Search Results

For the improvement of blood circulation in the upper and lower extremities to help prevent and reduce complications of poor circulation.

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, and device performance for the Arterialflow System, Model 32A. The document is an FDA 510(k) clearance letter, which primarily deals with the regulatory approval of the device based on its substantial equivalence to a predicate device. It indicates that the device can be legally marketed but does not provide details about performance studies or acceptance criteria that would typically be found in a clinical trial report or a summary of safety and effectiveness data.

Ask a specific question about this device

Prophylaxis for DVT (Deep Vein Thrombosis)

VenaFlow Reusable Calf Aircell

This device is a Class II compression limb sleeve, and the document is a 510(k) premarket notification. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with detailed performance criteria and statistical analyses common for novel high-risk devices or software as a medical device (SaMD).

Therefore, based solely on the provided text, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, and ground truth establishment is not available. The document pertains to the regulatory clearance of a physical medical device, the Aircast VenaFlow System, based on its equivalence to previously marketed devices.

The text does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, provenance, or specific test sets used.
• Information about the number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The FDA's review for this type of device typically focuses on aspects like:

• Intended Use: The indicated use for prophylaxis of DVT is stated.
• Technological Characteristics: How the device functions (e.g., compression) and its materials.
• Performance Data (Bench and/or limited clinical): Often involves testing against recognized standards or comparing performance to the predicate device in a more limited scope than a full clinical trial. However, the details of these tests are not provided in this summary letter.

In summary, the provided document is a regulatory clearance letter, not a detailed study report. It confirms the device's substantial equivalence to a predicate, allowing it to be marketed, but does not offer the granular information requested about specific acceptance criteria and detailed study methodologies.

Ask a specific question about this device

Prophylaxis for Deep Vein Thrombosis (DVT)

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called the "VenaFlow System Model 30A." This type of letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, thereby permitting its market entry.

However, the document does not contain any information about specific acceptance criteria or a study that proves the device meets such criteria.

The 510(k) pathway primarily relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that the new device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. This often involves comparing device specifications, materials, and intended use to a previously cleared device, rather than requiring extensive clinical trials with predefined performance metrics like those for a Premarket Approval (PMA) application or a de novo classification.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter.
2. Sample size used for the test set and the data provenance: No test set information is provided.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document only states the device's name ("VenaFlow System Model 30A"), its indication for use ("Prophylaxis for Deep Vein Thrombosis (DVT)"), and its regulatory class (Class II). It confirms that the FDA reviewed the 510(k) notification and determined substantial equivalence.

Ask a specific question about this device

Same as the predicate device. The cuff is a part of the VenaFlow System. Indication for use is as a prophylaxis for DVT (Deep Vein Thrombosis).

Aircast Venaflow Sterile Disposable Cuff

This is a 510(k) approval letter for a medical device (AIRCAST Sterile VenaFlow™ Disposable Cuff) and does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria. The provided text is a regulatory document confirming substantial equivalence, not a study report.

Therefore, I cannot extract the requested information from the given text. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or details about test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

Ask a specific question about this device

Ask a specific question about this device