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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

The provided text is a 510(k) summary for the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not contain information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device performance.

Specifically, the document discusses a suture anchor (a physical medical device used in orthopedic surgery), not an image-based AI or algorithm. Therefore, the requested information (acceptance criteria for an AI, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) is not applicable to this document.

The "studies" mentioned in the document are non-clinical physical tests of the suture anchor and suture, such as:

• suture diameter
• knot tensile strength
• suture approximation force
• chemical characterization
• anchor fixation (in-vitro and in-vivo)
• torque testing
• biocompatibility
• sterility
• packaging
• shelf-life
• bacterial endotoxin testing

These tests are to demonstrate the physical properties and safety of the orthopedic implant and suture, not the performance of an AI algorithm.

Therefore, I cannot provide the requested table or details about an AI study based on the provided text.

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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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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

The provided text describes the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture, which is a medical device for soft tissue to bone fixation. However, the document does not contain information about specific acceptance criteria or a dedicated study providing quantitative performance metrics by which the device's performance can be explicitly measured against pre-defined criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture) through non-clinical testing. This type of submission relies on showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA, rather than conducting a de novo study against specific acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document. Below is a summary of what is available and what is not:

HEALIX ADVANCE™ Anchor with DYNACORD™ Suture Device Performance Summary

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified in the document. The non-clinical testing refers to "anchor fixation testing," "in-vitro testing," "torque testing," "suture testing per USP," "suture approximation force testing," and "in-vivo testing," but the number of samples or specimens for each test is not provided.
• Data Provenance: The testing was "performed on the proposed device and/or its predicates." No information on country of origin or whether it was retrospective or prospective is given. Given the nature of mechanical/biocompatibility testing, it would generally be prospective laboratory testing.

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

• Not applicable for this type of submission. This device is a physical implant, and its performance is evaluated through mechanical, chemical, and biological testing, not by expert review of data like in an AI/imaging study. Ground truth is established by standardized testing methods and measurements.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, this device's performance is determined by objective physical and biological tests, not by human expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a physical medical device, not an AI or imaging diagnostic tool. MRMC studies are not relevant for this product.

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

• Not applicable. This phrase typically refers to the performance of an AI algorithm in isolation. This is a physical device, and its performance is assessed directly through non-clinical testing.

7. The Type of Ground Truth Used:

• Objective Test Results / Standardized Measurements: Ground truth for this device's performance is established by the results of various non-clinical tests (e.g., tensile strength in Newtons, torque in Nm, presence/absence of bacterial endotoxins within specified limits, biocompatibility as determined by in-vivo models). These are direct measurements or observations against established material and biological standards (e.g., USP standards).

8. The Sample Size for the Training Set:

• Not applicable. This submission does not involve machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no training set for this device.

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