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.

FairFix Extender is 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.

Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.

The subject FairFix Adjustable Button System Extension is a Medacta SportsMed devices line extension providing two new implantable fixation devices with an adjustable suture loop used during knee ligament reconstruction surgery for the fixation of the graft by means of an extra cortical suspensory fixation.

Specifically, the current submission includes:

• FairFix AM Adjustable Button, a metal button with a pre-assembled, nonabsorbable . 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; and
• FairFix PSP Adjustable Button, an extra-cortical fixation device pre-assembled with a non-. absorbable adjustable suture loop indicated for the extracortical fixation of the graft on the tibial side.

Both the devices are provided pre-assembled on a dedicated card, aiming to facilitate device handling and connection to the graft.

This document describes the FDA's decision regarding the 510(k) premarket notification for the FairFix AM Adjustable Button and FairFix PSP Adjustable Button. It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested.

The document indicates that Medacta International SA claimed substantial equivalence to predicate devices (FairFix Adjustable Button System, K203259, and M-ARS ACL, K171640) based on technological characteristics and performance data.

Specifically, it states:

• "No clinical studies were conducted."
• "Based on the risk analysis, performance testing was conducted to written protocols." The listed non-clinical studies include:
  • FairFix Design Validation, Cadaver Lab
  • FairFix AM Adjustable Button Mechanical Behavior Validation Rationale
  • FairFix PSP Adjustable Button Mechanical Behavior Validation Rationale
  • MR safety evaluations
  • PYROGENICITY (Bacterial endotoxin test and Pyrogen test)
  • BIOCOMPATIBILITY evaluation
  • SHELF-LIFE evaluation

Without access to the specific "written protocols" and results of these performance tests, it is not possible to extract the requested information in the provided format. The document only confirms that these tests were performed to support substantial equivalence, but not the specific acceptance criteria or detailed results.

Ask a specific question about this device

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.

Ask a specific question about this device

The MectaTap TI Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure: Shoulder: cuff rotator repair and biceps tenodesis.

The MectaTap TI - Suture anchor is an implantable knotted device used for the soft tissues refixation (i.e.: muscles, tendons, ligaments...) composed of a titanium alloy anchoring component preloaded with two Ultra High Molecular Weight PolyEthylene non-absorbable braided sutures and assembled on a disposable inserter.

Due to its specific design, the MectaTap TI - Suture anchor is implanted by tapping on the plastic handle of the inserter: the modularity between the internal eyelet and the external sleeve translates the axial movement of tapping into rotation of the anchor's body into the bone.

The MectaTap TI Suture anchor comes in two different sizes: ø5.0 and ø6.5mm (maximum external diameter) with a fixed length of 15mm, to cover the intended population and bone quality.

The document provided is a 510(k) Premarket Notification from the FDA for a medical device called "MectaTap TI Suture Anchor." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting detailed performance criteria and studies for AI/ML-driven devices or clinical trials that establish detailed efficacy.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML systems is not present in this document.

Instead, the document details physical performance tests (non-clinical studies) to show the device is safe and effective compared to predicate devices. Here's what can be extracted:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported device performance in terms of specific quantitative metrics for AI/ML performance. Instead, it lists non-clinical studies conducted to support substantial equivalence. The "acceptance criteria" are implied to be that the device performs comparably or acceptably based on these physical tests to existing marketed devices.

The reported "performance" is that these tests were conducted according to written protocols and found satisfactory to support the substantial equivalence claim.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of AI/ML or clinical data. The performance claims rely on non-clinical engineering and biological safety tests.

• Design Validation (Wetlab): The protocol A1 (Wetlab) M07.85.003 was used; however, the sample size (number of devices or tests performed) is not specified.
• Impaction Test, Hitting force assessment Workshop, Cyclic and load-to-failure testing, Mechanical Evaluation (FEA): No sample sizes are provided for these tests, nor is the provenance of any data (e.g., country of origin, retrospective/prospective) relevant here as these are physical device tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the provided document. The document pertains to physical device performance and safety, not diagnostic performance where expert ground truth is typically established.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document. Adjudication methods are typically used in clinical or image-based studies to resolve discrepancies in ground truth, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or conducted. The document explicitly states: "No clinical studies were conducted." The device is a physical medical implant, not an AI/ML diagnostic or assistive tool.

6. If a Standalone Study Was Done

The term "standalone" typically refers to the performance of an algorithm without human intervention in AI/ML contexts. In this case, the studies conducted (Design Validation, Mechanical Characterization, Biocompatibility, etc.) assess the physical device's intrinsic properties and performance. These studies are "standalone" in the sense that they evaluate the device itself, not in combination with another technology like AI.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to AI/ML or clinical outcomes is not applicable here. The "ground truth" in this context is based on:

• Engineering standards: Device materials conforming to ASTM and ISO standards.
• Biocompatibility standards: Confirmation that materials have a history of safe use, and specific tests like bacterial endotoxin and pyrogen tests meeting Pharmacopoeia/USP standards.
• Mechanical testing results: Outcomes of cyclic loading, load-to-failure, and impaction tests are compared against established engineering expectations or predicate device performance.
• Sterilization standards: Compliance with ISO standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not an AI/ML model that requires a training set.

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

This information is not applicable. As no training set is involved, there is no ground truth establishment for it.

Ask a specific question about this device