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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

Pulstar Logix Intermittent Pneumatic Compression System

This document is an FDA 510(k) clearance letter for the Pulstar Logix Intermittent Pneumatic Compression System. It does not contain information about a study proving the device meets acceptance criteria, an AI/ML component, or detailed performance data. Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for a study.
• Types of ground truth or training set details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." This indicates the clearance is based on substantial equivalence to existing devices, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria for an AI/ML algorithm.

The "Indications for Use Statement" only lists the medical conditions for which the device is intended. It does not provide any performance data or study results.

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