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The Q-FIX\ Knotless All-Suture Anchor is intended for use for soft tissue to bone fixation for the following indications:

Shoulder:

• · Bankart lesion repair
• · SLAP lesion repair
• · Acromio-clavicular repair
• · Capsular shift/capsulolabral reconstruction
• · Deltoid repair
• · Rotator cuff tear repair
• · Biceps tenodesis

Foot & Ankle:

• · Medial/Lateral repair and reconstruction
• · Midfoot and forefoot repair
• · Hallux valgus reconstruction
• · Metatarsal ligament/tendon repair or reconstruction
• · Achilles tendon repair

Elbow:

• · Ulnar or radial collateral ligament reconstruction
• · Lateral epicondylitis repair
• · Biceps tendon reattachment

Knee:
· Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament

• · Iliotibial band tenodesis (IBT)
• · Patellar tendon repair
• · Vastus medialis obliquus advancement (VMO)
• · Joint capsule closure

Hip:

· Acetabular labral repair

The Smith & Nephew Q-FIX® Knotless All-Suture Anchor is a fixation device intended to provide fixation of soft tissue to bone. The device consists of an all-suture anchor preloaded with one (1) transfer suture and either one (1) ULTRABRAID® or MINITAPE® suture assembled inside an insertion device. The device is supplied sterile, for single use only.

The 1.8mm implant (all-suture anchor) is made of braided polyester with either one strand of ULTRABRAID® or MINITAPE® suture and one transfer suture pre-loaded. The ULTRABRAID®, MINITAPE®, and transfer sutures are non-absorbable sutures of ultra-high molecular weight polyethylene (UHMWPE). The Q-FIX® Knotless All-Suture Anchor has a knotless suture locking mechanism that provides adjustable one-way tensioning.

The provided text is a 510(k) summary for a medical device (Q-FIX® Knotless All-Suture Anchor). It details the device's characteristics, intended use, and comparison to predicate devices, but does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study.

The "Performance Data" section briefly mentions "Non-clinical bench testing" including "insertion testing, cyclic loading testing, load to pass testing, and knot tensile strength testing." It states that "the device met all required specifications for each test" and "Results for all tests passed." However, it does not provide:

• A table of acceptance criteria and reported device performance for these bench tests. It only states that the device "met all required specifications" and "Results for all tests passed."
• Information related to AI/human reader performance, study design, expert involvement, or ground truth establishment. This type of information is typically found in submissions for AI-enabled medical devices or diagnostic tools where human interpretation or an algorithm's classification performance is being evaluated. The Q-FIX® Knotless All-Suture Anchor is a physical implant, not an AI/diagnostic software.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specific sub-points (1-9), because the provided text describes a physical medical device and not a diagnostic or AI-enabled device requiring such a study. The "performance data" section is about the physical and mechanical properties of the anchor, not clinical diagnostic performance.

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Smith & Nephew ULTRATAPE is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.

Smith & Nephew ULTRATAPE is a non-absorbable, sterile, synthetic surgical suture composed of UHMW (Ultra High Molecular Weight) polyethylene, offered braided, in both blue and a co-braid of blue/ white. ULTRATAPE is flat in shape, and has a width of 2mm, meeting USP tensile strength requirement for size #2 surgical suture. ULTRATAPE does not comply with USP size classifications. When used with various anchoring implants in orthopedic procedures, it secures and holds the reattached tendon to bone.

Here's a summary of the acceptance criteria and study information for the Smith & Nephew ULTRATAPE surgical suture, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the numerical sample size for the mechanical testing. However, it indicates that the testing was conducted "in accordance with USP requirements," which would imply a scientifically sound and sufficient sample for demonstrating compliance.

• Sample size for test set: Not explicitly stated (implied by "in accordance with USP requirements").
• Data provenance: Not explicitly stated (likely laboratory testing conducted by the manufacturer as part of the 510(k) submission process).

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

This information is not applicable to the type of device and study presented. The study involves mechanical testing against a recognized standard (USP), not expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. This was a mechanical test against a technical standard, not a study requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done. This device is a surgical suture, and its performance is evaluated through mechanical testing, not by human readers interpreting images or data.

6. If a Standalone (algorithm only without human-in-the-loop) performance study was done:

Not applicable. This device is a physical medical device (suture), not an algorithm or AI system. Its performance is inherent to its physical properties, not a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this study was the USP standard for Knot Tensile Strength for non-absorbable, #2 size surgical suture. The device's performance was compared directly against this established technical specification.

8. The Sample Size for the Training Set:

Not applicable. There is no AI or machine learning component to this device, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

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