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510(k) Data Aggregation
(28 days)
GRYPHON**®** Anchors with DYNACORD Suture
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.
| Acceptance Criteria Category | Acceptance Criteria (Not Specified) | Reported Device Performance (Not Specified) |
|---|---|---|
| Anchor Fixation Testing | Not explicitly stated (e.g., minimum pull-out strength, maximum displacement) | The document states "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." Specific values not provided. |
| In-vitro Testing | Not explicitly stated | The document states "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." Specific values not provided. |
| Sterility | Meets sterility requirements | "Safety evaluations were conducted to address sterility..." The implication is that it met the criteria. |
| Packaging | Meets packaging requirements | "Safety evaluations were conducted to address packaging..." The implication is that it met the criteria. |
| Shelf-life Testing | Meets shelf-life requirements | "Safety evaluations were conducted to address ... shelf-life testing." The implication is that it met the criteria. |
| Bacterial Endotoxin | Meets endotoxin limits | "Bacterial endotoxin testing has been completed on representative device and results have demonstrated that the proposed devices meet the endotoxin limits." |
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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