Search Results

FairFix Adjustable Buttons are intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.

FarFix Extenders are intended to be used in association with any FairFix Adjustable Button configuration during a knee ligament (i.e. anterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.

The FairFix Adjustable Button Extender Round implants are a Medacta SportsMed devices line extension providing alternative implantable fixation devices to be used during knee ligament reconstruction surgery for the fixation of the graft in association with the FairFix Adjustable Buttons (cleared within K203259 and K221389) in case of large tunnel conditions (e.g. cortical blowout, revision cases, full tunnel).

The subject FairFix Adjustable Button System implants are available in three different sizes and they consist of a circular metal plate provided with a recess specifically designed to house the FairFix Adjustable Button.

The provided document is a 510(k) summary for a medical device (FairFix Adjustable Button System) and does not describe a study involving an AI/Machine Learning device or a diagnostic accuracy study. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study design, expert involvement, ground truth establishment, or sample sizes related to AI device performance.

The document states:

• "No clinical studies were conducted."
• The performance data provided is based on non-clinical studies (mechanical testing, pyrogenicity, biocompatibility, shelf-life evaluation).
• The substantial equivalence claim is based on technological characteristics and performance data, not on human reader performance or AI system accuracy.

Without information about an AI/ML device or a study involving human readers and AI assistance, it is impossible to fulfill your request for details on:

1. Acceptance criteria and device performance table.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study and effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Training set sample size.
9. How ground truth for the training set was established.

Ask a specific question about this device