(94 days)
Prophylaxis for Deep Vein Thrombosis (DVT) for use in a clinical setting or in the home.
The Aircast VenaFlow Elite System is a prescription only, intermittent pneumatic compression device designed 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 two different modes for inflation. The system defaults to Standard Operation which inflates the cuffs one leg at a time, alternating between the two legs once every 30 seconds. The cuffs inflate within less than 0.5 seconds. The system has an alternate S Mode which inflates both cuffs at the same time, once every 60 seconds. The cuffs inflate in approximately 10 seconds.
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 provides the user with several cuff type options: calf, thigh and foot as well as combined compression of any combination of two cuffs.
The Aircast VenaFlow Elite System is available in two configurations. The CLINICAL configuration is for medical facilities and offers the full range of accessories including cuffs, varying tube lengths, optional battery and replacement kits. The HOME configuration is for home use and is provided with simplified patient instructions and offers a specific set of accessories limited to calf cuffs and tubing.
The provided document is a 510(k) summary for a medical device (Aircast VenaFlow Elite System). It describes the device, its intended use, and indicates that performance data was collected. However, it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative sense as typically expected for diagnostic or AI-based devices.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes, specifically after a device modification. The performance data mentioned relates to risk assessment, usability, and electrical safety, not clinical efficacy or diagnostic accuracy with specific metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested sections about acceptance criteria, study sample sizes, ground truth, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it describes a different type of evaluation.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in a quantitative table format suitable for performance metrics like sensitivity, specificity, or predictive values. The document states:
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Failure Modes and Effects Analysis (FMEA) | "adequately assess the risks of the device. Known and potential hazards... were evaluated for risk and the severity of the failure effects to the user and probability of occurrence were categorized." |
| Human Factors and Usability | "validated the usability of the Aircast VenaFlow Elite System in the home environment." "substantiates the acceptability of the risks identified during the risk assessment activities." |
| Electrical Safety | "meets Electrical Safety testing according to IEC 60601-1" |
| Electromagnetic Compatibility (EMC) | "meets Electromagnetic Compatibility according to IEC 60601-1-2" |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The FMEA and usability studies are mentioned but no specifics on participant numbers or data collection methods (retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided. The usability study would likely have involved user participants, but they are not described as "experts" establishing a clinical "ground truth" for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This type of study is not applicable and was not done. The Aircast VenaFlow Elite System is an intermittent pneumatic compression device, not an AI-based diagnostic tool. Therefore, there are no "human readers" to improve with "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm, and its performance is inherently human-in-the-loop (the patient and potentially caregivers/clinicians).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety and usability tests mentioned:
- FMEA: Ground truth would be established by risk assessment methodologies and potentially known failure modes of similar devices or components.
- Human Factors and Usability Study: Ground truth would be established by observation of user interaction, user feedback, and comparison against established usability heuristics or safety standards.
- Electrical Safety & EMC: Ground truth is defined by compliance with the referenced IEC standards (IEC 60601-1 and IEC 60601-1-2).
8. The sample size for the training set:
This is not applicable as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable.
§ 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).