(30 days)
The AIROS 8 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.
The AIROS 8 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.
The AIROS 8 system consists of the device and 8-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.
The digitally-controlled device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, and like the predicate, pressure is applied cyclically for a specified period of time, according to the physician's prescription.
The provided text is a 510(k) Premarket Notification from AIROS Medical, Inc. for their AIROS 8 Sequential Compression Device. This document primarily focuses on establishing substantial equivalence to a predicate device (also the AIROS 8, K172779) and discusses the device's indications for use, technological characteristics, and conformity to certain standards.
The document does not describe:
- Acceptance criteria for a specific performance metric of an AI/ML algorithm.
- A study proving the device meets such acceptance criteria.
- Sample sizes for test sets or training sets in the context of AI/ML.
- Data provenance, expert involvement for ground truth, or adjudication methods.
- MRMC comparative effectiveness studies or standalone AI performance.
- Specific types of ground truth used (e.g., pathology, outcomes data).
Instead, the document details "Functional Performance Testing" which includes items like Alarm Testing, LED/LCD Testing, Cycle Time Testing, Pressure Accuracy Testing, etc. These are tests typical for a physical medical device (a sequential compression device), confirming its mechanical and electrical specifications, not the performance of an AI/ML algorithm.
Therefore, I cannot fulfill the request as the provided text does not contain information related to AI/ML acceptance criteria or the study that proves an AI/ML device meets those criteria. The AIROS 8 Sequential Compression Device is a hardware device, not an AI/ML powered one, based on the provided document.
§ 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).