(69 days)
The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema -
- Venous stasis ulcers -
- Venous insufficiency -
- Peripheral edema -
The device is intended for both home and hospital use.
The CircuFlow™ 5150 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow™ 5150 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within in the first chamber can be programmed, with each successive chamber having its pressure be 7% less than the previous chamber.
This document describes the acceptance criteria and the study conducted for the Devon Medical Products, Inc. CircuFlow™ 5150 Sequential Compression Device.
1. Acceptance Criteria and Reported Device Performance:
The provided document lists several performance tests that were conducted. While the acceptance criteria (i.e., the specific thresholds the device needed to meet) are not explicitly stated in numerical terms within the document, the "Reported Device Performance" is implied by the statement "Bench and laboratory testing was performed and assures that the product meets its specifications." This suggests that all tests were passed successfully according to internal specifications.
| List of Performance Tests | Implied Reported Device Performance |
|---|---|
| Pressure Accuracy Test | Met specifications |
| Cycle Time Test | Met specifications |
| Reverse Pressure Test | Met specifications |
| Treat Time Performance | Met specifications |
| Pressure Sensor Calibration Test | Met specifications |
| Sleeve Integrity Test | Met specifications |
| Treat Time Test | Met specifications |
2. Sample Size and Data Provenance for the Test Set:
The document does not explicitly state the sample size used for each performance test. It mentions "Bench and laboratory testing," which typically refers to controlled testing environments rather than clinical trials with human subjects. The data provenance is laboratory-based testing. There is no indication of country of origin of data or whether it was retrospective or prospective in the sense of patient data.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
Not applicable. This device is a medical instrument (sequential compression device), and its performance testing as described focuses on engineering specifications rather than diagnostic interpretation requiring expert human ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As the testing focuses on engineering performance rather than human interpretation, an adjudication method for a test set is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (sequential compression device), not an AI algorithm for diagnostic interpretation. Therefore, assessing how human readers improve with or without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was effectively done. The performance tests described (e.g., Pressure Accuracy Test, Cycle Time Test) assess the device's intrinsic mechanical and electronic performance without human intervention in its operational function beyond initiation and setting parameters (which are part of its intended use). The device is designed to operate independently based on its programming and mechanics to deliver compression therapy.
7. Type of Ground Truth Used:
The ground truth for the performance tests was based on engineering specifications and established measurement standards. For example, the "Pressure Accuracy Test" would likely compare the device's output pressure to a high-precision reference pressure gauge, and "Cycle Time Test" would measure the actual cycle duration against programmed or target times.
8. Sample Size for the Training Set:
Not applicable. This device is a mechanical/electronic medical device, not an AI or machine learning model that requires a training set in the conventional sense. Its "training" is in its design, engineering, and manufacturing processes, rather than data-driven learning.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of an AI/ML model for this device. The device's operational parameters and performance targets are established through engineering design, clinical requirements for such devices, and regulatory standards.
§ 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).