(37 days)
VascuComp™ AI Mode: The VascuComp™ compression system in AI Mode is used as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: Minor Amputations, Angioplasty / Stent Failure, Arteriopathic Wounds, Graft Failure, Intermittent Claudication, Ischemia, Night Pain, Rest Pain, Small Vessel Discase, Ulcers. VascuComp™ DVT Mode: Decrease the risk of deep venous thrombosis (DVT). Aids the blood flow back to the heart. Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications. VascuComp™ L Mode: Treatment of Venous disorders and dysfunction of the "muscle pump".
The VascuComp™ device is comprised of a reusable air-pump with user adjustable pressures, and various single-patient sleeves or garments containing discrete, segmental inflatable chambers to be externally applied over the affected extremity of the pationt. The Vascu Comp™ provides calibrated, intermittent, sequential compression.to the treatment site for optimum therapy for patients with ischemic disease of the lower extremities, by increasing arterial circulation, and to reduce the risk of the formation of DVT and to reduce or control peripheral edema. The Vascu Comp™ systems utilize microprocessor control with multiple sensors to ensure patient safety and system functionality, and to provide consistent and repeatable therapy modalities. Alarms are both visual on the unit display and audible. Alarms are in place to detect a potentially unsafe situation and to terminate therapy to protect the patient and the system.
The ThermoTek VascuComp™ is an intermittent, sequential pneumatic compression device. The provided text describes non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical context.
The "acceptance criteria" in this context are the published and observed therapy modalities (pressure levels and cycle times) and safety standards of the predicate devices. The "reported device performance" is the VascuComp™'s ability to match these parameters.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter (Acceptance Criteria Based on Predicate Device) | VascuComp™ Reported Device Performance |
|---|---|
| VascuComp™ AI Mode (Predicate: BioArterial Plus K072666) | |
| Inflation Pressure | |
| Calf | Matches 120 mmHg |
| Foot | Matches 120 mmHg |
| Cycle Time | |
| Compression | Matches 3 seconds (± 0.5 sec) |
| Non-Compression | Matches 17 seconds (± 0.5 sec) |
| Delay between Foot & Calf | Matches 1 second (± 0.5 sec) |
| Total Cycle | Matches 20 seconds / 3 Cycles per minute |
| Electrical Safety | Matches IEC 60601-1, UL60601-1, CAN/CSA 22.2, IEC 60601-1-2 |
| VascuComp™ DVT Mode (Predicate: VascuTherm K061866) | |
| Inflation Pressure | |
| Calf | Matches 45 mmHg |
| Foot | Matches 100 mmHg |
| Cycle Time | |
| Inflation | Matches 30 seconds |
| Deflation | Matches 30 seconds |
| Electrical Safety | Matches IEC 60601-1, UL60601-1, CAN/CSA 22.2, IEC 60601-1-2 |
| VascuComp™ L Mode (Predicate: PBS Model 701A K060220) | |
| Inflation Pressure | Matches 20 to 80 mmHg |
| Electrical Safety | Matches IEC 60601-1, UL60601-1, CAN/CSA 22.2, IEC 60601-1-2 |
| General Safety (IEC 60601-1 & IEC60601-1-2) | Met construction, dielectric testing, electrical leakage, and pre-scan data for conducted and radiated emissions. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing.
- Sample Size: The testing for the pneumatic compression therapy functionality (pressure and cycle times) involved "a minimum of 2 compression cycles" for the L Mode, "a minimum of two compression cycles" for the DVT Mode, and "a minimum of three compression cycles" for the AI Mode.
- Data Provenance: The data is generated from laboratory testing of the VascuComp™ device and its accessories. It is considered prospective in the context of this specific device's evaluation, as the tests were conducted specifically to demonstrate its performance against established predicate device parameters. The country of origin of the data is not specified but is implicitly the location of ThermoTek, Inc. (Flower Mound, Texas).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Experts were not used to establish ground truth for this non-clinical performance test. The "ground truth" (acceptance criteria) was derived from the published and observed therapy modalities and technical specifications/standards of the predicate devices (BioArterial Plus K072666, VascuTherm K061866, and PBS Model 701A K060220).
4. Adjudication Method for the Test Set
No adjudication method was mentioned as this was non-clinical performance testing, not a clinical study involving human assessment or interpretation. The performance was measured against quantitative specifications.
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
No MRMC comparative effectiveness study was done. This device is an intermittent pneumatic compression machine, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone device in the sense that its performance was measured directly based on its outputs (pressure and cycle times). There is no "algorithm only" performance separate from the device's physical operation, as it is a mechanical device, not a software-only product.
7. The Type of Ground Truth Used
The ground truth used was pre-established physical specifications and performance characteristics of legally marketed predicate devices, along with international electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, UL and CAN/CSA equivalents).
8. The Sample Size for the Training Set
There is no "training set" in the context of this device evaluation. The device's operation is based on electromechanical principles, not machine learning or AI that requires a training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).