Search Results

The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The PainDoc is intended to assist clinicians and patients in determining the optimum performance while automatically logging procedures data. PainDoc also allows the patient to assist in the optimization of performance by leading them through a series of combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "PainDoc", indicating that the device is substantially equivalent to legally marketed predicate devices.

The letter details:

• The device name: PainDoc
• Its regulation number and name
• Regulatory class: Class II
• The date of clearance
• Indications for Use for the ANS Neurostimulation system and PainDoc.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either test or training sets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this specific information is not present in the provided text.

Ask a specific question about this device