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The LINK Endo-Model Knee System is indicated for patients with diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. This device is intended for cemented use only unless a cementless modular stem is indicated for use. The LINK Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the following conditions:

1. Bone necroses.
2. Bicondylar arthrosis by partly damaged collateral ligaments
3. Revision after primary total knee replacement.
4. Revision surgery after hinge knee or rotational knee joint.
5. Revision surgery by insufficient / inadequate bone mass.
6. Arthrosis of patella flange.
7. Valgus/Varus deformities

This 510k adds Femoral Segments (Augments) made of UHMWPE. The subject femoral segments are available in four heights: size 1 (20mm h), size 2 (25mm h), size 3 (50mm h), and size 4 (80mm h). They are available in right and left versions, and in sizes x-small, small, medium, and large, which correspond to the femoral component sizing. The size 1 and size 2 segments are a unicompartmental design provided either as a set containing one medial and one lateral component, or individually packaged (e.g. only the medial or only the lateral). The size 3 and 4 are a bicompartmental design (do not have medial versus lateral components like the size 1 and 2 variants).

The provided document is a 510(k) summary for a medical device, the LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE. This document is for a medical device clearance and does not contain information about an AI/ML-powered device. Therefore, I cannot extract the specific acceptance criteria and study details as they would be presented for an AI/ML product.

The document discusses the substantial equivalence of the new femoral segments (augments) made of Ultra-High Molecular Weight Polyethylene (UHMWPE) to previously cleared predicate devices. The "performance testing" mentioned refers to engineering comparisons and biocompatibility evaluations, not to the kind of AI/ML performance metrics you've asked for.

Here's why I cannot fulfill your request based on the provided text:

• No AI/ML Component: The device described is a physical knee implant component. There is no mention of artificial intelligence, machine learning, algorithms, or any software that processes data to make predictions or assist human readers.
• Nature of "Performance Testing": The document states "A comparison of designs, materials, purpose, and fixation method was provided to demonstrate substantial equivalence to the predicate femoral augments. An evaluation of the Biocompatibility of the modified device compared to the predicate UHMWPE augments was provided." This indicates that the performance testing was focused on the physical and biological properties of the implant, not on the accuracy or effectiveness of an AI model.
• "Clinical Testing: Clinical performance testing was not required": This explicitly states that clinical studies (which would typically involve test sets, ground truth establishment, expert readers, etc., for AI devices) were not needed for this particular clearance, further confirming the absence of an AI component.

In summary, the provided text describes a traditional medical device clearance process for a knee implant component, not an AI/ML-driven medical device. Therefore, the questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies for AI/ML devices are not applicable to this document.

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