(89 days)
The Dunamis Suture Anchor suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder (Capsular Stabilization - Bankart Repair, - Anterior Shoulder Instability, - SLAP lesion repairs, - Capsular Shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid Repairs, Rotator Cuff tear repairs, Biceps tenodesis), Elbow, Wrist, and Hand (Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment), Knee (Extra-capsular repairs: - medial collateral ligament, - lateral collateral ligament, - posterior oblique ligament, Patellar realignment and tendon repairs: - vastus medialis obliquous advancement, Iliotibial band tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instablility repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy).
The Dunamis Suture Anchor is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components: Suture Anchor, Teleflex Force Fiber Suture(s), USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene, Inserter tool. The Dunamis Suture Anchor is packaged ready to use condition and provides aseptic O.R delivery. The system is provided complete and is not intended to be used or integrated with other bone anchor fixation implantable devices.
The provided text describes information about the Dunamis Suture Anchor PEEK device, but it does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.
The document is a 510(k) premarket notification acceptance letter and summary for a physical medical device (suture anchor). The performance data mentioned (Axial Pull-Out Strength, Biocompatibility, Sterilization Validation, Ethylene Oxide Residuals, Sterile Barrier Packaging performance, Aging of Sterile Medical Device) are for mechanical and material properties of the suture anchor, not for a software algorithm's performance.
Therefore, I cannot provide the requested information for acceptance criteria and study details for an AI/ML device from the given text.
If you have a document about an AI/ML device, please provide that text, and I will do my best to extract the relevant information.
§ 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.