(31 days)
The Parcus Knotless AP Suture Anchors are indicated for the attachment of soft tissue to bone. This product is intended for the following indications:
| Shoulder | Rotator Cuff Repair, Acromioclavicular Separation Repair,
Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or
Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion
Repair. |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Knee | Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Posterior Oblique Ligament Repair, Extra Capsular
Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and
Tendon Avulsion Repair. |
| Foot/Ankle | Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction,
Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal
Ligament Repair. |
| Elbow | Tennis Elbow Repair, Biceps Tendon Reattachment. |
| Hand/Wrist | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral
Ligament Reconstruction, TFCC. |
The Parcus Knotless AP Suture Anchors consist of ribbed anchor bodies in 2.8mm, 4.5mm, and 5.5mm diameters. The anchor body is comprised of Parcus Medical's Advanced Polymer (AP) which is a formulation of ß-TCP and PLGA that has a proven record as a safe and effective absorbable material that has been used in the industry for over 10 years. This material has been developed such that it will maintain the necessary strength to insert successfully and provide the necessary resistance to pull-out long enough for the body to heal and then, over time, break down, be absorbed into the body and eventually replaced by bone. The presence of the osteoconductive ß-TCP will allow for boney replacement at the insertion site as the anchor is absorbed.
Knotless AP Suture Anchors are provided with a single use suture threader and a single use driver. These devices are individually packaged and provided sterile.
The provided document is a 510(k) premarket notification for a medical device called "Parcus Knotless AP Suture Anchors." It primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, intended use, indications for use, biocompatibility, and mechanical testing.
This document describes a physical medical device (suture anchors) and does NOT contain information about an AI/ML-driven device. Therefore, it is impossible to extract the details requested in points 1-9, which relate specifically to the acceptance criteria and study design for an AI/ML device (e.g., test set sample size, expert ground truth, MRMC studies, standalone performance, training set details).
The "Summary Performance Data" section mentions "pull-out strength and cyclic loading studies" and comparison with "published acceptance criteria," but these are engineering performance metrics for a physical implant, not diagnostic or clinical performance metrics for an AI/ML algorithm.
In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and validation study as typically found in submissions for such technologies.
§ 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.