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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.

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

FairFix Extender is intended to be used in association with FairFix Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.

The FairFix Adjustable Button System includes implantable devices indicated for knee ligament (i.e. ACL, PCL) reconstructive surgery for the fixation of tendons and ligaments by means of a suspensory fixation with an adjustable suture loop.

The FairFix Adjustable Button consists of a metal button with a pre-assembled, non-absorbable adjustable suture loop to be coupled with the graft, a pulling suture (blue) to pull the construct through the bone tunnel and a flipping suture (white) to flip the button once the extracortical side has been reached.

The device is provided pre-assembled on a dedicated graft preparation card, aiming to facilitate implant-graft connection.

The FairFix Adjustable Button Extender is intended to be used in association with the FairFix Adjustable Button in case of large tunnel conditions (e.g. cortical blowout, revision cases, full tunnel). It consists of an elongated metal plate with a recess to house the FairFix Adjustable Button and a lateral slot to allow suture passage.

The provided text is a 510(k) Premarket Notification for a medical device called the "FairFix Adjustable Button System." This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a mechanical bone fixation fastener. The performance data presented are for non-clinical studies (e.g., design validation, characterization testing like lengthening under cyclic loading and load to failure, biocompatibility, pyrogenicity), not for a study involving AI/ML performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies for an AI/ML device based on the provided text. The document explicitly states: "No clinical studies were conducted." and there is no mention of an algorithm or AI component.

To answer your request, the input text would need to describe an AI/ML medical device and a study evaluating its performance against acceptance criteria.

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