(196 days)
The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both. The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as: prevention of deep vein thrombosis (DVT), enhancement of blood circulation, reduction of post-operative pain and swelling, reduction of wound-healing time, stasis dermatitis, treatment and assist healing of cutaneous ulceration, venous stasis ulcers, leg ulcers, chronic venous insufficiencies, reduction of edema.
The ProAir 3000 is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The device is composed of four components: Portable pneumatic control unit, Pair of cuffs (calf and/or foot-ware), Pneumatic connecting tubes, Electrical transformer. During the compression cycle the solenoid valves are activated to insert air into one cuff and then other valves are activated for the other cuff. After inflating the cells in one cuff, the solenoid valves are deactivated and, simultaneously, the second cuff is inflated. Following a complete cycle for both legs there is a relaxation period. A software-based protection limits the pressure in all cuff cells using pressure sensors. In addition, a mechanical valve has been included in the air system for releasing air in case of over pressure in one of the cells. The ProAir 3000 has three operation modes: calf cuff mode, foot cuff mode and combined mode.
The provided text describes a 510(k) submission for the ProAir 3000 Compression System. While it mentions safety and performance testing, it does not provide specific acceptance criteria or the details of a study that proves the device meets them.
The documentation focuses on demonstrating substantial equivalence to predicate devices based on a series of safety and performance testing, but the specifics of what was tested to what standard, and the results, are not included in this document.
Therefore, for your request, I can only state that the detailed information you are asking for is not present in the provided text.
Specifically, the following sections cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set requiring expert ground truth is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not described. This type of study would not typically apply to a compression system anyway; it's more relevant for diagnostic imaging AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm in the traditional AI sense.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as no AI/algorithm training is described.
- How the ground truth for the training set was established: Not applicable.
The document states: "Based on a series of safety and performance testing including a comparative study, Medical Compression Systems (DBN) Ltd. believes that the ProAir 3000 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues." This statement indicates that testing occurred, but the specifics of that testing are omitted from this particular 510(k) summary.
§ 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).