(281 days)
DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
DVT-4000 device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The system consists of the controller, the tubing sets and Non- woven, sleeves. The system offers sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated. The device may be used with anti-coagulant materials or compression stocking to help prevent DVT and PE under a doctor's consultant.
The provided document is a 510(k) premarket notification for a medical device called DVT-4000, an intermittent pneumatic compression (IPC) system. It focuses on demonstrating substantial equivalence to a predicate device (DVT-2600) rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven system.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove a device meets acceptance criteria for an AI/algorithm. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for an AI/algorithm.
- Details on sample size, data provenance, expert ground truth establishment, or adjudication methods for an AI/algorithm test set.
- Information about MRMC studies.
- Data on standalone algorithm performance.
- Type of ground truth used for AI/algorithm.
- Training set details for AI/algorithm.
The "Performance Data" section (Page 13) refers to standard safety, EMC, biocompatibility, and software verification/validation testing, which are typical for traditional medical devices and not specific to the performance validation of an AI/algorithm. The software is noted as "moderate" level of concern, indicating it's likely responsible for controlling the mechanical operation of the IPC system, not for AI-driven diagnostic or treatment decisions.
§ 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).