(29 days)
The Aircast VenaFlow Elite System is indicated as a prophylaxis for deep vein thrombosis (DVT).
The Aircast VenaFlow Elite System is an intermittent pneumatic compression device that is intended to apply intermittent application of pressure to a patient's calf, thigh or foot for the purpose of assisting blood flow in the veins.
The Aircast VenaFlow Elite System is a prescription only, intermittent pneumatic compression device design to apply rapid inflation with graduated sequential compression to a patient's calf, thigh or foot for the purpose of assisting blood flow in the veins. This rapid inflation and graduated, sequential compression device accelerates venous velocity and enhances fibrinolysis. The Aircast VenaFlow Elite System provides the user with an option of battery operation in addition to operation from the mains power. The Aircast VenaFlow Elite System is easy to use and provided the user with several cuff type options: calf, thigh and foot as well as combined compression of any combination of two cuffs.
The provided text describes a 510(k) submission for the Aircast VenaFlow Elite System and focuses on demonstrating its substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria in a typical standalone performance evaluation.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, expert-established ground truth, sample sizes for test/training sets, and MRMC studies is not available in the provided document. The document primarily focuses on regulatory approval through substantial equivalence.
Here's what can be extracted based on the information given, and where information is missing:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics similar to predicate | "similar to the previously cleared Aircast VenaFlow System" |
| Modes of Operation similar to predicate | "similar to the previously cleared Aircast VenaFlow System" |
| Performance Characteristics similar to predicate | "similar to the previously cleared Aircast VenaFlow System" |
| Intended Use similar to predicate | "similar to the previously cleared Aircast VenaFlow System" |
| Pressure Profile similar to predicate | "The pressure profile of the new Aircast VenaFlow Elite System is similar to the previously cleared Aircast VenaFlow System." |
| Safety and Effectiveness equivalent to predicate | "Test results demonstrate that the new Aircast VenaFlow Elite System performs according to its predetermined specifications in a safe and effective manner." |
| "demonstrates that the modified system is substantially equivalent to the previously cleared device (predicate) and does not raise any new safety or effectiveness issues." | |
| Functionality with optional battery operation (new feature) | "verified through bench testing and validated through clinical analysis" |
| Energy type and design modifications verified and validated | "verified through bench testing and validated through clinical analysis" |
| Software modifications verified and validated | "verified through bench testing and validated through clinical analysis" |
Details on the Study (or lack thereof, as per the 510(k) process):
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "clinical analysis that was performed on healthy volunteers" but does not give a number for participants.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the study was "prospective" to some extent as it involved "healthy volunteers."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. This type of information is typically for studies evaluating diagnostic or predictive algorithms against an expert-established truth. This submission focuses on demonstrating engineering equivalence and clinical performance (e.g., pressure profiles, blood flow assistance) compared to an existing device. The "ground truth" here is the performance of the predicate device and the physiological effects observed in healthy volunteers.
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Adjudication method for the test set:
- Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are relevant for studies where subjective expert interpretation is being formalized for ground truth. This is not the case here.
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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. This device is an intermittent pneumatic compression system for DVT prophylaxis. It is a physical device, not an AI-powered diagnostic or assistive tool, so an MRMC study is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. The "standalone" performance would be its functional operation in delivering compression, which was verified through "bench testing" and "clinical analysis."
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The type of ground truth used:
- For the "clinical analysis": The "ground truth" was likely physiological measurements (e.g., venous velocity, pressure readings) in healthy volunteers, compared against the established performance of the predicate Aircast VenaFlow System, to ensure similar therapeutic effect and safety.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, this question is not relevant.
Summary of the Study per the Document:
The "study" referenced in the 510(k) submission is primarily a comparative engineering and clinical performance assessment against a predicate device, rather than a standalone clinical trial establishing new efficacy. The key components mentioned are:
- Bench Testing: To verify energy type, design, and software modifications.
- Clinical Analysis: Performed on "healthy volunteers" to validate the device's performance, likely by measuring its impact on blood flow or other physiological parameters. This analysis also compared the modified device to the previously cleared Aircast VenaFlow System.
- Purpose: To demonstrate "substantial equivalence" to the predicate, ensuring the new device performs "according to its predetermined specifications in a safe and effective manner" and "does not raise any new safety or effectiveness issues."
§ 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).