(80 days)
The Aevumed RAPID™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral Repair
The Aevumed RAPIDTM Suture Anchor with HS FiberTM suture is a suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed RAPIDTM Suture Anchors are available in diameter sizes: 2.4mm and 3.0mm. They are offered sterile and are for single use only
The provided text is a 510(k) premarket notification for a medical device (Aevumed RAPID™ Suture Anchors). It details the device's characteristics, indications for use, and a comparison to predicate devices, but does not describe a study involving AI or software, nor does it provide acceptance criteria and performance data in the context of an AI/software device evaluation.
Therefore, I cannot extract the information required in your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because the document describes a hardware medical device (suture anchors) and its mechanical testing, not a diagnostic or AI-driven system.
The "Non-clinical Tests" section mentions mechanical testing for pullout strength and states:
- Study: "Both the Aevumed RAPID™ Suture Anchor and predicate SutureTak™ Anchor (K140855) were mechanically tested for maximum pullout strength."
- Result: "The Aevumed RAPID™ Suture Anchor demonstrated significantly higher pullout strength in comparison to the predicate SutureTak™ Anchor (K140855)."
This is the only "performance" information related to a "study" in the document, and it pertains to the physical device's mechanical properties, not an algorithmic 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.