performance evaluation.
• Clinical Testing: The document explicitly states: "No clinical testing was conducted to demonstrate substantial equivalence." This further indicates that the type of clinical performance study typically associated with AI/ML device validation (e.g., impact on human readers, standalone performance) was not performed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) submission for a knee implant.

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The ATTUNE Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE total knee replacement system.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant (provided that adequate bone is present).

The ATTUNE Cementless cruciate retaining (CR) and posterior stabilized (PS) femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is porous coated with Porocoat. The porous coated fixation surface comprises: the bone cut surfaces of the anterior flange, anterior chamfer, distal surface, posterior chamfer, posterior condylar resection, as well as the lugs for additional stability. The fixation of the femoral component to the femoral bone is achieved by biologic fixation via ingrowth into the Porocoat porous coating. The ATTUNE femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The ATTUNE Cementless CR Femoral Components are compatible with the ATTUNE CR Fixed Bearing inserts (K101433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE Cementless PS Femoral Components are compatible with the ATTUNE PS Fixed Bearing inserts (K111433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.

This document pertains to the 510(k) premarket notification for the ATTUNE® Knee System-Cementless CR and PS Femoral Components. It describes the device and its substantial equivalence to predicate devices, focusing on the lack of need for new studies rather than describing the acceptance criteria or studies of the device itself.

Based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those acceptance criteria for the ATTUNE® Knee System-Cementless CR and PS Femoral Components.

The document explicitly states:

• "Non-Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices. As the coating for the subject device is identical to that in K062654, the characterization in K062654 also applies to this 510(k)." (Page 6)
• "Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices." (Page 6)

The submission argues for substantial equivalence based on existing predicate devices:

• The ATTUNE Cementless CR and PS Femoral Components are "identical in design to the ATTUNE CR and PS Femoral Components cleared for cemented use only in K101433 and K111433."
• "The Porocoat porous coating of the ATTUNE Cementless CR and PS Femoral Components is identical to the Porocoat porous coating used on the SIGMA CR Porocoat Femoral Components cleared for Cementless use in K062654."

Therefore, I cannot provide the requested information from the given text as it explicitly states that new testing was not performed for this 510(k) submission.

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