(54 days)
When applied by a trained health care professional, the TZ Medical ARC™ device is indicated to assist in controlled compression hemostasis of the radial artery after a transradial procedure; the device is indicated to compress the radial artery access puncture site in order to achieve hemostasis and maintain patency of the radial artery (patent hemostasis).
The TZ Medial ARC Adjustable Radial Cuff "ARC" compression device is used at the end of a Transradial catheterization procedures to provide hemostasis of the radial artery at the access site. The ridged brace designed radial compression device consisting of a rigid polycarbonate "C" shaped brace, a flexible strap containing a PVC backing, hook and loop fasteners, and two buckles which attach to the ends of the brace, a collapsible bubble fixed to an adjustable slider with an air fill tube and universal luer lock, as well as back pad opposite of the bubble for patient comfort. Each device also includes a standard 20cc male luer locking syringe.
The Cuff is positioned around the patient's wrist and secured in place by fastening and tightening the Back Hook and Strap Assembly. As the introducer sheath is removed from the patient's wrist, pressure is applied to the access site by inflating the compression bubble of the ARC device. The bubble is inflated when air is injected through a luer lock air injection port which assures the desired air volume/pressure remains in the compression bubble. The volume/pressure in the bubble can be titrated by the physician to meet the hemodynamic needs of the patient by increasing or decreasing the volume in the ARC device bubble.
The ARC devices is intended for a single use only with a Functional life is less than 24 hours. This device is individually packaged and sterilized by ethylene oxide gas.
The provided text describes a 510(k) premarket notification for the "ARC Adjustable Radial Cuff Compression Device." This document outlines the device's indications for use, its comparison to a predicate device (Terumo TR Band), and mentions performance testing conducted to verify conformity to applicable standards. However, it does not describe a study that involves an AI/ML device, nor does it contain information related to acceptance criteria or performance metrics such as those typically found in clinical trials for diagnostic or AI-assisted devices (e.g., sensitivity, specificity, AUC).
The document primarily focuses on demonstrating substantial equivalence to a predicate device for a physical medical device (a vascular clamp/compression device). The "Performance Testing" section (M) refers to verification of conformity to external and internal standards (e.g., ISO standards for biological evaluation, risk management, sterilization, quality management, packaging). It also mentions Design Verification (DV) functional performance testing which included in-vitro engineering and bench testing on components.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets those criteria, as the provided text does not pertain to such a device or study.
If you have a different document or context related to an AI/ML medical device, please provide it, and I will do my best to answer your detailed questions.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).