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The Medtronic X-trel® and Mattrix® Neurostimulation systems are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs. X-trel and Mattrix Receiver Model 3272 systems are also indicated for peripheral nerve stimulation.

Peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

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This FDA 510(k) summary document does not contain information on acceptance criteria or a study proving that a device meets such criteria. It is a letter from the FDA to Medtronic, Inc. notifying them that their Spinal Cord and Peripheral Nerve Stimulation Systems for Pain Relief have been found substantially equivalent to legally marketed predicate devices and can therefore be marketed.

The document includes:

• The FDA's decision on substantial equivalence for the Medtronic devices.
• The regulation numbers, regulatory class, and product codes.
• General information regarding compliance with FDA regulations.
• The approved Indications for Use for the Medtronic X-trel® and Mattrix® Neurostimulation systems.

However, it does not provide any of the specifics requested in your prompt, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size and ground truth establishment for a training set.

This document is a regulatory approval letter, not a clinical study report or a detailed technical submission.

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