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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair.

The Healix Advance" Anchor with Permacord™ suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. Healix Advance Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is a non-absorbable suture that conforms to USP, except for oversized diameter. Healix Advance Anchors with Permacord are provided sterile and is for single use only.

The provided text describes the Healix Advance™ Anchor with Permacord™ suture and its substantial equivalence to predicate devices, but it does not detail specific acceptance criteria or a study proving the device meets those criteria in the typical format you've requested for AI/software-based medical devices.

Instead, the submission focuses on demonstrating safety and effectiveness through substantial equivalence to already legally marketed devices, which is a common pathway for predicate-based medical devices. The "study" here refers to non-clinical testing performed to show that the new device performs comparably to its predicates.

Here's an interpretation based on the provided text, formatted to align with your request where possible, but with clear indications where the information is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Verification activities were performed on the implant and / or its predicates" and "Testing assessments include pull out testing, insertion and failure torque, in-vitro testing and suture testing per USP." This implies engineering bench testing, which would involve a certain number of samples, but the exact count is not provided.
• Data Provenance: The testing appears to be internal lab testing ("Verification activities were performed"), not necessarily in a country of origin context. It is non-clinical/bench testing. It is retrospective in the sense that it's evaluating a final design against pre-defined performance metrics, but the data itself is generated prospectively for the submission.

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

• Not applicable. This is a medical device for physical implantation, not an AI/software device that requires human expert review for "ground truth" labels. The "ground truth" for this device's performance is established by engineering specifications and material standards (like USP) as well as the performance of predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. As this is not an AI/software device requiring human judgment for data labeling, there is no adjudication method in the context described. Performance is measured against engineering and material specifications.

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 a physical medical device (suture anchor), not an AI system.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• For this type of device, the "ground truth" is defined by:
  • Engineering Specifications: Specific quantifiable values for pull-out strength, torque, etc.
  • Material Specifications: Adherence to established standards such as USP (United States Pharmacopeia) for sutures.
  • Predicate Device Performance: The demonstrated safe and effective performance of the predicate devices. The new device is shown to be substantially equivalent to these devices.

8. The Sample Size for the Training Set

• Not applicable. This product 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

• Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.

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Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction:
Hip: Capsular repair, Acetabular Labral Repair.

The HEALIX ADVANCE BR Anchor is absorbable threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. The suture options may include needles to facilitate suture passage through tissue. HEALIX ADVANCE BR Anchor is provided sterile and is for single patient use only.

The provided document describes a medical device, the HEALIX ADVANCE™ BR Anchor, and its substantial equivalence to previously marketed predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic or AI-based device.

This document is a 510(k) summary for a bone anchor, which is a physical medical device (implant) used for fixation of soft tissue to bone. The "Safety and Performance" section states: "Design verification activities, such as Anchor Torque, Anchor Pull Out (at T=0 and in vitro testing throughout the healing period) were performed against pre-defined acceptance criteria according to the intended use. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."

This indicates that mechanical performance testing was done for the physical implant, but the details of the acceptance criteria, specific study results, sample sizes for these tests, or any form of "ground truth" or expert adjudication are not included in this regulatory summary. These details would typically be found in the full 510(k) submission or design verification reports, which are not provided here.

Therefore, I cannot fulfill the request as it pertains to acceptance criteria and a study proving a diagnostic device's performance, an AI-based device's performance, or a multi-reader multi-case (MRMC) comparative effectiveness study. The request's questions are geared towards the evaluation of diagnostic algorithms or software, which is not the subject of this document.

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