(210 days)
The Ventix Knotless Anchor is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/ foot, elbow, and knee. Specific indications as follows:
Shoulder - Bankart repair, SLAP repair, acromio-clavicular separation, rotator cuff repair or capsulolabral reconstruction, biceps tenodesis, and deltoid repair.
Wrist/Hand - Scapholunate ligament reconstruction and ulnar/radial collateral ligament reconstruction.
Ankle/Foot - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, and mid- and forefoot reconstruction.
Elbow - Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction, and lateral epicondylitis repair
Knee - Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, patellar realignment and repair, and Vastus Medialis Obliquus (VMO) Muscle Advancement.
The Ventix Knotless anchors are also indicated for supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.
The Ventix anchor is a two-piece design featuring a winged tip that fits into the anchor body. The anchor body is vented. The Ventix anchors will be offered in two sizes: 4.75mm and 5.5mm and is manufactured from polyetheretherketone (PEEK). The Ventix anchor will be loaded onto a disposable inserter.
The provided text is a 510(k) premarket notification for the Ventix Knotless Anchors. It does not contain information about acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details that would be relevant to an AI/ML medical device.
The document describes a mechanical medical device (surgical anchors) and its substantial equivalence to a predicate device. The performance data discussed is related to the pull-out strength of the anchor, which is a biomechanical characteristic, not an AI/ML performance metric.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies related to an AI/ML device based on the provided text. The information you are asking for is typically found in FDA submissions for AI/ML-powered software as a medical device (SaMD) or AI-augmented medical devices.
§ 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.