Search Results

The LINK® GEMINI® SL® Total Knee System is indicated for patients suffering from disability due to:

• Degenerative, post-traumatic or rheumatoid arthritis;
• Avascular necrosis of the femoral condyle;
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
• Moderate valgus, varus or flexion deformities.

This device may also be indicated in the salvage of previously failed surgical attempts. The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.

The LINK® GEMINI® SL® Total Knee System is a semi-constrained, patellofemorotibial, cemented knee prosthesis. It is intended to replace the three articular portions of the knee joint. The system compromises two different designs: “Cruciate Retaining (CR) tibial components are made of CoCrMo and are available with PorEx® (K152431) surface modification.

This document is a 510(k) premarket notification for the LINK® GEMINI® SL® Total Knee System. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria that the device proves to meet in a clinical setting.

Therefore, the information you requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial with performance metrics, is largely not applicable in this document. This submission relies on non-clinical performance testing to demonstrate substantial equivalence.

I will address the requested points based on the information provided, explicitly stating when the information is not available or not applicable.

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

This document does not specify "acceptance criteria" in the format of pass/fail metrics for a clinical study. Instead, it relies on demonstrating that the device performs comparably to the predicate device through non-clinical testing. The "reported device performance" is the successful completion of these non-clinical tests.

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 provided in the document. The document refers to "non-clinical performance testing," which typically involves laboratory testing on device components, not human test subjects or retrospective/prospective data from a specific country. Therefore, "sample size for the test set" and "data provenance" as applied to clinical studies are not relevant here.

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 as there was no clinical test set requiring expert ground truth. The evaluation was based on non-clinical engineering and materials testing.

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

This information is not applicable as there was no clinical test set or human interpretation requiring adjudication.

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. The device is a total knee system, not an AI-assisted diagnostic or imaging device. No MRMC study was mentioned or performed.

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

This information is not applicable. The device is a total knee system, not an algorithm or AI system.

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

The "ground truth" in this context is the established scientific and engineering principles and standards (e.g., ISO and ASTM standards) for evaluating the mechanical and material performance of total knee prostheses. The device's performance was compared against these standards and the known performance of the predicate device.

8. The sample size for the training set

This information is not applicable as the document describes a medical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device