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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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The Q-FIX? ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle:

· Medial or lateral instability repairs/reconstructions

· Achilles tendon repairs/reconstructions

The Smith & Nephew Q-FIX® ULTRA All-Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of an all-suture anchor with a preloaded ULTRATAPE® suture assembled inside an insertion device.

The provided text is a 510(k) summary for the Smith & Nephew Q-FIX® ULTRA All-Suture Anchor. This document describes a medical device and its equivalence to existing legally marketed devices, primarily through bench testing. It does not describe an AI/ML powered device, nor does it involve a study with human readers, ground truth establishment, or typical AI acceptance criteria.

Therefore, many of the requested fields cannot be populated as they are not applicable to this type of device submission.

Here's the information that can be extracted, and explanations for why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Non-clinical bench testing was completed on the subject device, and the device met all required specifications for each test. Testing included insertion testing, static fixation testing, cyclic loading testing, and knot tensile strength testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed."

However, the specific numerical acceptance criteria and the quantitative results for each test are not provided in this summary. The summary only states that the device "met all required specifications" and that "Results for all tests passed."

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

This is not applicable as this is a non-clinical bench study on a physical medical device. There is no "test set" in the context of an AI/ML algorithm. The "test set" would refer to the number of physical devices or constructs tested for each bench test. This information is not provided in the summary.

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

Not applicable. There is no "ground truth" to establish for a physical medical device bench test in the context of human expert review. The evaluation criteria are based on engineering specifications and physical measurements.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" required for physical device bench testing in the context of human expert disagreement.

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

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of device, the "ground truth" for performance is based on established engineering principles, material properties, and biomechanical standards against which the device's physical performance is measured.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML powered device. There is no "training set."

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

Not applicable. This is not an AI/ML powered device. There is no "training set" or ground truth in the AI context.

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The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is a sterile, single-use, implant construct. The implants are composed of three components: a Plug type lateral button and a medial button, two stainless steel fixation devices and an ultrahigh molecular weight polyethylene (UHMWPE) suture tape. The suture tape has a one-way sliding knot to facilitate reduction. The kit also contains a polyester suture attached to one of the fixation devices to enable passing the medial button from the lateral side to the medial side and a 3.5 mm drill tip passing pin to enable preparation of the fibula and the tibula and the tibia. The eyelet in the passing pin enables delivery of the medial button from the lateral side.

This document is a 510(k) premarket notification for a medical device called the "INVISIKNOT Ankle Syndesmosis Repair Kit." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

It is crucial to understand that this document describes a traditional medical device (an implantable surgical kit), not an AI/ML-driven device. Therefore, the standard elements requested in the prompt regarding AI/ML device testing (such as acceptance criteria for AI performance metrics, sample sizes for test/training sets for AI, expert adjudication of AI ground truth, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this submission.

The document focuses on the mechanical and biological performance of the physical medical device.

However, I will extract information related to "acceptance criteria" and "proof of meeting criteria" as broadly as possible within the context of this specific, non-AI medical device.

Acceptance Criteria and Study for the INVISIKNOT Ankle Syndesmosis Repair Kit (Non-AI Device)

The "acceptance criteria" and "study proving the device meets criteria" in this 510(k) submission refer to the mechanical performance, material composition, and biological safety of the INVISIKNOT Ankle Syndesmosis Repair Kit, not the performance of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance:

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