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HEALIX ADVANCE Knotless anchors:
The DePuy Mitek HEALIX ADVANCE Knotless BR anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair

The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair
• · Foot and Ankle: Lateral Stabilization
• · Foot and Ankle: Medial Stabilization

HEALIX ADVANCE Self-Punching anchors:
The DePuy Mitek HEALIX ADVANCE SP Biocomposite Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair

The DePuy Mitek HEALIX ADVANCE SP PEEK Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair
• · Foot and Ankle: Lateral Stabilization
• · Foot and Ankle: Medial Stabilization

The subject devices of this Special 510(k) are the HEALIX ADVANCE Knotless anchors and HEALIX ADVANCE Self-Punching (SP) anchors.

The HEALIX ADVANCE Knotless Anchor is a one-piece implantable cannulated, threaded anchor designed to secure soft tissue to bone utilizing suture (provided separately). The anchor is preloaded on a disposable inserter shaft with handle, held in place by a #2 ORTHOCORD stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and violet Polydioxanone (PDS). During implantation, the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The anchor is provided preloaded on a single-use driver. The anchor is offered in three sizes: 4.75mm, 5.5mm and 6.5mm. The anchors are available in two materials: Biocryl Rapide® (BR) and Polyetheretherketone (PEEK) materials. The Biocryl Rapide material is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP. The HEALIX ADVANCE KNOTLESS Anchor is provided sterile and is for single use only.

The HEALIX ADVANCE SP Anchor is a two-piece "self-punching" design consisting of a cannulated, threaded anchor and dilator designed to secure soft tissue to bone utilizing suture (provided separately). The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation, the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The HEALIX ADVANCE SP Anchor is offered in three sizes: 4.9mm, 5.5mm and 6.5mm. The anchors are available in two materials: Biocomposite (Biocryl) and Polyetheretherketone (PEEK) material. Biocryl is an absorbable biocomposite of Polylactic Acid (PLA) and Tricalcium Phosphate (TCP). The HEALIX ADVANCE SP Anchor is provided sterile and is for single use only.

The provided text is a 510(k) summary for medical devices, specifically suture anchors. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting on a study designed to establish acceptance criteria for a new device's performance. Therefore, most of the requested information regarding acceptance criteria and performance study details for a new device is not present in this document.

However, I can extract what is available and clarify what is missing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or specific reported device performance in the format usually associated with a clinical or detailed performance study. The "Non-clinical Testing" section broadly states that "Verification activities were performed on the proposed device. Verification included an assessment of fixation strength for proposed indications at T=0 and over the healing period, as well as assessment of insertion force." The "Safety and Performance" section concludes that "Results of the analyses demonstrated that the devices continue to meet established design inputs and corresponding criteria, and that there were no new issues of safety or effectiveness related to device performance."

This suggests that the "acceptance criteria" were the "established design inputs and corresponding criteria" that the devices were verified against, and the "reported device performance" was that they met these criteria. However, no specific metrics, thresholds, or quantitative results are provided in this summary.

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

The document states that "Verification activities were performed on the proposed device," which would constitute the "test set" for these non-clinical tests. However, it does not specify the sample size used for these tests (e.g., how many anchors, how many iterations).

The data provenance is non-clinical/bench testing, likely performed in-house by the manufacturer (DePuy Synthes Mitek Sports Medicine) or a contracted lab. There is no mention of country of origin of data or whether it's retrospective or prospective, as these terms typically apply to human subject studies.

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

This information is not applicable or not provided in this type of submission. The "ground truth" for non-clinical performance tests usually refers to objective measurements and established engineering or biomechanical principles, not expert consensus as would be used in diagnostic imaging or clinical outcome studies.

4. Adjudication Method for the Test Set

This is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) establishing ground truth in subjective assessments, such as interpreting medical images. For non-clinical device performance testing, objective measurements are typically taken, and any discrepancies would be resolved through standard engineering verification and validation protocols, not through expert adjudication in this sense.

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

No MRMC comparative effectiveness study was mentioned or conducted as this is a submission for a physical medical device (suture anchors), not a diagnostic algorithm or a device requiring human interpretation for its primary function.

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

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

7. The Type of Ground Truth Used

For the non-clinical (bench) testing, the "ground truth" would be the objective measurements obtained from testing the fixation strength and insertion force of the anchors, compared against the pre-defined engineering specifications and design inputs. This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this type of non-clinical device performance testing. Training sets are relevant for machine learning algorithms.

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

This is not applicable, as there is no training set for this type of submission.

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The HEALIX ADVANCE KNOTLESS Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair

Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Ligament (LCL), Iliotibial (IT) Band Tenodesis

Foot/Ankle*: Achilles Tendon Repair
*HEALIX ADVANCE KNOTLESS PEEK Anchors only

The HEALIX ADVANCE™ KNOTLESS Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE™ KNOTLESS Anchors are molded from Biocryl Rapide® (BR) and polyetheretherketone (PEEK) materials. The HEALIX ADVANCE™ KNOTLESS Anchor is provided sterile and is for single use only.

The provided text describes a medical device, the HEALIX ADVANCE™ KNOTLESS Anchor, and its substantial equivalence to predicate devices. It focuses on the device's design, materials, and clinical indications for use, as well as the non-clinical testing performed.

However, the document does not contain information related to an AI/ML device. Therefore, I am unable to provide a response to your request, as it specifically asks for acceptance criteria and study details for a device supported by AI/ML.

The text discusses:

• Device Name: HEALIX ADVANCE™ KNOTLESS Anchor
• Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
• Regulatory Class: Class II
• Product Codes: MAI, MBI
• Indications for Use: Reattachment of soft tissue to bone in procedures involving the shoulder (Rotator Cuff, Biceps Tenodesis, Deltoid Repair), knee (Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Ligament (LCL), Iliotibial (IT) Band Tenodesis), and Foot/Ankle (Achilles Tendon Repair - PEEK Anchors only).
• Non-clinical Testing: In-vitro anchor pull out, time zero anchor pull out, torque testing, biological, sterility, packaging, and shelf-life evaluations.

This information pertains to a physical medical implant and its mechanical performance, not to an AI/ML diagnostic or predictive tool.

Ask a specific question about this device