(113 days)
The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The ActiveCare+SFT® System is intended for use in:
- Preventing Deep Vein Thrombosis (DVT).
- Enhancing blood circulation.
- Diminishing post-operative pain and swelling.
- Reducing wound-healing time.
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.
- Treatment of chronic venous insufficiency.
- Reducing edema.
The ActiveCare+SFT® is a prescriptive, pneumatic compression system designed to apply sequential compression to the lower limb. The control unit of the ActiveCare+SFT® is light and compact, thus making it a portable ambulant system. The ActiveCare+SFT® provide the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare+SFT® is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.
The foot compression program is intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
Acceptance Criteria and Device Performance Study for ActiveCare+SFT® System (K110159)
The submission for the ActiveCare+SFT® System (K110159) focuses on demonstrating substantial equivalence to a previously cleared device (K060146) with an added software module. Therefore, the acceptance criteria and performance data specifically address the new "Venous Obstruction Detection software module" rather than the core functionality of the compression system itself. As a result, the information provided in the document is limited for a detailed breakdown of acceptance criteria and a comprehensive study that proves all aspects of device performance.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (modifying an already cleared device with a new software module), the "acceptance criteria" appear to be focused on ensuring the new software module does not raise new questions of safety and efficacy and performs as intended. Specific quantitative acceptance criteria are not explicitly stated in the provided text, but rather implied by the overall goal of demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software performs as intended and correlates data to detect possible venous flow obstruction. | "Lab 003 — Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module" was performed. |
| The modified system does not raise any new questions of safety and efficacy. | "A series of performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare+SFT® System does not raise any new questions of safety and efficacy." |
| Compliance with general safety and electromagnetic compatibility standards. | The ActiveCare+SFT® System complies with voluntary standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and ISO 14971. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "clinical comparison in healthy volunteers." However, it does not specify the sample size for this clinical comparison or the "Lab 003" validation study.
- Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "healthy volunteers," implying the study was prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth related to the "Venous Obstruction Detection software module." The nature of the device (a pneumatic compression system) and the added software's function (detecting potential obstruction) suggest that objective physiological measurements might have been used as ground truth rather than expert consensus on image interpretation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a physical compression system with an added software module for detection, not an imaging AI diagnostic aid that would typically involve multiple readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Yes, a standalone performance evaluation of the algorithm was conducted. The "Lab 003 - Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module" explicitly refers to validating the software module itself, implying an evaluation of the algorithm's performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the "Venous Obstruction Detection software module." Given the nature of detecting "venous flow obstruction," it is likely that objective physiological measurements (e.g., Doppler ultrasound, plethysmography, or other forms of vascular assessment) were used to establish the presence or absence of venous obstruction as ground truth in the healthy volunteers, rather than expert consensus on visual assessment or pathology.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set for the "Venous Obstruction Detection software module."
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. Given the validation study involved "healthy volunteers," it's possible that the initial development (training) of the software module might have used data from a different cohort or internally generated data, or a portion of the "healthy volunteers" data was used for development and another for validation.
§ 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).