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The LINK® Endo-Model® Knee System is indicated for patients with severe joint 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

The LINK® Endo-Model® Knee System is constrained anti-luxation total knee prosthesis. Retaining the low friction principle, the physiological movement of the rotational knee prosthesis is optimal because the pivot point is within the physiological area. Flexion and rotation of the rotational knee prosthesis take place in a cross joint. The LINK® Endo-Model® Knee System consists of Femoral and Tibial Components, Modular Stems, Femoral Segments and Proximal Tibial Spacers and Segments. The modular components are interchangeable allowing for independent positioning. The Modular Stems are available in a variety of diameters and lengths in cemented or cementless version. Special Femoral Segments for revision surgery of resurfacing knee implants and for tumor cases are available in a variety of heights. Proximal Tibial Spacers and Segments are used to act as a spacer for the missing bone where surgical reasons require the removal bone.

The LINK® Endo-Model® Knee System is available in four (4) different knee joint versions:

• Rotating Hinge Knee Standard (Non-Modular) -Version
• Non-Rotating Hinge Knee Standard (Non-Modular) -Version
• Rotating Hinge Knee Modular Version -
• Non-Rotating Hinge Knee Modular Version -

There are two (2) different versions in the application of the knee system: Rotating and Non-Rotating Hinge version. The main design differences between the Rotating and Non-Rotating Hinge version are the two (2) different mechanical connections between the femoral and the tibial component and the consequent movement of these components. These two (2) different connections are necessary because of the different biophysical properties of the human body and the different indications and contraindications for the use of these products.

The LINK® Endo-Model® Knee System is produced of Cobalt Chromium Molybdenum casting alloy (CoCrMo) and Ultra high molecular weight polyethylene (UHMWPE / noncrosslinked). The Modular Stems (cemented) are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials. The Modular Stems (cementless) are made of Titanium-Aluminum-Vanadium alloy (Ti-6A1-4V) materials. Femoral Segments, Proximal Tibial Spacers and Segments are produced of Titanium-Aluminum-Vanadium alloy (Ti-6A1-4V). There are also Proximal Tibial Spacers which were made of Ultra high molecular weight polyethylene (UHMWPE / non-crosslinked). Centralizers and Patella components are made of Ultra high molecular weight polyethylene (UHMWPE / non-crosslinked). All components are sterile and for single use only.

The provided document is a 510(k) premarket notification for a medical device (The LINK® Endo-Model® Knee System, K143179). It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove acceptance criteria for an AI device.

Therefore, most of the requested information regarding AI device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI system is not applicable and not present in this document.

However, I can extract information related to the device's technical specifications and the non-clinical performance testing used to demonstrate its safety and effectiveness, which serves as a form of "acceptance criteria" for this type of medical device in the context of a 510(k) submission.

Here's the closest interpretation of the requested information based on the provided text:

Acceptance Criteria and Study for The LINK® Endo-Model® Knee System

The provided document describes a premarket notification (510(k)) for a knee replacement system, not an AI device. Therefore, the questions regarding AI-specific criteria (like AI performance, ground truth, expert opinions, MRMC studies) are not applicable.

The "acceptance criteria" for a medical device like this, in the context of a 510(k), are typically based on demonstrating substantial equivalence to a predicate device through engineering and performance testing (non-clinical studies), and adherence to relevant standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document mentions "test samples" for the mechanical testing, specifically stating "All Endo-Model® Rotating Hinge Knee System test samples". However, the exact number of samples (the test set size) for each specific test (wear, fatigue, fretting, etc.) is not specified in this document.
• Data Provenance: The testing was non-clinical performance testing, likely conducted by the manufacturer (Waldemar Link GmbH & Co. KG) in Germany, as part of their submission to the FDA. It is not patient data (retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable. The "ground truth" for this type of mechanical device is established through physical engineering tests against established industry standards and specifications (e.g., ISO, ASTM), not through expert clinical consensus or interpretation of patient data.

4. Adjudication Method for the Test Set

This question is not applicable. As the testing is physical mechanical evaluation against defined standards, there is no need for expert adjudication in the way it would be for AI output or clinical data. The "adjudication" is met by verifying test results against numerical or qualitative pass/fail criteria from the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human readers' diagnostic performance, which is not applicable to a knee implant device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone study in the context of an "algorithm only" was not done. This device is a physical implant, not an algorithm. The non-clinical performance tests are "standalone" in the sense that they evaluate the device itself without human interaction beyond its intended use.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering standards and specifications (e.g., ISO 14243-1 and -2, ISO 14879, ASTM F1800, ASTM F1875-98) for mechanical properties, wear resistance, and fatigue strength. It is not clinical expert consensus, pathology, or outcomes data in the context of proving initial device efficacy for market clearance.

8. Sample Size for the Training Set

This question is not applicable. The device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. The device is not an AI algorithm.

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