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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:

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.

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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

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.

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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):

Details on the Study (or lack thereof, as per the 510(k) process):

1. 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."

2. 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.

3. 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.

4. 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.

5. 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."

6. 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.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device that requires a training set.

8. 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."

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