(29 days)
Patients at Risk for DVT:
These include:
a. Major orthopedic procedures e.g. knee surgery
Major abdominal thoracic surgery including urogenital surgery
Neurosurgery, subarachnoid hemorrhage and stroke
Bedridden Medical patients
b. Patients with chronic venous insufficiency
Not Found
The provided document is a 510(k) premarket notification letter for a device called "Pulstar Logix Pump." It primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and administrative information. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
Therefore, I cannot fulfill your request for the specific details outlined concerning acceptance criteria and study findings. The document confirms the device's classification and regulatory path but does not delve into the technical performance studies that meet specific acceptance criteria.
§ 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).