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The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Hip: Capsular repair, acetabular labral repair.

The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is premounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

The provided document is a 510(k) premarket notification for a medical device: Arthrex SwiveLock Anchors. It is primarily focused on demonstrating substantial equivalence to predicate devices for the purpose of a regulatory clearance for an expanded indication (quadriceps tendon repair).

Crucially, this document does not contain information about an AI/ML-driven device or study that would involve acceptance criteria for algorithms, human-in-the-loop performance, or the other specific details requested in your prompt (e.g., sample size for test/training sets, expert consensus, MRMC studies, ground truth establishment methods for AI).

The "Performance Data" section of this 510(k) summary refers to:

• Static pull-out testing of the Arthrex SwiveLock Anchor and a predicate device.
• Cyclic pull-out testing of the subject device after degradation, compared to a non-resorbable predicate.
• Bacterial endotoxin testing (pyrogen limit specifications).

These are biomechanical and biocompatibility tests for a physical implantable device, not performance metrics for an AI algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets acceptance criteria based on this document. The document describes the regulatory submission for a physical medical device (suture anchors) and its associated mechanical and biological performance, not an AI product.

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The MaxBraid BroadBand Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

Both MaxBraid BroadBand and Expressbraid Broadband Suture consist of a stainless steel straight or curved needle attached to a strand 1.25mm flat suture with round USP size 1 suture ends or 1.5mm flat suture with round USP size 2 suture ends in 38″ lengths. MaxBraid Broadband suture is straight with a single crimped needle, whereas the Expressbraid Broadband suture is a looped construct (both ends crimped into a single needle). The MaxBraid BroadBand Sutures are braided, non-absorbable sutures available in an all blue suture [Chromium-cobaltaluminum-oxide

This document, K160854, describes the substantial equivalence determination for the MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture. It does not contain information about an AI-powered device or a study involving human readers and AI assistance. Therefore, it is not possible to answer the questions regarding acceptance criteria, study details, expert involvement, and ground truth establishment from the provided text.

The document primarily focuses on demonstrating that the new suture devices are substantially equivalent to existing predicate devices (ExpressBraid Graft Manipulation and Arthrex Fiber Tape Suture) based on their intended use, indications for use, materials, design features, colorants, sterilization, and performance testing (knot tensile strength, needle attachment, biocompatibility, pyrogenicity, and shelf life).

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The Ventix Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip. Specific indications are:

Shoulder: Bankart repair, SLAP lesion repair, acromio- clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, pectoralis major repair.

Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow: Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction, Lateral epicondylitis repair

Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair, medial patellofemoral ligament (MPFL) repair or reconstruction, quadriceps tendon repair.

Hip: Proximal hamstring repair

The Ventix Suture Anchor is a two-piece design consisting of the vented body and the threaded tip preloaded with suture. The anchor will be offered in three sizes: 3.5mm, 4.75mm, and 5.5mm and is manufactured from polyetheretherketone (PEEK). The Ventix Suture Anchor will be loaded onto a disposable inserter and will be available with #2 MaxBraid or 1.5mm ForceFiber OrthoTape suture.

The provided document is a 510(k) premarket notification for the Ventix Suture Anchor. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and detailed study results for the device's performance against specific metrics.

Therefore, much of the requested information about acceptance criteria, detailed study results, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from this document.

However, I can provide the limited information available regarding performance testing:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document only mentions that non-clinical laboratory testing was performed using the Ventix Suture Anchors and predicate devices for comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical mechanical testing, not a study involving expert assessment of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes non-clinical mechanical testing, not a study involving human readers or subjective assessments.

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

There was no MRMC comparative effectiveness study done. The document explicitly states "Clinical Tests - None provided as a basis for substantial equivalence." The testing described is non-clinical mechanical testing.

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

This information is not applicable. The device is a physical suture anchor, not an algorithm or AI system. The testing described is mechanical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical pull-out strength testing, the "ground truth" would be the measured mechanical pull-out strength values obtained directly from the testing equipment. This is objective data.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI or machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for a physical device.

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