(28 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.