(92 days)
The Grappler Suture Anchor R3FLEX IOL System is intended for the fixation of soft tissue to bone including:
Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC
Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair
Hip: Capsular Repair, Acetabular Labral Repair
The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.
The Grappler Suture Anchor R3FLEX IOL System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in titanium and all-suture and are connected by suture composed of UHMWPE.
This document is an FDA 510(k) clearance letter and summary for a medical device, the Grappler Suture Anchor R3FLEX IOL System. It does not describe an AI/ML powered device, nor does it detail a clinical study with human readers or AI algorithms. The information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in documentation for AI/ML devices or clinical trials, not in a 510(k) summary for a mechanical medical device like a suture anchor system.
Therefore, I cannot provide the requested information from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and performance testing of the physical device components, rather than clinical efficacy or diagnostic accuracy assessments using AI.
Specifically, the "Performance Testing" section states:
"Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. Specifically, an analysis was presented for Suture Abrasion, Dynamic Axial Dissociation Testing and a USP Monograph. The results of this testing demonstrate the subject device is substantially equivalent to the predicate devices. Bacterial endotoxin testing was conducted and the test results meet acceptance criteria of FDA recognized standards."
This indicates physical and material property testing, not a study evaluating human or AI performance.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.