(177 days)
To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.
The ClearMedical/Aircast VenaFlow Cuffs are an accessory device to a VenaFlow System which is used for the prevention of deep vein thrombosis. The VenaFlow Cuff is designed with two inflatable bladders that fill with air to provide compression to the legs and feet. A connector tubing system attaches the Cuff to the pump system. The VenaFlow Cuffs are latex-free, made of a polyester-cotton fabric. They are The vehal low Oulls are latest nos, a proximal and distal bladder and polyethylene tubing with polypropylene luer-lock connectors.
The provided 510(k) summary for the ClearMedical/Aircast VenaFlow Cuffs does not contain specific acceptance criteria or a detailed study proving the device meets numerically defined criteria in the way a modern AI/ML device submission would. This document is a submission from 2002 and relates to a physical medical device (reprocessed compression cuffs), not an AI/ML algorithm.
Therefore, many of the requested points for describing an AI/ML study (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
However, I can extract the information relevant to this specific submission type:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Technological Indicators of Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Infection Control (CleanMedical reprocessed cuffs are "High Level-Disinfected") | ClearMedical's infection control methods meet or exceed the CDC and APIC standards for this class of device. |
| Fit/Attachment | The ClearMedical/Aircast reprocessed VenaFlow Cuffs demonstrated equality in safety and performance compared to the predicate device. |
| Bladder Function | The ClearMedical/Aircast reprocessed VenaFlow Cuffs demonstrated equality in safety and performance compared to the predicate device, containing attached bladders that inflate with air to control circulation of a designated limb. |
| Velcro Adhesion | The ClearMedical/Aircast reprocessed VenaFlow Cuffs demonstrated equality in safety and performance compared to the predicate device. |
| Connector Function | The ClearMedical/Aircast reprocessed VenaFlow Cuffs demonstrated equality in safety and performance compared to the predicate device, utilizing tubing systems that connect to the VenaFlow pump. |
Study Proving Device Meets Acceptance Criteria:
The submission refers to "bench tests and non-clinical performance data" to demonstrate substantial equivalence. These tests focused on the "Technological characteristics" listed above, comparing the reprocessed ClearMedical device to the predicate Aircast VenaFlow Cuffs. The conclusion is that "in all relevant safety and performance indicators the ClearMedical/Aircast VenaFlow Cuffs demonstrates substantial equivalence to the predicate devices."
Regarding AI/ML-specific questions:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study. The data provenance would relate to the specific bench testing environment, not patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The comparison is between a reprocessed device and a new predicate device based on engineering and performance characteristics.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 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 (expert consensus, pathology, outcomes data, etc): The "ground truth" equivalent in this context is the performance of the original (predicate) Aircast VenaFlow Cuffs, against which the reprocessed ClearMedical cuffs were compared via bench testing.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission for reprocessing a physical medical device relies on demonstrating "substantial equivalence" through bench testing against a predicate device across defined technological characteristics, rather than meeting specific quantitative performance metrics derived from an AI/ML algorithm's output on a dataset.
§ 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).