Search Results

The Lordex Power Traction Unit provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the Lordex Traction Unit, and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is unloading due to distraction and positioning.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a clearance letter from the FDA for a medical device called "Lordex Power Traction Unit," indicating that it has been deemed substantially equivalent to a predicate device.

The letter discusses:

• Trade Name: Lordex Power Traction Unit
• Regulation Number: 21 CFR 890.5900
• Regulation Name: Power traction equipment
• Regulatory Class: II
• Product Code: ITH
• Indications For Use: Relief from pain for patients suffering with low back pain, including pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs.

However, it does not include any of the following:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Information on experts used to establish ground truth or adjudication methods.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information about a standalone algorithm performance study.
• The type of ground truth used in any study.
• Sample size for a training set or how its ground truth was established.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

Ask a specific question about this device