(234 days)
The ARTAIRA Arterial Compression Device's is an intermittent pneumatic compression device intended for treatment of patients with the following conditions:
- · Intermittent claudication
- · Rest pain
- Diabetic Foot
- · Ischemic neuritis
- · Arterial ulcers
- · Gangrene
- Poor runoff.
The AIROS ARTAIRA Arterial Compression Device is an intermittent pneumatic compression device intended to increase blood flow and increase circulation in the lower extremities by providing timed compression to the foot/ankle and calf. The device consists of a hard casing with an air pump, a set of air valves, an air reservoir controlled by the device software to deliver a rapid burst of pneumatic pressure to the treatment area. The device connects through air tubing to a pair of compression garments (left and right leg), each with two air chambers: one on the underfoot (Foot/Ankle chamber) and one on the calf area (Calf Chamber). The device can either be used with one garment or two garments. The system is intended to be used primarily at home settings according to a physician-prescribed therapy.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the ARTAIRA Arterial Compression Device. This document does not contain information about the acceptance criteria and study proving device performance as typically understood for AI/ML-driven medical devices.
The listed device, the "ARTAIRA Arterial Compression Device (AACD01)", is an intermittent pneumatic compression device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (ArtAssist Device) based on technological characteristics, functional performance testing of the device hardware (e.g., pressure accuracy, timing accuracy, integrity testing), and adherence to various medical device standards (e.g., ISO, IEC).
There is no mention of an AI/ML component in the device description or the testing conducted. Therefore, the specific questions regarding acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to the information provided in this FDA clearance letter.
The functional performance testing described in the document (User Interface & Error Indicator Testing, Noise Testing, Compression Sequence Timing Accuracy Testing, Pressure Accuracy Testing, Therapy Time Accuracy Testing, Garment Integrity Testing, Air Leakage Testing) relates to the mechanical and software control aspects of a traditional medical device, not an AI/ML algorithm's diagnostic or predictive capabilities.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).