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The HEALIX TiTM Anchors with DYNACORD™ is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; 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. Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular repair, Acetabular Labral Repair.

The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium material, which is a common material used on existing Depuy Mitek devices. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

This document is a 510(k) premarket notification for a medical device called the HEALIX Ti™ ANCHOR with DYNACORD™. It establishes substantial equivalence to a predicate device, meaning it does not require a new study to prove its safety and effectiveness in the same way a novel device would. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not applicable here.

The provided text focuses on the non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate, rather than a clinical study evaluating the performance of an AI/SaMD.

Here's an analysis based on the provided document:

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

The document describes non-clinical testing, not performance against specific clinical acceptance criteria of an AI/SaMD. The "acceptance criteria" here relate to engineering and material performance for a physical implant.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in terms of number of anchors tested, but general non-clinical testing was conducted.
• Data Provenance: Not applicable in the context of clinical data for AI/SaMD. This refers to lab-based testing of physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not an AI/SaMD and does not involve human expert labeling of data. The "ground truth" for these tests would be the established engineering and materials science standards.

4. Adjudication method for the test set:

• Not applicable for non-clinical engineering tests.

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, not an AI/SaMD.

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

• Not applicable. This is a physical medical device, not an AI/SaMD.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" is defined by established engineering standards, USP specifications for suture materials, and biological safety standards (e.g., ISO standards for biocompatibility, endotoxin limits).

8. The sample size for the training set:

• Not applicable. This is not an AI/SaMD.

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

• Not applicable. This is not an AI/SaMD.

In summary, the provided document is a regulatory submission for a physical medical device (suture anchor) based on demonstrating substantial equivalence to an existing predicate device through non-clinical performance and safety testing, not through clinical trials or evaluations of an AI/SaMD.

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The GRYPHON® BR Anchor with DYNACORD™ Suture is intended for:

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 GRYPHON® PEEK Anchor with DYNACORD™ Suture is intended for:

Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Elbow: Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular Repair, Acetabular Labral Repair.

The GRYPHON® Anchor with DYNACORD™ Suture is a push-in suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The GRYPHON® Anchors with DYNACORD™ Suture are available in absorbable BR and non-absorbable PEEK materials. The GRYPHON® Anchors with DYNACORD™ is provided sterile and is for single use only.

This document is a 510(k) premarket notification for the GRYPHON® Anchors with DYNACORD™ Suture. It establishes substantial equivalence to previously marketed predicate devices and does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance with an AI component cannot be extracted.

However, I can provide the available information from the document related to general non-clinical testing performed on the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "Performance testing included anchor fixation testing and in-vitro testing." However, specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons, or maximum displacement) and the exact reported performance values are not provided in this summary.

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

This information is not provided in the document, as it pertains to an AI/algorithmic study, which is not described here. The non-clinical testing likely refers to engineering and biocompatibility tests, not clinical data sets.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable/provided, as no AI/algorithmic ground truth establishment is described.

4. Adjudication Method:

This information is not applicable/provided, as no AI/algorithmic study with adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. This document describes a medical device (suture anchors), not an AI-assisted diagnostic or treatment planning tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable/provided, as the device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used:

For the non-clinical testing mentioned, the "ground truth" would be established by engineering specifications, material science standards, and biological safety standards (e.g., pass/fail criteria for pull-out strength, acceptable levels of endotoxins). It does not involve "expert consensus, pathology, or outcomes data" in the typical sense of AI studies.

8. Sample Size for the Training Set:

This information is not applicable/provided, as no AI model or training set is described.

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

This information is not applicable/provided, as no AI model or training set is described.

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DYNACORD™ suture is indicated for orthopedic procedural use in soft-tissue approximation, and/or ligation, including use with allograft tissue.

DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™ Suture has a double sheath and core design, and contains Ultra High Molecular Weight Polyethylene, Polyester and a Silicone/NaCl core.

The provided text describes a 510(k) premarket notification for the DYNACORD™ Suture, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria were met for an AI device.

The document is for a non-AI medical device (surgical suture) and therefore does not discuss AI-specific metrics like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC comparative effectiveness studies (which are relevant to AI's impact on human readers).

However, I can extract the information that is present regarding the non-clinical testing performed for this suture, which serves as its performance and safety evaluation.

Here's the information I can provide based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Performance testing included: USP Diameter (DYNACORD™ is oversized), USP Knot Tensile Strength, USP Needle Attachment, in-vitro approximation force over time, GLP in-vivo efficacy evaluation. Safety testing included: biocompatibility, sterility, shelf-life, GLP in-vivo evaluation of DYNACORD™ safety. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits."

The conclusion is: "Results of non-clinical testing have demonstrated that the proposed devices are suitable for their intended use."

Regarding AI-specific questions:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for this device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or reference standards would be established by the standardized methods for each test (e.g., USP monographs for suture properties, recognized biocompatibility standards, sterility testing protocols, in-vivo animal model observations for efficacy and safety).
• 8. The sample size for the training set: Not applicable. This is not an AI device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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