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The ProCinch, QuadCinch Adjustable Loop Device is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

The Riverpoint Medical ProCinch, QuadCinch adjustable button loop is comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate. Additional non-absorbable sutures consisting of UHMWPE, or polyester are looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white) or with trace filaments of blue or green color suture.

For configurations that do not have a titanium plate preattached, a titanium plate component is affixed to the loop during the procedure. For models that come with a preattached titanium plate, the procedure is the same except the titanium plate is passed through the channel. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the femoral channel and secure into place. The UHMWPE is available undyed (white), dyed blue, or with trace filaments of blue or green color suture. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

This FDA 510(k) K240194 submission for the Riverpoint Medical ProCinch, QuadCinch device does not describe an AI/ML powered device or a study involving human readers with or without AI assistance. Therefore, many of the requested criteria related to AI/ML performance and human reader studies are not applicable or cannot be extracted from the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a comparison of technical characteristics for a medical device (adjustable button loop for tissue fixation), not an AI/ML algorithm.

Here's the information that can be extracted based on the provided text, with clarifications where the criteria are not applicable:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

As this submission is for a medical device (ProCinch, QuadCinch Adjustable Button Loop) and not an AI/ML powered diagnostic or assistive device, the "acceptance criteria" and "study" described are primarily focused on demonstrating the device's safety and effectiveness through comparison with a predicate device and adherence to relevant standards for medical devices. The performance data focuses on mechanical testing, sterilization, biocompatibility, and packaging validation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to established standards and comparable performance to the predicate device. The performance reported is that the device met all requirements and performed comparably.

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

The document mentions "cadaveric models" for usability testing and "non-clinical mechanical testing" and "LAL and rabbit pyrogenicity testing." However, specific sample sizes for these tests are not provided in the given text. The provenance includes:

• Cadaveric models: (location not specified, likely lab-based)
• Animal testing: Rabbit pyrogenicity testing (location not specified, likely lab-based)
• Mechanical testing: In-vitro lab testing (location not specified, likely lab-based)

The data is non-clinical and largely prospective in the context of the device's development and testing.

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

This criterion is not applicable as this is not an AI/ML device relying on human expert annotations for ground truth. The "ground truth" for this device's performance is established through physical and chemical testing against recognized standards (e.g., ISO, USP) and comparison to a predicate device.

4. Adjudication Method for the Test Set

This criterion is not applicable as this is not an AI/ML device requiring human expert adjudication of results. Testing is based on objective measurements against established standards.

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 criterion is not applicable. No AI assistance is mentioned or involved with this device.

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

This criterion is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this medical device's performance is established through:

• Adherence to recognized standards: e.g., USP for sutures, ISO 10993 for biocompatibility, ISO 11607 for packaging, EN62366 for usability.
• Empirical mechanical testing: Comparing fixation strength against a predicate device.
• Biological testing: LAL and rabbit pyrogenicity testing.

8. The Sample Size for the Training Set

This criterion is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This criterion is not applicable as this is a physical medical device, not an AI/ML algorithm.

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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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