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This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis. The HLS NOETOS Revision prosthesis is intended for cemented use only.

The HLS NOETOS System is intended for use as a total knee replacement system sacrificing the cruciate ligaments. The HLS NOETOS System provides the flexibility needed to adapt the implant and the therapeutic solution to the patients need. All the type of implants have been designed with the same objectives: to restore the joint line both in flexion and in extension without altering the patellar height, to restore the articular morphology and to preserve bone stock. The design of the implant, particularly the tibial one, guarantees the antero-posterior stability, by a third femoral condyle that engages a specific tibial bearing area during flexion. The HLS NOETOS System - Revision prosthesis consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a patellar implant. The patella can be preserved if it is in good state or resurfaced by the patellar implant. Femoral and tibial augments as well as femoral and tibial extension stems can be added in order to compensate for bone loss.

This is a 510(k) premarket notification for a medical device (HLS NOETOS System - Revision prosthesis), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance (such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable or available in the provided document.

The document describes a traditional medical device (knee joint prosthesis) and its substantial equivalence to predicate devices, which is a regulatory pathway that does not involve the type of performance evaluation typically conducted for AI/ML software.

The provided text focuses on:

• Device Name: HLS NOETOS System - Revision prosthesis
• Submitter: Tornier S.A.
• Classification: Class II medical device (Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis)
• Predicate Devices: PFC Modular Total Knee System (DePuy), NEX-GEN Complete Knee Solution Legacy Constrained Condylar Knee L-CCK (Zimmer), HLS Noetos System (Tornier).
• Device Description: A total knee replacement system consisting of a femoral component, a tibial tray with a polyethylene bearing, and an optional patellar implant, designed to restore joint line, articular morphology, and preserve bone stock.
• Materials: Cobalt-Chromium alloy for femoral part, tibial tray, spacers, stem adaptors, and sleeve.
• Indications for Use: Total knee replacement for relief of pain and disability due to primary/secondary osteoarthritis and rheumatoid arthritis, and revision of knee prosthesis. Intended for cemented use only.
• FDA Decision: Substantial equivalence determination to legally marketed predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information in the format specified, as it pertains to AI/ML device evaluation, which is not relevant to this document.

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This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis. The HLS NOETOS cemented system with fixed tibial bearing is intended for cemented use only.

The HLS NOETOS System is intended for use as a total knee replacement system sacrificing the cruciate ligaments. The HLS NOETOS System provides the flexibility needed to adapt the therapentic solution to the patients need. All the type of implants have been designed with the same objectives: to restore the joint line both in flexion and in extension without altering the patellar height. to restore the articular morphology and to preserve bone stock. The design of the implant, particularly the tibial one, guarantees the antero-posterior stability, by a third femoral condyle that engages a tibial cam during flexion. The HLS NOETOS System consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a polyethylene patella can be preserved if it is in good state or resurfaced by the patellar implant.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

This document is a 510(k) premarket notification for a medical device (HLS NOETOS System). The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its clinical effectiveness through detailed performance studies with acceptance criteria in the way you've outlined.

The key aspects of this document are:

• Device Description: What the HLS NOETOS System is, its components, and materials.
• Intended Use/Indications: The conditions for which the device is designed (e.g., total knee replacement for osteoarthritis).
• Comparison to Predicate Devices: This is the core of the 510(k). The document lists several predicate devices (ROTAGLIDE+, INSALL/BURSTEIN II, PFC Modular Total Knee System, NEX-GEN Complete Knee Solution LPS) and performs a side-by-side comparison of features like materials, fixation methods, indications for use, and compliance with standards. The "SE?" column likely stands for "Substantially Equivalent?".
• FDA Clearance: The letter from the FDA confirms that based on the submitted information, the HLS NOETOS System is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

While the document mentions compliance with ISO standards for materials (e.g., ISO 5832-4 for CoCr, ISO 5834-2 for UHMWPE), these are material specifications, not acceptance criteria for overall device performance in a clinical study.

Therefore, I cannot fill out your table or answer your specific questions about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, or MRMC studies because this information is not present in the provided text. A 510(k) submission typically relies on a comparison to predicate devices, and often the clinical performance data (if any is required beyond equivalence) would be summarized in a much higher-level fashion or referenced rather than detailed in this specific type of public summary.

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