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The AIROS 8P Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema

The device is safe for both home and hospital use.

AIROS 8P Sequential Compression Device is a pneumatic compression device used for treatment and management of venous or lymphatic disorders. The application of compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The device consists of the mechanical device that is used to set the treatment options and supplies cycles of air to the compression garments. There are three primary treatment modes, Gradient Mode, Pressure Mode, and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the compression garments from the distal to proximal areas of the body. The compression garments are supplied in various sizes for the upper and lower extremity areas of the body.

The provided text is a 510(k) premarket notification for the AIROS 8P Sequential Compression Device. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that a device meets specific performance acceptance criteria for a novel AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria for an AI/ML device, its performance, sample sizes for test and training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document.

This document describes a medical device (a pneumatic compression device) and its functional performance testing (e.g., Error Indicator Testing, Noise Testing, Cycle Time Accuracy, Pressure Time Accuracy, Therapeutic Performance, Therapy Time Accuracy, Garment Integrity). These tests ensure the hardware and software functionality, and compliance with electrical and safety standards, but do not involve an AI/ML algorithm that requires a dedicated clinical or imaging study with a ground truth established by experts.

Here's why the specific questions cannot be answered from the provided text:

• No AI/ML Component: The AIROS 8P Sequential Compression Device is a physical medical device that applies pneumatic compression. The "AIROS" in the name refers to the company, not Artificial Intelligence. The description of the device's operation ("digitally controlled device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve") confirms it's a mechanical device with digital controls, not an AI/ML algorithm that interprets data or images.
• Substantial Equivalence Focus: The entire premise of this 510(k) submission is to demonstrate that the AIROS 8P is "substantially equivalent" to already legally marketed predicate devices (AIROS 8 Sequential Compression Device and Mego Afek Lympha Press Optimal). This type of submission does not typically involve clinical trials or performance studies that would establish acceptance criteria for a novel AI/ML algorithm's accuracy, sensitivity, or specificity.
• Functional Performance Testing: The "Functional Performance Testing" listed (Error Indicator Testing, Noise Testing, Cycle Time Accuracy, etc.) pertains to the engineering and operational parameters of the physical device, not an AI algorithm's diagnostic or predictive performance.

In summary, the provided document does not contain information about acceptance criteria or a study for an AI/ML device because the AIROS 8P Sequential Compression Device is not described as an AI/ML device.

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