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APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size in the shoulder, elbow, wrist, hand, knee, and the foot and ankle.

APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as guide pins for insertion of other implants.

The purpose of this submission is to obtain marketing clearance for APTUS® Cannulated Compression Screw, and APTUS® K-Wire System designs to expand the range of Medartis APTUS fixation devices previously cleared in K133460. K110658. K092038 and K202589.

This submission includes for APTUS® Cannulated Compression Screws (non-sterile):

• additional thread lengths for previously cleared thread diameters (2.2 mm, 3.0 mm, and 4.0 mm) - fully threaded screws for two previously cleared thread diameters (2.2 mm and 3.0 mm)

Additionally, the purpose of this submission is to obtain marketing clearance for various APTUS® Kwire designs (non-sterile and sterile) to expand the range of the Medartis APTUS® K-Wire System, previously cleared in K092038, K133460 and K202589, to include longer versions in two (2) diameters (0.8, 1.1 mm). The K-wires are compatible with the subject device cannulated compression screws and APTUS® Cannulated Compression Screws previously cleared in K110658, K133460 and K202589.

All subject device cannulated compression screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum- 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same material for screws previously cleared in K110658, K133460 and K202589.

The subject device K-wires are manufactured from stainless steel conforming to ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673), the same material for K-wires previously cleared in K092038, K133460 and K202589.

The provided text describes a 510(k) premarket notification for a medical device (APTUS Cannulated Compression Screws Line Extension and APTUS K-Wire System Line Extension). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data.

Crucially, this document does NOT contain information about an AI/ML device, nor does it detail acceptance criteria or a study design for evaluating AI/ML performance.

The "Performance Data" section explicitly states: "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Mechanical testing according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, ASTM F1839-08(2021) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments and FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway". Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the predicate devices K202589, K110658 and K963192. Clinical data were not provided in this submission."

Therefore, I cannot extract the information required to answer your specific questions (e.g., acceptance criteria for AI performance, sample size for test sets of an AI, number of experts, MRMC studies, standalone AI performance, ground truth establishment, training set details) because the provided text is for a hardware medical device (screws and K-wires) and does not involve AI or any form of algorithmic performance evaluation with clinical data.

I am unable to provide the requested table and study details because the provided input does not describe an AI/ML medical device or its performance evaluation.

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