(30 days)
The AIROS 6 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 6 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 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.
The provided FDA 510(k) summary for the AIROS 6 Sequential Compression Device does not include a study proving device performance against detailed acceptance criteria in the manner typically seen for AI/ML-based diagnostic devices. This document is for a Class II medical device (compressible limb sleeve), which is a mechanical device, not an AI or imaging diagnostic tool. Therefore, the questions related to AI/ML specific aspects (such as AI assistance, human-in-the-loop, training/test set details, expert ground truth, effect size, etc.) are not applicable to this submission.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AIROS 6 Sequential Compression Device K172770 from the same manufacturer) through functional performance testing and adherence to relevant standards.
Here's an analysis based on the provided text, primarily addressing the "functional performance testing" section:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "functional performance testing" categories but does not provide specific numerical acceptance criteria or detailed reported performance values. It states: "Testing was performed and to ensure that the system meets its specifications." This implies that the device did meet its internal specifications, but these specs are not detailed in the public 510(k) summary.
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Alarm Testing | Alarms function correctly per specifications. | Meets specifications (passed). |
| LED/LCD Testing | LEDs/LCDs function correctly per specifications. | Meets specifications (passed). |
| Cycle Time Testing | Cycle times are accurate per specifications. | Meets specifications (passed). |
| Pressure Accuracy Testing | Pressure output is accurate per specifications. | Meets specifications (passed). |
| Therapy Time Testing | Therapy duration is accurate per specifications. | Meets specifications (passed). |
| Therapeutic Performance Testing | Device performs intended therapeutic function. | Meets specifications (passed). |
| Garment Integrity Testing | Garments maintain integrity under normal use. | Meets specifications (passed). |
| Pull Testing | Connections/components withstand specified pull forces. | Meets specifications (passed). |
| Garment Printing Testing | Garment markings/printing are durable and legible. | Meets specifications (passed). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the testing involves the physical device and garments, not a dataset in the context of AI/ML. The "test set" would be the manufactured devices and accompanying garments. The provenance would be the manufacturing site of AIROS Medical, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. "Ground truth" in this context refers to the device's functional specifications, which are established by the manufacturer through engineering design and regulatory requirements, not by external experts adjudicating data.
4. Adjudication Method for the Test Set
Not applicable. The testing appears to be functional and engineering validation, not consensus-based adjudication of interpretations of clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical sequential compression device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no AI algorithm in this device.
7. The Type of Ground Truth Used
The ground truth is the device's design specifications and functional requirements as established by the manufacturer and validated through engineering tests.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
§ 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).