Search Results
Found 1 results
510(k) Data Aggregation
(37 days)
Advanced Neuromodulation Systems Lamitrode Spinal Cord Stimulation Leads are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach and are intended to be used with Advanced Neuromodulation Systems extensions and/or, receivers, transmitters, and antennae.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.
The document is a 510(k) clearance letter from the FDA for a device named "C-Series Lamitrode Spinal Cord Stimulation Leads". This letter is a regulatory document indicating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
It does not contain the kind of technical study data that would include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Details on ground truth types or how ground truth was established for training sets.
- Training set sample sizes.
Therefore, I cannot provide the requested table and information as it is not present in the given text.
Ask a specific question about this device
Page 1 of 1