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The SpineRx - LDM, Lumbar Decompression Machine, is intended to provide a variety of treatment options for patients who suffer from some of the most common forms of low back pain. Conditions which may be treated include bulging or protruding discs, herniated discs, degenerative disc disease, posterior facet syndrome and sciatica. The SpineRx - LDM can apply therapeutic decompression (distraction) force to relieve pressure on structures which may produce pain. Decompression can relieve pain by introducing a distraction force (unloading) sufficient to reduce intradiscal pressure and impingement. Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions. Variable angle positioning in either supine or prone modalities acts to concentrate decompression forces for optimum results. This machine is a prescription device and as such, it should be used under the direct supervision of a qualified medical professional.

The SpineRx - LDM (lumbar decompression machine) combines proven characteristics of several predicate devices. The SpineRx - LDM provides variable angle decompression (distraction) in either prone or supine modality. The broad range of patient positioning variables allows either straight-line (linear) or angled (curvilinear) decompression (distraction) to be concentrated in more specific spinal segments. The harness and restraint system allows safe, effective application of therapeutic traction. The SpineRx - LDM traction device allows a wide range of selectable functions, force levels and time cycles. Prescribed treatment parameters are selected for each patient and each treatment session.

The provided text is a 510(k) summary for the SpineRx - LDM (lumbar decompression machine). It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and safety features.

Crucially, the document explicitly states: "Formal testing and evaluation have not been performed for the SpineRx - LDM, as of yet." and "Even though we have built two prototype machines, we have not actually built the machine which is the subject of this application. Therefore, we have not conducted tests which demonstrate conformance with applicable standards."

This clearly indicates that no studies proving the device meets acceptance criteria have been conducted or reported in this 510(k) submission. Instead, the submission relies on the established safety and effectiveness of its predicate devices and the manufacturer's commitment to future testing.

Therefore, I cannot populate the requested table and answer the study-related questions with information from the provided text because such studies were not yet performed at the time of this submission. The manufacturer states they will conduct these tests before sale.

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