(28 days)
The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The WizAir DVT™ 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 WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVT™ provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot -- single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh -- single or double, and combined compression of any combination of two cuffs. The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a sequential intermittent gradient application of a pressure to a three-celled calf cuff.
The provided text describes the WizAir DVT™ device and its substantial equivalence to a predicate device, focusing on the addition of a "Foot Booster cuff." However, it does not contain detailed information about acceptance criteria or a comprehensive study proving the device meets specific acceptance criteria in the way typically required for AI/algorithm performance. The document is a 510(k) summary for a medical device and primarily addresses substantial equivalence for a hardware modification.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Foot Booster performs according to its specifications | "Testing results showed that the Foot Booster performs according to its specifications in safe and effective manner." (Specific quantitative performance metrics are not provided in this summary.) |
| Similarity of pressure profile | "The pressure profile of the new cuff is similar to that of the A-V Impulse System." (No quantitative comparison or acceptance range given.) |
| Safety and Effectiveness | "The modified WizAir DVT™ System is substantially equivalent to its predicate devices without raising new safety and/or effectiveness issues." (General statement; no specific safety or effectiveness metrics or thresholds are defined as acceptance criteria.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "clinical analysis that was performed on healthy volunteers." The specific number of volunteers is not specified.
- Data Provenance: The study was a "clinical analysis" performed on "healthy volunteers." The country of origin is implicitly Israel, given the applicant's address, but this is not explicitly stated for the study data. The study appears to be prospective as it involved performing clinical analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described is a clinical analysis on healthy volunteers to verify the performance of a pneumatic compression device, not an AI or diagnostic device that typically relies on expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to the type of device and study described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists interpreting images), which is not the case for this pneumatic compression device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the WizAir DVT™. It is a hardware medical device with a software component to control pneumatic compression, not an "algorithm" in the sense of an AI model for diagnosis or prediction. The "performance" refers to the mechanical and physiological effects of the device.
7. The Type of Ground Truth Used
For the clinical analysis, the "ground truth" would likely involve physiological measurements related to blood circulation, pressure, or other relevant health indicators in healthy volunteers, comparing the device's performance to expected physiological responses or the predicate device. However, the specific type of ground truth used (e.g., specific physiological measurements) is not detailed in the document.
8. The Sample Size for the Training Set
This information is not provided and is not applicable as this is not an AI/machine learning device that requires a distinct "training set" in the conventional sense. The "software modification" was verified and validated, but no mention of a training set for an algorithm is made.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for the reasons mentioned above.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical device (pneumatic compression) with a minor modification (Foot Booster cuff). The "study" mentioned is a "clinical analysis...performed on healthy volunteers" and "bench testing" to ensure the new cuff performs "according to its specifications in safe and effective manner" and has a "similar" pressure profile to the predicate. The document doesn't provide the detailed methodological rigor, acceptance criteria, sample sizes, and ground truth establishment typically associated with the evaluation of AI/ML-based diagnostic algorithms.
§ 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).