(112 days)
The Pointer-Excel is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Not Found
This looks like a 510(k) clearance letter for a medical device called "Pointer Excel," a transcutaneous electrical nerve stimulator (TENS) for pain relief.
The provided document is a regulatory clearance letter, not a study report or a document that would contain the detailed information requested about acceptance criteria and study methodologies. Therefore, I cannot extract the specific information you've asked for from this text.
Here's why and what kind of document would typically contain that information:
- 510(k) Clearance Letter: This letter from the FDA confirms that a new device is "substantially equivalent" to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and performance as a predicate device, often without requiring extensive new clinical trials like those needed for a Premarket Approval (PMA).
- Missing Information: The letter does not detail specific acceptance criteria, performance metrics, sample sizes, data provenance, expert qualifications, ground truth establishment, or study designs (like MRMC or standalone performance studies). This type of data would typically be found in:
- The 510(k) submission document itself (which is much more extensive than this letter).
- Clinical study reports or validation reports that the manufacturer might have submitted as part of their 510(k) application to demonstrate substantial equivalence, especially if performance data was required.
- Scientific publications if the device underwent independent research.
Therefore, I cannot provide the requested table and study details based on the provided text.
If you had access to the full 510(k) submission for K060517, it might contain some of this information, particularly if performance data was submitted to support substantial equivalence.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).