(63 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 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 text describes a 510(k) premarket notification for the Aircast VenaFlow Elite System, an intermittent pneumatic compression device for DVT prophylaxis. While it lists performance data related to usability and safety, it does not include a study demonstrating the device meets specific acceptance criteria for diagnostic accuracy or clinical effectiveness in the way an AI/ML medical device would.
The "performance data" section focuses on:
- Failure Modes and Effects Analysis (FMEA): Assesses risks related to home use.
- Human Factors and Usability Study: Validates usability in the home environment and substantiates the acceptability of identified risks.
- Electrical Safety Testing (IEC 60601-1) and Electromagnetic Compatibility (IEC 60601-1-2): Confirms adherence to electrical and EMC standards.
Since this device is a physical therapy device and not a diagnostic imaging or AI/ML-driven device, the information requested in your prompt (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable or present in this 510(k) summary.
Therefore, I cannot populate the table or provide answers to most of your specific questions as they pertain to a different type of device evaluation.
However, I can extract what is available about the "acceptance criteria" and "study" as presented in this document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Risk Assessment for Home Use | FMEA conducted to assess known and potential hazards. |
| Usability in Home Environment | Human Factors and Usability Study conducted; results "substantiate the acceptability of the risks identified." |
| Electrical Safety | Meets IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Meets 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)
- Not applicable / Not provided for diagnostic performance. The "Human Factors and Usability Study" would have involved participants, but their number, demographics, or study design details for this usability study are not described in the summary.
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)
- Not applicable. No diagnostic ground truth was established as this is not a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No diagnostic ground truth was established.
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
- Not applicable. This is not an AI-driven device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable (for diagnostic ground truth). For the usability study, "ground truth" would relate to user feedback and observations of user interaction with the device, which informed the validation of risk acceptability.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set.
§ 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).